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Live data · updated weekly · 414 recalls in 30 days

The Recall Roundup

Everything the FDA has asked companies to take back in the last 30 days: drugs with things floating in them, devices doing things devices shouldn't, and food with ingredients it forgot to mention. The jokes stop at this paragraph. Every recall below is exactly as the FDA reported it.

Recalls
414
Class I (most serious)
29
Drugs
62
Devices
301
Food
51

Since the last update: 70 new recalls added.

Recalls per week, by class · weeks starting May 4 to Oct 19 (latest week may be partial)
FDA recalls per week, stacked by class In the last four full weeks the FDA posted 486 recalls, up from 324 in the four weeks before; 89 were Class I (50 before). 0100200300Class III: 4Class II: 110Class I: 6Week of May 4: 120 recalls (Class I 6, II 110, III 4)Class III: 8Class II: 151Class I: 31Week of May 11: 190 recalls (Class I 31, II 151, III 8)Class II: 68Class I: 19Week of May 18: 87 recalls (Class I 19, II 68, III 0)Class III: 6Class II: 57Class I: 39Week of May 25: 102 recalls (Class I 39, II 57, III 6)Class III: 2Class II: 14Class I: 18Week of Jun 1: 34 recalls (Class I 18, II 14, III 2)Class III: 56Class II: 157Class I: 39Week of Jun 8: 252 recalls (Class I 39, II 157, III 56)Class III: 8Class II: 96Class I: 7Week of Jun 15: 111 recalls (Class I 7, II 96, III 8)Class III: 2Class II: 139Class I: 43Week of Jun 22: 184 recalls (Class I 43, II 139, III 2)Class III: 2Class II: 91Class I: 35Week of Jun 29: 128 recalls (Class I 35, II 91, III 2)Class III: 1Class II: 110Class I: 18Week of Jul 6: 129 recalls (Class I 18, II 110, III 1)Class II: 39Class I: 8Week of Jul 13: 47 recalls (Class I 8, II 39, III 0)Class II: 50Class I: 39Week of Jul 20: 89 recalls (Class I 39, II 50, III 0)Class III: 7Class II: 75Class I: 10Week of Jul 27: 92 recalls (Class I 10, II 75, III 7)Class III: 3Class II: 45Class I: 3Week of Aug 3: 51 recalls (Class I 3, II 45, III 3)Class III: 4Class II: 82Class I: 33Week of Aug 10: 119 recalls (Class I 33, II 82, III 4)Class III: 1Class II: 56Class I: 32Week of Aug 17: 89 recalls (Class I 32, II 56, III 1)Class III: 5Class II: 56Class I: 24Week of Aug 24: 85 recalls (Class I 24, II 56, III 5)Class II: 82Class I: 9Week of Aug 31: 91 recalls (Class I 9, II 82, III 0)Class III: 13Class II: 96Class I: 8Week of Sep 7: 117 recalls (Class I 8, II 96, III 13)Class III: 2Class II: 20Class I: 9Week of Sep 14: 31 recalls (Class I 9, II 20, III 2)Class III: 1Class II: 81Class I: 64Week of Sep 21: 146 recalls (Class I 64, II 81, III 1)Class III: 2Class II: 69Class I: 7Week of Sep 28: 78 recalls (Class I 7, II 69, III 2)Class III: 1Class II: 146Class I: 11Week of Oct 5: 158 recalls (Class I 11, II 146, III 1)Class III: 12Class II: 85Class I: 7Week of Oct 12: 104 recalls (Class I 7, II 85, III 12)Class III: 2Class II: 65Class I: 4Week of Oct 19: 71 recalls (Class I 4, II 65, III 2)May 4Jun 1Jun 29Jul 27Aug 24Sep 21Oct 19

Class I (most serious)Class IIClass III

In the last four full weeks the FDA posted 486 recalls, up from 324 in the four weeks before; 89 were Class I (50 before).

See the numbers
Week ofClass IClass IIClass IIITotal
Oct 19465271
Oct 1278512104
Oct 5111461158
Sep 28769278
Sep 2164811146
Sep 14920231
Sep 789613117
Aug 31982091
Aug 242456585
Aug 173256189
Aug 1033824119
Aug 3345351
Jul 271075792
Jul 203950089
Jul 13839047
Jul 6181101129
Jun 2935912128
Jun 22431392184
Jun 157968111
Jun 83915756252
Jun 11814234
May 2539576102
May 181968087
May 11311518190
May 461104120
Date Product Company Reason Class
Oct 21 HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only) NewDevice · Ongoing · Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA… Instrumentation Laboratory Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. Class I
Oct 21 HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic NewDevice · Ongoing · Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA… Instrumentation Laboratory Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. Class I
Oct 21 Made Fresh brand Black Bean and Corn Salad; 5lb white plastic tubFood · Ongoing · NY Made Fresh Salads Inc Products may be contaminated with Listeria monocytogenes. Class I
Oct 21 Deano's Pasta; Pear and Pecorino Triangoli Ravioli, 1lb.; Ingredients: Dough: Semolina (Wheat, Niacin, Thiamine, Mononitrate, Riboflavin, Folic Acid), Water… NewFood · Ongoing · MA, NH DEANO'S PASTA Undeclared Lobster Class I
Oct 21 Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032. NewDrug · Ongoing · Nationwide in the USA. Houston Rx LLC Lack of process control Class II
Oct 21 Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets… NewDrug · Ongoing · US Nationwide. Teva Pharmaceuticals USA, Inc Presence of Foreign Tablets/Capsules Class II
Oct 21 Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01… NewDrug · Ongoing · US Nationwide American Health Packaging Presence of Foreign Tablets/Capsules Class II
Oct 21 Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed… NewDrug · Ongoing · Nationwide within the United States Zydus Pharmaceuticals (USA) Inc Failed Impurities/Degradation Specifications. Class II
Oct 21 Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032. NewDrug · Ongoing · Nationwide in the USA. Houston Rx LLC Lack of assurance of sterility. Class II
Oct 21 TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. NewDevice · Ongoing · These trays are provided by sale or loan. Loans are provided through… Howmedica Osteonics Corp. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual… Class II
Oct 21 Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821 NewDevice · Ongoing · Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL… Ferno-Washington Inc Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered… Class II
Oct 21 Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514. NewDevice · Ongoing · These trays are provided by sale or loan. Loans are provided through… Howmedica Osteonics Corp. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual… Class II
Oct 21 Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline… NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26… NewDevice · Ongoing · US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain… Cook Incorporated The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this… Class II
Oct 21 Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft… NewDevice · Ongoing · US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL… Medtronic Sofamor Danek USA Inc Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed… Class II
Oct 21 Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A NewDevice · Ongoing · US Nationwide distribution in the state of NY. Medline Industries, LP Discrepancy in the shelf-life of a component Class II
Oct 21 Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M NewDevice · Ongoing · US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. Medline Industries, LP Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures. Class II
Oct 21 Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product… NewDevice · Ongoing · Worldwide - US Nationwide distribution including in the states of Alabama… Baxter Healthcare Corporation Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients… Class II
Oct 21 DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513 NewDevice · Ongoing · Worldwide - US Nationwide distribution including in the states and territory of… Beckman Coulter, Inc. The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual… Class II
Oct 21 Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B… NewDevice · Ongoing · US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. Medline Industries, LP Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures. Class II
Oct 21 Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU… NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU… NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK… NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft… NewDevice · Ongoing · US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL… Medtronic Sofamor Danek USA Inc Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed… Class II
Oct 21 Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135… NewDevice · Ongoing · Worldwide - U.S. Nationwide distribution including in the states and territory… BioFire Diagnostics, LLC Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results Class II
Oct 21 IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50… NewDevice · Ongoing · US Nationwide distribution. INTELERAD MEDICAL SYSTEMS INCORPORATED Following a Chromium-based web-browser, report and displayed images may not match. Class II
Oct 21 TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507. NewDevice · Ongoing · These trays are provided by sale or loan. Loans are provided through… Howmedica Osteonics Corp. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual… Class II
Oct 21 Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU… NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G NewDevice · Ongoing · US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. Medline Industries, LP Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures. Class II
Oct 21 The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a… NewDevice · Ongoing · US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY… Radiometer Medical ApS In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2)… Class II
Oct 21 Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical… NewDevice · Ongoing · Worldwide - US Nationwide distribution in the state of TN and the countries of… Cadwell Industries Inc Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach… Class II
Oct 21 iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm) NewDevice · Ongoing · US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA. SI-BONE, Inc. The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured. Class II
Oct 21 REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm NewDevice · Ongoing · US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA. In2bones USA, LLC Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws. Class II
Oct 21 Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C… NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF… NewDevice · Ongoing · Worldwide - US Nationwide distribution including in the states and territory of… Beckman Coulter, Inc. The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual… Class II
Oct 21 JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L NewDevice · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN… Jenavalve Technology Inc. Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. Class II
Oct 21 RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 NewDevice · Ongoing · Worldwide - US Nationwide distribution. Steris Corporation If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted… Class II
Oct 21 MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control… NewDevice · Ongoing · Worldwide - US Nationwide distribution in the states of UT, MI, OK, NY, TX, CA… Microgenics Corporation Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient… Class II
Oct 21 Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire… NewDevice · Ongoing · US Nationwide distribution in the states of GA, RI. W L Gore & Associates, Inc. The potential for the devices to be mislabeled with the incorrect length. Class II
Oct 21 JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M NewDevice · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN… Jenavalve Technology Inc. Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. Class II
Oct 21 PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H NewDevice · Ongoing · Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA… Ethicon, LLC Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If… Class II
Oct 21 Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product… NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 NewDevice · Ongoing · Worldwide - US Nationwide distribution. Steris Corporation If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted… Class II
Oct 21 FORWARD Gunshot Wound Kit; Model: AFT-GSW; NewDevice · Ongoing · US Nationwide distribution in the states of GA, VA. INTEGRATED MEDCRAFT LLC Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause… Class II
Oct 21 Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit)… NewDevice · Ongoing · Worldwide - U.S. Nationwide distribution including in the states and territory… BioFire Diagnostics, LLC Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results Class II
Oct 21 1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product… NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F NewDevice · Ongoing · US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. Medline Industries, LP Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures. Class II
Oct 21 Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT NewDevice · Ongoing · US Nationwide distribution in the states of IA, IL, IN, KY, MI, MN, MO, ND, OH… Sarnova HC, Llc Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula. Class II
Oct 21 Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST… NewDevice · Ongoing · US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. Medline Industries, LP Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures. Class II
Oct 21 BD Phoenix Panel NMIC-312. Catalog Number: 449082. NewDevice · Ongoing · US Nationwide distribution. Becton Dickinson & Co. Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. Class II
Oct 21 Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model… NewDevice · Ongoing · Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA… Healthmark Industries Co., Inc. Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated. Class II
Oct 21 Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only… NewDevice · Ongoing · US: AZ, CA, FL, IN, LA, NV, RI OUS: None Merit Medical Systems, Inc. The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use. Class II
Oct 21 Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638… NewDevice · Ongoing · US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. Medline Industries, LP Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures. Class II
Oct 21 JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S NewDevice · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN… Jenavalve Technology Inc. Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. Class II
Oct 21 BD Phoenix Panel NMIC-306. Catalog Number: 449292. NewDevice · Ongoing · US Nationwide distribution. Becton Dickinson & Co. Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. Class II
Oct 21 TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. NewDevice · Ongoing · These trays are provided by sale or loan. Loans are provided through… Howmedica Osteonics Corp. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual… Class II
Oct 21 Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack)… NewDevice · Ongoing · Worldwide - U.S. Nationwide distribution including in the states and territory… BioFire Diagnostics, LLC Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results Class II
Oct 21 NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030; NewDevice · Ongoing · US Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD, NC… Boston Scientific Corporation Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration. Class II
Oct 21 Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK… NewDevice · Ongoing · US Nationwide distribution. Medline Industries, LP Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. Class II
Oct 21 NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1… NewDevice · Ongoing · Worldwide distribution - US Nationwide and the countries of Japan and South… Neuronetics, Inc. Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly. Class II
Oct 21 RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 NewDevice · Ongoing · Worldwide - US Nationwide distribution. Steris Corporation If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted… Class II
Oct 21 Stewarts Shops Vanilla Heavenly Medley 1/2 Gallon (1.89 L), UPC Codes: 0 82086 44371 1 NewFood · Ongoing · NY, VT, NH Stewart's Shops Corp. Foreign object: May contain pieces of metal Class II
Oct 21 J. HIGGS Loaded Bacon & Cheddar Potato Chips, NET WT 7.75 OZ (219.7g) bag, UPC 051933316454. Sold as 13 (7.75oz) bags per case. NewFood · Ongoing · The recalled J. HIGGS Loaded Bacon and Cheddar Potato Chips were distributed in… Saratoga Potato Chips LLC Undeclared soy. Class II
Oct 21 Made From Plants; Daring; Plant Steak Bites; Ready in 4 Mins Microwaveable Pouch; UPC: 86001124319 NewFood · Ongoing · Product was distributed to a single retail grocery chain customer with multiple… DARING FOODS INC defective packaging; packaging can rupture/explode during cooking. Class II
Oct 21 Stewarts Shops Vanilla chocolate Strawberry Ice Cream 1/2 gallon (1.89 L), UPC: 0 82086 44377 3 NewFood · Ongoing · NY, VT, NH Stewart's Shops Corp. Foreign object: May contain pieces of metal Class II
Oct 21 Holsum Spinach Flour Tortillas Large, 8 count (20 oz.) UPC: 810023430629 NewFood · Ongoing · PR, US Virgin Islands Holsum De Puerto Rico, Inc. Undeclared colors (FD&C Blue No. 1 and FD&C Yellow No. 5) Class II
Oct 21 LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. NewDevice · Ongoing · US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY. Magellan Diagnostics, Inc. In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an… Class III
Oct 21 Pur Aqua Sparkling Frost Cherry Limeade 17 oz., UPC: 4099100167023 NewFood · Ongoing · Florida with further downstream distribution to retail stores Refresco Beverages US Inc May contain undeclared aspartame. Class III
Oct 14 X10 Natural Enhancement Supplement, 0.5 fl oz/sachet (15 mL), 7 sachets/box, UPC: 7708075247094, Manufactured by FutuPro S.A.S., Colombian Industry…Food · Ongoing · Distributed nationwide (US). A&P CREATIONS Product contains undeclared Sildenafil and Tadalafil. Class I
Oct 14 LEASA Alfalfa Sprouts; packaged in plastic clamshell containers; KEEP REFRIGERATED; NET WT. 6 OZ. (170g); Grown & Packaged by: LEASA Industries Co., Inc., Mami…Food · Ongoing · FL and NH LEASA Industries Co., Inc. Seeds may have been contaminated with E.coli Class I
Oct 14 Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black lettering; label reads in part as "bettergoods Lemon Alfredo Fettuccine…Food · Ongoing · Retail locations nationwide GIAS FOOD INC. Contamination with Listeria monocytogenes Class I
Oct 14 Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration 5 count carton, 6 cartons per case. UPC 850041392103. Paperboard carton…Food · Ongoing · Product was distributed nationwide. The Better Bakehouse Snack Company Undeclared Milk. Class I
Oct 14 Berlin Seeds Alfalfa Sprouting Seeds, packaged in 1/4 lb., 1/2 lb., 1 lb., and 5 lb. resealable bags and 50 lb. woven poly bagsFood · Ongoing · Through the firm's retail store in Millersburg, OH and nationwide through the… Berlin Seeds Product contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella contamination. Class I
Oct 14 biQ-FEL, 16.9 fl oz (500 mL), 17 servings per bottle, Manufactured by ALMENAT SAS AV 39 OESTE No 10 OESTE-18 CALI VALLE INDUSTRIA COLOMBIANA; Distributed by…Food · Ongoing · Distributed nationwide (US). A&P CREATIONS Product contains undeclared Sildenafil and Tadalafil. Class I
Oct 14 LEASA Living Alfalfa Sprouts; packaged in plastic clamshell containers; KEEP REFRIGERATED; NET WT. 4 OZ. (113g); Grown & Packaged by: LEASA Industries Co…Food · Ongoing · FL and NH LEASA Industries Co., Inc. Seeds may have been contaminated with E. coli Class I
Oct 14 Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC…Drug · Ongoing · US Nationwide K.C. Pharmaceuticals, Inc. Lack of Assurance of Sterility Class II
Oct 14 QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II
Oct 14 TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II
Oct 14 Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II
Oct 14 Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II
Oct 14 Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a)…Drug · Ongoing · US Nationwide K.C. Pharmaceuticals, Inc. Lack of Assurance of Sterility Class II
Oct 14 Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd…Drug · Ongoing · USA Nationwide. Cipla USA, Inc. Failed Impurities/Degradation Specifications Class II
Oct 14 Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by…Drug · Ongoing · OH J&J INNOVATIVE MEDICINE Presence of particulate matter. Class II
Oct 14 Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY…Drug · Ongoing · US Nationwide K.C. Pharmaceuticals, Inc. Lack of Assurance of Sterility Class II
Oct 14 Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II
Oct 14 Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.Drug · Ongoing · Nationwide within the United States Apothecary Pharma LLC Lack of Assurance of Sterility Class II
Oct 14 Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05Drug · Ongoing · USA Nationwide Preferred Pharmaceuticals, Inc. Failed Content Uniformity Specifications Class II
Oct 14 Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a)…Drug · Ongoing · US Nationwide K.C. Pharmaceuticals, Inc. Lack of Assurance of Sterility Class II
Oct 14 TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc…Drug · Ongoing · US Nationwide K.C. Pharmaceuticals, Inc. Lack of Assurance of Sterility Class II
Oct 14 TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25Drug · Ongoing · CA BioSpectra, Inc. Failed stability specifications Class II
Oct 14 TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU…Drug · Ongoing · US Nationwide K.C. Pharmaceuticals, Inc. Lack of Assurance of Sterility Class II
Oct 14 SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC…Drug · Ongoing · US Nationwide K.C. Pharmaceuticals, Inc. Lack of Assurance of Sterility Class II
Oct 14 SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina…Drug · Ongoing · Nationwide within the U.S Carolina Infusion, LLC Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class II
Oct 14 Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz…Drug · Ongoing · US Nationwide K.C. Pharmaceuticals, Inc. Lack of Assurance of Sterility Class II
Oct 14 Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.Drug · Ongoing · Nationwide within the United States Apothecary Pharma LLC Lack of Assurance of Sterility Class II
Oct 14 BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007Device · Ongoing · US Nationwide distribution in the state of NJ. Stryker Sustainability Solutions Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma… Class II
Oct 14 VERIFY Biological Steam Test Pack Model/Catalog Number: S3065Device · Ongoing · Worldwide - US Nationwide distribution. Steris Corporation Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological… Class II
Oct 14 Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an…Device · Ongoing · U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI… Medtronic MiniMed, Inc. Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The… Class II
Oct 14 Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside…Device · Ongoing · Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA… PHILIPS MEDICAL SYSTEMS Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion. Class II
Oct 14 Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support…Device · Ongoing · Worldwide distribution - US Nationwide and the country of Canada. Medline Industries, LP The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach… Class II
Oct 14 Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04MDevice · Ongoing · US Nationwide distribution in the states of North Carolina, and California. Onkos Surgical, Inc. Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. Class II
Oct 14 Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05…Device · Ongoing · US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT… Nihon Kohden America LLC Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms. Class II
Oct 14 Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive…Device · Ongoing · Worldwide - US Nationwide distribution including in the states of FL, OK, CA… Safeguard US Operating LLC Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection. Class II
Oct 14 VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006Device · Ongoing · Worldwide - US Nationwide distribution. Steris Corporation Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological… Class II
Oct 14 VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061Device · Ongoing · Worldwide - US Nationwide distribution. Steris Corporation Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological… Class II
Oct 14 Glypto Device, Glypto Cryo Machine;Device · Ongoing · US Nationwide distribution. Limitless Cryo Spa LLC Lack of 510(k) clearance. Class II
Oct 14 VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060Device · Ongoing · Worldwide - US Nationwide distribution. Steris Corporation Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological… Class II
Oct 14 ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007Device · Ongoing · Worldwide - US Nationwide distribution. Steris Corporation Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological… Class II
Oct 14 ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04MDevice · Ongoing · US Nationwide distribution in the states of North Carolina, and California. Onkos Surgical, Inc. Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. Class II
Oct 14 CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control…Device · Ongoing · Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand. Steris Corporation A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect… Class II
Oct 14 UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 VERIFY Biological Steam Test Pack Model/Catalog Number: S3069Device · Ongoing · Worldwide - US Nationwide distribution. Steris Corporation Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological… Class II
Oct 14 Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support…Device · Ongoing · Worldwide distribution - US Nationwide and the country of Canada. Medline Industries, LP The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach… Class II
Oct 14 GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit…Device · Ongoing · Pending Cardinal Health 200, LLC Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a… Class II
Oct 14 DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module…Device · Ongoing · Worldwide - US Nationwide distribution. Beckman Coulter Inc. Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system… Class II
Oct 14 SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;Device · Ongoing · Worldwide - US Nationwide distribution in the states and territory of AK, AR… POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting… Class II
Oct 14 DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 HALYARD Laparoscopy Comprehensive Pack II REF: 49332Device · Ongoing · US Nationwide distribution in the state of MS. GRI Medical & Electronic Technology Co., Ltd. Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter Class II
Oct 14 Alphenix INFX-8000C/B5Device · Ongoing · US Nationwide distribution in the state of ID. Canon Medical System, USA, INC. Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error Class II
Oct 14 DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520Device · Ongoing · Worldwide - US Nationwide distribution. Beckman Coulter Inc. Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system… Class II
Oct 14 LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker)…Device · Ongoing · U.S. Nationwide distribution in the states of CA and TX. QUANTUM OPS Inc Due to a manufacturing issue (inadequate weld) for patient head positioning system. Class II
Oct 14 Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF…Device · Ongoing · Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the… Intellijoint Surgical, Inc. A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may… Class II
Oct 14 Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);Device · Ongoing · Worldwide - US Nationwide distribution in the state of NJ and the countries of… DRG International, Inc. Potential for false negative patient results. Class II
Oct 14 TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;Device · Ongoing · US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC. LeMaitre Vascular, Inc. Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. Class II
Oct 14 PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 HEART PREP TRAY; Model/Item Number (Kit): MECV97W;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 PLASTICS TRAY; Model/Item Number (Kit): EURO053;Device · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. AVID Medical, Inc. Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II
Oct 14 QUESO PALMITA. Generic Name: Pastel de Queso (Cheese Pie). Intended use: Human consumption. Condition: Frozen. Shelf life or expected life: 90 days. Type of…Food · Ongoing · Texas QUESO PALMITA GP LLC Undeclared milk, cheese declared Class II
Oct 14 Saint Francis Apizza Frozen Pepperoni Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27762 1Food · Ongoing · KY, OH Saint Francis Apizza LLC Undeclared soy allergen: soybean oil and soy lecithin Class II
Oct 14 Chocolate Chip Cookies packaged in a cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic…Food · Ongoing · NY and NJ J K Patisserie & Bakery LLC Soy was not declared in the Contains statement. Class II
Oct 14 WinCo Foods Salsa Bean Dip Express Tray is packaged in a foil bottom container with clear plastic lid. Net Wt. 54oz. UPC 2 67173 510983. WinCo Foods Salsa Bean…Food · Completed · Distributed in AZ, CA, ID, MT, NV, OR, UT, and WA. WinCo Foods LLC Bean Dip Trays contains recalled Peperoncini (pepper) which was recalled due to pest issue. Class II
Oct 14 Croissant; packaged in cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid, malted…Food · Ongoing · NY and NJ J K Patisserie & Bakery LLC Egg was not declared in the Contains statement. Class II
Oct 14 Saint Francis Apizza Frozen Cheese Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27759 1Food · Ongoing · KY, OH Saint Francis Apizza LLC Undeclared soy allergen: soybean oil and soy lecithin Class II
Oct 14 Mezzetta GOLDEN GREEK PEPERONCINI MEDIUM HEAT 32 FL OZ G.L. MEZZETTA, INC., AMERICAN CANYON, NAPA VALLEY, CA 94503 PRODUCT OF GREECE UPC: 073214003280Food · Ongoing · Domestic: AZ, CA, CO, GA, IA, ID, IL, IN, MI, MN, MO, NC, OH, OK, OR, PA, SD… G L Mezzetta Inc Potential contamination with foreign objects: mice. Class II
Oct 14 Saint Francis Apizza Frozen Supreme Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27760 7Food · Ongoing · KY, OH Saint Francis Apizza LLC Undeclared soy allergen: soybean oil and soy lecithin Class II
Oct 14 Lemon Blueberry Loaf packaged in a cardboard box; Ingredients: King midas flour, Veribest pastry flour, Granulated Sugar, Blueberries frozen IQF, Milk, Canola…Food · Ongoing · NY and NJ J K Patisserie & Bakery LLC Product contains undeclared soybean oil and soy lecithin in the Ingredient Statement. Soy was not declared in the Contains statement. Class II
Oct 14 Saint Francis Apizza Frozen Mushroom & Onion Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27764 5Food · Ongoing · KY, OH Saint Francis Apizza LLC Undeclared soy allergen: soybean oil and soy lecithin Class II
Oct 14 28 oz. Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange Zero.Food · Ongoing · AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS… Pepsico Inc Undeclared Yellow No. 6 and/or Yellow No. 5 Class II
Oct 14 Sweet Sensi Elevated Edibles Hybrid Gum Drops - Passion Guava Kush 140mg THC. Product is packaged in sealable & flexible gold, purple and black metallic…Food · Ongoing · Nationwide SWEET SENSI Staphylococcus aureus detected in product. Class II
Oct 14 Cranberry Chicken Salad Wedge 4.5 oz package in Wedge plastic and clear container with a plastic film sealing the top.Food · Ongoing · Florida and Georgia FRESHPOINT CENTRAL FLORIDA, INC. The chicken salad sandwich has an improperly declared allergen (egg). While egg is included in the ingredients list on the package label, it is not included in the allergen Contains statement. Class II
Oct 14 Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario…Drug · Ongoing · US Nationwide. SUN PHARMACEUTICAL INDUSTRIES INC Failed Impurities/Degradation Specifications Class III
Oct 14 Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc…Drug · Ongoing · US Nationwide. SUN PHARMACEUTICAL INDUSTRIES INC Failed Impurities/Degradation Specifications Class III
Oct 14 Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc…Drug · Ongoing · US Nationwide. SUN PHARMACEUTICAL INDUSTRIES INC Failed Impurities/Degradation Specifications Class III
Oct 14 ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10ADevice · Ongoing · Worldwide - Nationwide and the country of Canada. Mindray DS USA, Inc. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class III
Oct 14 BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.Device · Ongoing · Worldwide - Nationwide and the country of Canada. Mindray DS USA, Inc. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class III
Oct 14 Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software…Device · Ongoing · U.S.: CA O.U.S.: N/A Medical Action Industries, Inc. 306 An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027. Class III
Oct 14 Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).Device · Ongoing · Worldwide - Nationwide and the country of Canada. Mindray DS USA, Inc. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class III
Oct 14 BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80Device · Ongoing · Worldwide - Nationwide and the country of Canada. Mindray DS USA, Inc. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class III
Oct 14 cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12Device · Ongoing · Worldwide - Nationwide and the country of Canada. Mindray DS USA, Inc. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class III
Oct 14 BeneView Series. Operator's Manuals: T5 / T8Device · Ongoing · Worldwide - Nationwide and the country of Canada. Mindray DS USA, Inc. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class III
Oct 14 T1 Patient Monitor. Operator's Manual: T1 Patient MonitorDevice · Ongoing · Worldwide - Nationwide and the country of Canada. Mindray DS USA, Inc. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class III
Oct 14 Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / VDevice · Ongoing · Worldwide - Nationwide and the country of Canada. Mindray DS USA, Inc. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class III
Oct 14 Tri-Immune Boost (Glutathione: 200 mg, Ascorbic Acid: 200 mg, Zinc: 2.5 mg), 30 mL vial, Rx only, Centric Compounding, 7447 Harwin Dr. Suite 111, Houston, TX…Drug · Ongoing · USA Nationwide. Centric Compounding LLC Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. Not Yet Classified
Oct 14 SIERRA NEVADA CHEESE GRAZIERS RAW MILK SHARP CHEDDAR NET WT. 40 LBS Item 6516Food · Ongoing · Domestic: AZ, CA, CO, FL, GA, IL, IN, MD, NJ, OR, TX, WA, WI. Foreign: Not… Sierra Nevada Cheese Company, Inc Potential contamination due to E. coli O26:H11. Not Yet Classified
Oct 7 Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITEDevice · Ongoing · Distribution US Nationwide including territories of Puerto Rico and Guam and… Medline Industries, LP Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire… Class I
Oct 7 Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR530094…Device · Ongoing · Distribution US Nationwide including territories of Puerto Rico and Guam and… Medline Industries, LP Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire… Class I
Oct 7 VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.Device · Ongoing · US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO… Draeger, Inc. Potential cracks in the hose, which could lead to leakage or the hose falling off. Class I
Oct 7 Todd's Seeds Salad Sprouting Mixture - Broccoli, Mustard, Alfalfa and Cabbage, packaged in heat-sealed resealable bags in the following sizes: 1/4 lb., 1/2…Food · Ongoing · Nationwide; through Amazon or direct to consumer TODD'S SEEDS LLC Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Class I
Oct 7 Todd's Seeds Broccoli & Friends Sprouting Seed Mix - Broccoli, Alfalfa, Radish, Clover, packaged in 1 oz. sample packets and heat-sealed resealable bags in the…Food · Ongoing · Nationwide; through Amazon or direct to consumer TODD'S SEEDS LLC Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Class I
Oct 7 Coco G's Courmet Flaming Cheddar Hots, Spicy Cheddar Cheese Popcorn. Packaged in the following sized plastic bags: 1. 2.5 oz (81g), UPC 6 94161-25911 9. 2…Food · Ongoing · IL, WI Coco G's Snack Foods, Inc. Potential Salmonella contamination. Class I
Oct 7 Salata Salad Kitchen Jalapen¿o Avocado Dressing. Keep Refrigerated. Packaged in the following sizes: 1. 12.5 fl. oz. (369 mL), UPC 8 50043-70646 5. 2. 1 gallon…Food · Ongoing · GA, NC, TX Salata Dressings, LLC This recall was initiated due to potential Salmonella contamination in diced jalape¿no received from the supplier Class I
Oct 7 Todd's Seeds Variety Pack of Sprouting Seeds - Broccoli, Alfalfa, Radish Mung & Clover, packaged as a multi-pack consisting of 2 oz. heat-sealed resealable…Food · Ongoing · Nationwide; through Amazon or direct to consumer TODD'S SEEDS LLC Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Class I
Oct 7 Todd's Seeds Alfalfa & Mung Bundle (1lb each), packaged separately in heat-sealed resealable bagsFood · Ongoing · Nationwide; through Amazon or direct to consumer TODD'S SEEDS LLC Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Class I
Oct 7 Todd's Seeds Sprouting Seed Mix - Broccoli, Radish, Alfalfa, packaged in heat-sealed resealable bags in the following sizes: 1/4 lb., 1/2 lb., 1 lb., and 5 lb.Food · Ongoing · Nationwide; through Amazon or direct to consumer TODD'S SEEDS LLC Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Class I
Oct 7 Todd's Seeds Alfalfa Sprouting Seeds, packaged in heat-sealed resealable bags in the following sizes: 1/4 lb., 1/2 lb., 1 lb., 2.5 lb., and 5 lb.Food · Ongoing · Nationwide; through Amazon or direct to consumer TODD'S SEEDS LLC Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Class I
Oct 7 Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351-42), Distributed…Drug · Ongoing · IL only SV Labs Toronto Corporation Microbial contamination of topical product. Class II
Oct 7 Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.Drug · Ongoing · Nationwide in the USA. Amneal Pharmaceuticals, LLC Defective Container; packets were found to be either empty or partially full. Class II
Oct 7 FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19Drug · Ongoing · VA Aurolab Trust Lack of Assurance of Sterility Class II
Oct 7 Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY…Drug · Ongoing · USA Nationwide TerSera Therapeutics LLC Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours. Class II
Oct 7 Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex…Drug · Ongoing · US Nationwide. Apotex Corp. Failed dissolution specifications. Class II
Oct 7 Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC…Drug · Ongoing · IL only SV Labs Toronto Corporation Microbial contamination of topical product. Class II
Oct 7 Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05Drug · Ongoing · U.S. Nationwide Par Health USA, LLC Crystallization Class II
Oct 7 Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02Drug · Ongoing · Nationwide in the US. Ajanta Pharma USA Inc Failed Dissolution Specifications: below specification Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107001 Software Version: Not…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE Model/Catalog Number: A70107017 Software…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A…Device · Ongoing · US Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC… SPECTRUM MEDICAL SRL Due to blood-to-glycol leak in the heat exchanger. Class II
Oct 7 Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF…Device · Ongoing · Worldwide - US Nationwide distribution in the states of CA, GA and the… Merit Medical Systems, Inc. Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection. Class II
Oct 7 Computed Tomography X-ray System, Model: uCT 530 with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HCDevice · Ongoing · Worldwide - US Nationwide distribution including in the states of CA, PA, OK… Percussionaire Corporation Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting… Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog Number: DT-7044-02Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1-LINE (CS 10) NAVY BLUE Model/Catalog Number: 564017 Software Version: Not…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW…Device · Ongoing · US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX. Cardinal Health 200, LLC The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user… Class II
Oct 7 Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Product…Device · Ongoing · US Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC… SPECTRUM MEDICAL SRL Due to blood-to-glycol leak in the heat exchanger. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 18) RED Model/Catalog Number: A70107007 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP…Device · Ongoing · US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and… American Contract Systems Inc Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to… Class II
Oct 7 Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VADevice · Ongoing · Worldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA… Volcano Corp Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 18) YELLOW Model/Catalog Number: A70107008 Software Version: Not…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B…Device · Ongoing · U.S. Nationwide distribution in the state of TX. Custom Interventional Pain Management, LLC Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits. Class II
Oct 7 Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction ManualDevice · Ongoing · Worldwide - US Nationwide distribution including in the states of CA, PA, OK… Percussionaire Corporation Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting… Class II
Oct 7 Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile…Device · Ongoing · US Nationwide distribution. American Nitrile Operations Llc Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination… Class II
Oct 7 Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT…Device · Ongoing · US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT… Penumbra Inc. Due to manufacturing issues reperfusion catheters may fracture. Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE Model/Catalog Number: A70107014 Software…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262…Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Computed Tomography X-ray System, Model: uCT 550 with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-564012 Software Version: Not Applicable Product…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T)…Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number…Device · Ongoing · US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX. Cardinal Health 200, LLC The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user… Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 38" X 4" 1-LINE (CS 10) Model/Catalog Number: 564044 Software Version: Not Applicable Product…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-Line, Red Model/Catalog Number: ASP-564007 Software Version: Not Applicable Product…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333Device · Ongoing · U.S. and U.S. Territories. Philips North America Llc The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional… Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 12) GREEN Model/Catalog Number: A70107012 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Computed Tomography X-ray System, Model: uCT 780 with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Computed Tomography X-ray System, Model: uCT ATLAS with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025…Device · Ongoing · Worldwide - US Nationwide distribution including in the states of IL, PA, FL… Alere San Diego, Inc. hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Class II
Oct 7 Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7024-02Q Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 18) RED Model/Catalog Number: A70107006 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog Number: DT-7018-01Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 In-Line Valve, Product Number: P5-TEEDevice · Ongoing · Worldwide - US Nationwide distribution including in the states of CA, PA, OK… Percussionaire Corporation Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting… Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 1-LINE (CS 12) ORANGE Model/Catalog Number: A70107016 Software…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130Device · Ongoing · Worldwide - US Nationwide distribution in the states of TX, KS, NC, CA, UT, KA… Illumina, Inc. Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability. Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White Model/Catalog Number: ASP-564010 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 12) GRAY Model/Catalog Number: A70107005 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction ManualDevice · Ongoing · Worldwide - US Nationwide distribution including in the states of CA, PA, OK… Percussionaire Corporation Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting… Class II
Oct 7 Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.Device · Ongoing · International distribution to the country of Japan. Olympus Corporation of the Americas There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. Class II
Oct 7 Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield…Device · Ongoing · U.S. Nationwide distribution in the states of GA and TX. Micro Therapeutics, Inc. Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter. Class II
Oct 7 Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7020-02Q Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN Model/Catalog Number: 564015 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog Number: DT-7034-01Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with softwareDevice · Ongoing · US Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC, ID… Bard Peripheral Vascular Inc Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to… Class II
Oct 7 Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 1 LINE (10) Model/Catalog Number: DB-7018-01Q Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH¿…Device · Ongoing · US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and… American Contract Systems Inc Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to… Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 10) GREEN Model/Catalog Number: 564014 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog Number: DT-7024-01Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074…Device · Ongoing · Worldwide - US Nationwide distribution including in the states of IL, PA, FL… Alere San Diego, Inc. hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE Model/Catalog Number: 564013 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled…Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Aland Islands… Heraeus Medical GmbH (Dental Division) Potential for monomer liquid leakage. Class II
Oct 7 Computed Tomography X-ray System, Model: uCT ATLAS Astound with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 10) GRAY Model/Catalog Number: 564005 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 1-LINE (CS 12) GRAY Model/Catalog Number: A70107004 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7…Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 1-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107000 Software Version: Not…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red Model/Catalog Number: ASP-564006 Software Version: Not Applicable Product…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTCDevice · Ongoing · US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX. Cardinal Health 200, LLC The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user… Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating SystemDevice · Ongoing · US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ… Wright Medical Technology, Inc. Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the… Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog Number: DT-7044-01Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub SystemDevice · Ongoing · Worldwide distribution - US Nationwide and the country of Poland. Olympus Corporation of the Americas While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable. Class II
Oct 7 Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Computed Tomography X-ray System, Model: uCT 760 with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 10) Model/Catalog Number: 564001 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7…Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Model/Catalog Number: DT-7030-02Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 10) WHITE Model/Catalog Number: 564011 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1-LINE (CS 10) ORANGE Model/Catalog Number: 564019 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.Device · Ongoing · International distribution to the country of Japan. Olympus Corporation of the Americas There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. Class II
Oct 7 Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue…Device · Ongoing · US Nationwide distribution. American Nitrile Operations Llc Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination… Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Model/Catalog Number: DT-7112-02Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Model/Catalog Number: DT-7030-01Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-Line, Blue Model/Catalog Number: ASP-564013 Software Version: Not Applicable Product…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972…Device · Ongoing · Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA… Beckman Coulter Mishima K.K. Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC… Class II
Oct 7 Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction ManualDevice · Ongoing · Worldwide - US Nationwide distribution including in the states of CA, PA, OK… Percussionaire Corporation Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting… Class II
Oct 7 McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific…Device · Ongoing · Worldwide - US Nationwide distribution including in the states of IL, PA, FL… Alere San Diego, Inc. hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Class II
Oct 7 Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number…Device · Ongoing · US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX. Cardinal Health 200, LLC The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user… Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS…Device · Ongoing · US Nationwide distribution. Tandem Diabetes Care, Inc. A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose… Class II
Oct 7 Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AODevice · Ongoing · US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and… American Contract Systems Inc Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to… Class II
Oct 7 PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a…Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Aland Islands… Heraeus Medical GmbH (Dental Division) Potential for monomer liquid leakage. Class II
Oct 7 PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into…Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Aland Islands… Heraeus Medical GmbH (Dental Division) Potential for monomer liquid leakage. Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE (10) Model/Catalog Number: DT-7108-02Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with softwareDevice · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 10) YELLOW Model/Catalog Number: 564009 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Argentina… Siemens Healthcare Diagnostics, Inc. The potential for falsely elevated results. Class II
Oct 7 Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile…Device · Ongoing · US Nationwide distribution. American Nitrile Operations Llc Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination… Class II
Oct 7 Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction ManualDevice · Ongoing · Worldwide - US Nationwide distribution including in the states of CA, PA, OK… Percussionaire Corporation Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting… Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED Model/Catalog Number: 564006 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-Line, Yellow Model/Catalog Number: ASP-564009 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-Line, Green Model/Catalog Number: ASP-564014 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 12) PLUM Model/Catalog Number: A70107003 Software Version: Not…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Model/Catalog Number: DT-7034-02Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Positron Emission Tomography and Computed Tomography System, Model: uMI 780Device · Ongoing · US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID… Shanghai United Imaging Healthcare Co., Ltd. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images… Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 18) YELLOW Model/Catalog Number: A70107009 Software Version: Not…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 18) BLUE Model/Catalog Number: A70107010 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000…Device · Ongoing · Worldwide - US Nationwide distribution including in the states of IL, PA, FL… Alere San Diego, Inc. hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Class II
Oct 7 Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 12) GREEN Model/Catalog Number: A70107013 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with…Device · Ongoing · Worldwide - US Nationwide distribution including in the states of CA, PA, OK… Percussionaire Corporation Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting… Class II
Oct 7 PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a…Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Aland Islands… Heraeus Medical GmbH (Dental Division) Potential for monomer liquid leakage. Class II
Oct 7 NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.Device · Ongoing · US Nationwide distribution in the state of Georgia. NOXBOX LTD Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors. Class II
Oct 7 Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 1-LINE (CS 12) PLUM Model/Catalog Number: A70107002 Software Version: Not…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 1 LINE (10) Model/Catalog Number: DT-7115-01Q Software Version: Not Applicable Product Description…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-Line, Yellow Model/Catalog Number: ASP-564008 Software Version: Not Applicable…Device · Ongoing · US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT… ASP Global, LLC. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. Class II
Oct 7 HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visualization of the…Device · Ongoing · U.S. Nationwide distribution in the states of AZ, CA and MO. Karl Storz Endoscopy Due to incorrect inside packaging label for eyepiece. Class II
Oct 7 SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1…Device · Ongoing · Worldwide distribution - Nationwide and the countries of Algeria, Argentina… Philips North America When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction… Class II
Oct 7 Lior brand Cinnamon Ground Seasoning; 90g transparent plastic container; UPC 794711005484.Food · Ongoing · NY, NJ, PA, TX, FL, IL Galil Importing Corp Product contains elevated levels of lead. Class II
Oct 7 Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil, packaged in 3.4 fl oz (100mL), 8.5 fl oz (250mL), and 17 fl oz (500mL) glass bottles, UPC…Food · Ongoing · Distributed directly to consumers in CA, FL, IL, KY, MO, NC, OH, OR, TN, TX… LMSI, LLC Product contains garlic essential oil not approved for culinary use Class II
Oct 7 7up Tropical beverage, shelf stable, 12oz can in a 12pk wrap, labeled as 7 up Tropical Beverage containing cans that are labeled as 7Up Tropical Zero Sugar…Food · Completed · Product was distributed to Utah. Admiral Beverage Corporation Product may contain undeclared sugar. Class II
Oct 7 Khazana The Treasure Spice Magic Fennel Candy, 5 lbs., Poly Plastic Bag, 4 per caseFood · Ongoing · The product was distributed to: NY SLT Foods Inc. Undeclared Yellow 5 & 6, Red 3, and Blue 1 Class II
Oct 7 Cloud Cafe branded Collagen Milk; Strawberry Milk Zero; Caffeine Free; 10pc/boxFood · Ongoing · Product was sold to a single distributor located in Los Angeles. TOJI CO. Undeclared allergen ingredient (fish) Class II
Oct 7 Organiccs Absolutely Pure, Type-1 Hydrolyzed Collagen Peptides, All-Natural Aid for Strengthening Hair, Skin, Nails, Muscles & Joints, 180 Veggie Capsules…Food · Ongoing · Product is primarily distributed to private practice medical offices in… Pacific Health Sciences Llc Undeclared shellfish (crab shell): source of ingredient Glucosamine sulfate Class II
Oct 7 HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US…Device · Ongoing · U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT… HeartSine Technologies Ltd Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check. Class III
Oct 7 amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made…Drug · Ongoing · US Nationwide. Aurobindo Pharma USA Inc Discoloration: consumer complaints received for discolored tablets Not Yet Classified
Sep 30 INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709…Device · Ongoing · Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA… CooperSurgical, Inc. Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and… Class I
Sep 30 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.Device · Ongoing · US Nationwide distribution. AVID Medical, Inc. Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides. Class I
Sep 30 Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031…Device · Ongoing · Worldwide - US Nationwide and territories of Puerto Rico and the countries of… Boston Scientific Corporation Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism. Class I
Sep 30 INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710…Device · Ongoing · Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA… CooperSurgical, Inc. Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and… Class I
Sep 30 Fromagerie Coop de Mean Cabricharme and Belgium Cabricharme Shelf life: 30 days, all dates through and including 10/7/2026 Packaging: Plastic wrapped by slice…Food · Ongoing · CA, AZ, NJ, MA, RI, CT, NY WFM Purchasing, LP Undeclared Egg Allergen Class I
Sep 30 Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black lettering; label reads in part as "bettergoods Lemon Alfredo Fettuccine…Food · Ongoing · Walmart DCs and retail locations nationwide. GIAS FOOD INC. Contamination with Listeria monocytogenes Class I
Sep 30 Evergreen Fresh Sprouts LLC, Broccoli Sprouts, packaged in clear plastic zip lock bag, net wt. 4oz, UPC 8 38796 00105 1. Firm distributed cases (6/4oz. bags…Food · Ongoing · Distributed in WA Evergreen Fresh Sprouts LLC Salmonella Class I
Sep 30 TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured…Drug · Ongoing · USA Nationwide Sterling Pharmaceutical Services LLC Lack of Assurance of Sterility Class II
Sep 30 AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin…Drug · Ongoing · USA Nationwide Sterling Pharmaceutical Services LLC Lack of Assurance of Sterility Class II
Sep 30 Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper…Drug · Ongoing · Nationwide in the USA. Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company Lack of Assurance of Sterility Class II
Sep 30 AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN…Drug · Ongoing · USA Nationwide Sterling Pharmaceutical Services LLC Lack of Assurance of Sterility Class II
Sep 30 Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron…Drug · Ongoing · USA Nationwide Sterling Pharmaceutical Services LLC Lack of Assurance of Sterility Class II
Sep 30 Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories…Drug · Ongoing · USA Nationwide Sterling Pharmaceutical Services LLC Lack of Assurance of Sterility Class II
Sep 30 Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL…Drug · Ongoing · USA Nationwide Sterling Pharmaceutical Services LLC Lack of Assurance of Sterility Class II
Sep 30 Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal…Drug · Ongoing · USA Nationwide Amneal Pharmaceuticals of New York, LLC Defective Delivery System: Possibility of no medication in the prefilled pen. Class II
Sep 30 Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233…Drug · Ongoing · USA Nationwide Sterling Pharmaceutical Services LLC Lack of Assurance of Sterility Class II
Sep 30 Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200…Drug · Ongoing · USA Nationwide Sterling Pharmaceutical Services LLC Lack of Assurance of Sterility Class II
Sep 30 Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle…Drug · Ongoing · Nationwide in the USA. Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company Lack of Assurance of Sterility Class II
Sep 30 Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580…Drug · Ongoing · USA Nationwide Sterling Pharmaceutical Services LLC Lack of Assurance of Sterility Class II
Sep 30 MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan…Drug · Ongoing · CA only SHANTOU Qiwei industrial Co., Ltd cGMP Deviations Class II
Sep 30 Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Canada, Latin… Olympus Corporation of the Americas Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Class II
Sep 30 Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.Device · Ongoing · US Nationwide distribution in the states of MN and SD. Medline Industries, LP Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion… Class II
Sep 30 Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen…Device · Ongoing · US Nationwide distribution. Midmark Corporation A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. Class II
Sep 30 Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code…Device · Ongoing · Worldwide - US Nationwide and the countries of Austria, Belgium, Canada… Abiomed, Inc. Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system… Class II
Sep 30 Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen…Device · Ongoing · US Nationwide distribution. Midmark Corporation A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. Class II
Sep 30 CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;Device · Ongoing · Domestic: Nationwide Distribution; Fresenius Medical Care Renal Therapies Group, LLC Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. Class II
Sep 30 Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X)…Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1RDevice · Ongoing · US Nationwide distribution including in the states and territory of AL, AZ, CA… Criticare Technologies, Inc. Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay. Class II
Sep 30 Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen…Device · Ongoing · US Nationwide distribution. Midmark Corporation A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. Class II
Sep 30 VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811Device · Ongoing · International distribution to the countries of Austria, Germany, Luxembourg. Biomerieux Inc The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False… Class II
Sep 30 MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 MR 5300 Model Number (REF): 1. 782110, 2. 782152;Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… INTERVASCULAR, SAS Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). Class II
Sep 30 Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Canada, Latin… Olympus Corporation of the Americas Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Class II
Sep 30 Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6…Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.Device · Ongoing · International distribution in the country of Japan. Olympus Corporation of the Americas Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm, Class II
Sep 30 Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF…Device · Ongoing · US Nationwide. Medline Industries, LP The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as… Class II
Sep 30 Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform…Device · Ongoing · Worldwide - US Nationwide distribution in the state of Massachusetts and the… Heidelberg Engineering GmbH Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries… Class II
Sep 30 REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post ValveDevice · Ongoing · US Nationwide distribution in the states of FL, IA, OH, NE, TN. Ventec Life Systems, Inc. Labeling; Oxygen Cylinders do not contain required medical gas labeling Class II
Sep 30 New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100…Device · Ongoing · US Nationwide distribution in the state of Connecticut. New York Embroidery Studio, Inc. Gowns do not consistently meet the minimum liquid-barrier performance required. Class II
Sep 30 REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 SeriesDevice · Ongoing · US Nationwide distribution in the states of LA,MO, MD, TN, UT. DeRoyal Industries Inc Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle. Class II
Sep 30 Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based…Device · Ongoing · Worldwide distribution - US Nationwide and the country of Canada. Baxter Healthcare Corporation There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect… Class II
Sep 30 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02Device · Ongoing · US Nationwide distribution. AVID Medical, Inc. Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. Class II
Sep 30 Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Canada, Latin… Olympus Corporation of the Americas Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Class II
Sep 30 Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE…Device · Ongoing · US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX. Cardinal Health 200, LLC The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or… Class II
Sep 30 Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 dayDevice · Ongoing · US Nationwide distribution in the states of MN, OH, WI. CooperVision, Inc. A small number of lenses within the affected lot are of the incorrect power. Class II
Sep 30 REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated ConserverDevice · Ongoing · US Nationwide distribution in the states of FL, IA, OH, NE, TN. Ventec Life Systems, Inc. Labeling; Oxygen Cylinders do not contain required medical gas labeling Class II
Sep 30 Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;Device · Ongoing · US Nationwide distribution. Maquet SAS The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury. Class II
Sep 30 Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15Device · Ongoing · US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX. Cardinal Health 200, LLC The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or… Class II
Sep 30 Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Canada, Latin… Olympus Corporation of the Americas Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Class II
Sep 30 Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen…Device · Ongoing · US Nationwide distribution. Midmark Corporation A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. Class II
Sep 30 Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234Device · Ongoing · Worldwide - US Nationwide distribution in the states of AL, CA, CT, FL, GA, KS… Philips Ultrasound, LLC Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis. Class II
Sep 30 SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12Device · Ongoing · US Nationwide distribution in the states of Alabama, California, Colorado… SEASPINE ORTHOPEDICS CORPORATION The proximal thread depth of the spinal device is out of design specification. Class II
Sep 30 Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF…Device · Ongoing · US Nationwide. Medline Industries, LP The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as… Class II
Sep 30 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01Device · Ongoing · US Nationwide distribution. AVID Medical, Inc. Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. Class II
Sep 30 Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera…Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.Device · Ongoing · US Nationwide distribution in the states of MN and SD. Medline Industries, LP Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion… Class II
Sep 30 HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post ValveDevice · Ongoing · US Nationwide distribution in the states of FL, IA, OH, NE, TN. Ventec Life Systems, Inc. Labeling; Oxygen Cylinders do not contain required medical gas labeling Class II
Sep 30 Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct…Device · Ongoing · Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR… Becton, Dickinson and Company Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. Class II
Sep 30 Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH…Device · Ongoing · US Nationwide distribution in the states of Colorado and Florida. Baxter Healthcare Corporation Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications. Class II
Sep 30 PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide…Device · Ongoing · Worldwide distribution - US Nationwide and the country of Canada. Baxter Healthcare Corporation There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect… Class II
Sep 30 PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based…Device · Ongoing · Worldwide distribution - US Nationwide and the country of Canada. Baxter Healthcare Corporation There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect… Class II
Sep 30 Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY…Device · Ongoing · US Nationwide. Medline Industries, LP The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as… Class II
Sep 30 Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283…Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1…Device · Ongoing · Worldwide distribution - US Nationwide and the countries of Albania, Algeria… Philips North America Llc A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Class II
Sep 30 Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number…Device · Ongoing · US Nationwide. Medline Industries, LP The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as… Class II
Sep 30 Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325ADevice · Ongoing · US Nationwide. Medline Industries, LP The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as… Class II
Sep 30 Light Brown Sugar, Packaged in he follow configurations: 1. United, Net Wt. 50 lbs., (22.68kg). Item Number 810051. Distributed By: United Sugar Producers &…Food · Ongoing · IA, IL, IN, KS, MN, OH PA, TX United Sugar Producers and Refiners Potential Wheat Kernel contamination. Class II
Sep 30 Powdered Sugar, Packaged in the following configurations: 1. United 6X, Net Wt. 50 lbs. (22.68kg), Item Number 810087. UPC 7 85921-07090 4. Distributed by…Food · Ongoing · IA, IL, IN, KS, MN, OH PA, TX United Sugar Producers and Refiners Potential Wheat Kernel contamination. Class II
Sep 30 So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert. 16 oz paper tub with an attached paper lid. Sold as a single unit multi…Food · Ongoing · Product was distributed nationwide. WWF Operating Company Product may contain foreign material: small stones and other hard objects. Class II
Sep 30 Pecorino Toscano D.O.P. STAGIONATO cheese wheels. Product of Italy. Each cheese wheel is approximately 3-4 lbs. Wheels contain a wax rind. Keep Refrigerated…Food · Ongoing · WI Elegant Foods, LLC Potential Listeria contamination from dripping condensation in cooler. Class II
Sep 30 Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods…Drug · Ongoing · Nationwide in the USA Macleods Pharmaceuticals Limited Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. Class III
Sep 30 American Ginsengs. PRODUCT OF WISCONSIN. NET WT: 4 oz. NET WT. 8 oz.Food · Ongoing · Domestic: CA. Foreign: Not Applicable. Kwok Shing, Inc. Potential contamination with pesticides. Class III
What the classes mean, and where this comes from

Class I: a reasonable chance the product could cause serious health problems or death. Class II: could cause temporary or medically reversible health problems, or the chance of serious harm is remote. Class III: unlikely to cause health problems, but breaks FDA rules.

If you have a recalled product, follow the instructions from the company or the FDA. Don't stop a prescription medicine without asking your pharmacist or clinician first.

Source: openFDA enforcement reports, U.S. Food and Drug Administration, via FDA's public API. FDA data as of 2026-10-21; fetched 2026-10-29. openFDA data is unvalidated and shouldn't be used alone for medical decisions. Official notices: FDA recalls, market withdrawals and safety alerts.

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