The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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23351–23375 of 40175

  • SevereFDA (Devices)·Z-2208-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 7 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M150373
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2227-2018·2018-06-20

    Seaberg SAM XT-C Tourniquet Recall Due to Potential Buckle Failure

    The Seaberg Company is recalling SAM XT-C tourniquets because internal testing showed stitches securing the buckle might fail, posing a risk of serious injury or death.

    Product
    Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
    Category
    Medical Device
    Distribution
    23 states
  • SevereFDA (Devices)·Z-2159-2018·2018-06-20

    Maquet Aortic Arterial Cannula Recalled for De-airing Plug Breakage Risk

    Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.

    Product
    Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2188-2018·2018-06-20

    Angiodynamics Recalls XCELA PASV Nitinol Wire Kits Due to Endotoxin Risk

    Angiodynamics Inc. is recalling 7 boxes of XCELA PASV 5F SL 55CM IR-145 Nitinol Wire Kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2146-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 1,742 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2157-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 2 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2220-2018·2018-06-20

    Angiodynamics Recalls Xcela Maximal Barrier Nursing Kits Due to Endotoxins

    Angiodynamics Inc. is recalling Xcela 5FDL-55cm Maximal Barrier Nursing Kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2206-2018·2018-06-20

    Angiodynamics Recalls TANDEM 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling TANDEM 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2219-2018·2018-06-20

    Angiodynamics Recalls CAN 5F Dual Xcela PICC Kits for Endotoxin Risk

    Angiodynamics Inc. is recalling 27 boxes of CAN 5F Dual Xcela PICC kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    CAN 5F DUAL XCELA PICC, Catalog Number 60M701532
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2181-2018·2018-06-20

    Siemens Recalls Dimension Gentamicin Flex Reagent Cartridges Due to Inaccuracy

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Gentamicin Flex reagent cartridges because they may produce inaccurate test results at the low end of the measurement range.

    Product
    Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2018·2018-06-20

    Sun Med STAT-Check Manual Resuscitator Recalled for Port Detachment Risk

    Sun Med, LLC is recalling STAT-Check Manual Resuscitators because the patient port retaining ring may not fully seat, allowing the port to detach and impact air delivery.

    Product
    STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2178-2018·2018-06-20

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope Corporation is recalling 10 units of Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow flow.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2182-2018·2018-06-20

    Siemens Gentamicin Reagent Cartridge Recall Due to Low-End Inaccuracy

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Gentamicin Flex reagent cartridges because they may produce inaccurate results at low concentrations.

    Product
    Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2018·2018-06-20

    Roche cobas e 801 Immunoassay Analyzer Recalled for Plunger Defect

    Roche Diagnostics is recalling 35 cobas e 801 immunoassay analyzers because a tilted syringe plunger may crack, leading to impaired syringe function.

    Product
    cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2060-2018·2018-06-20

    Shimadzu Sonialvision Safire II X-ray System Recalled for Irradiation Display Error

    Shimadzu Medical Systems is recalling 17 Sonialvision Safire II angiographic x-ray systems because the irradiation time and integral dose displays may reset to zero during serial radiography.

    Product
    Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2204-2018·2018-06-20

    Angiodynamics Recalls RS Tandem 5F DL Bioflo Pasv Catheters

    Angiodynamics Inc. is recalling RS Tandem 5F DL Bioflo Pasv catheters because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2215-2018·2018-06-20

    Angiodynamics Recalls RS TANDEM 5F DL BIOFLO PASV Catheters

    Angiodynamics Inc. is recalling 20 boxes of RS TANDEM 5F DL BIOFLO PASV catheters because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2155-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, allowing the port to detach and impact air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2193-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2150-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Retaining Ring Defect

    Sun Med, LLC is recalling 40 cases of Medline Adult Manual Resuscitators because a retaining ring may not seat fully, allowing the patient port to detach and impact air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2179-2018·2018-06-20

    Datascope Recalls Pediatric Cardiopulmonary Bypass Tubing Kits Due to Valve Defect

    Datascope Corporation is recalling 27 pediatric cardiopulmonary bypass tubing kits because the over-pressure safety valve may fail to allow flow.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2177-2018·2018-06-20

    Zimmer Biomet Recalls 75mm Tibial Tray Implants Due to Sizing Error

    Zimmer Biomet is recalling 16 units of 75mm tibial tray implants that may be incorrectly labeled as 79mm. This error could lead to surgical delays or the need for immediate revision surgery.

    Product
    Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2154-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 110 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching the port and impacting air delivery to the patient.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F
    Category
    Medical Device
    Distribution
    2 states