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 deaths or serious injuries are reported, 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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12101–12125 of 13802

  • HighFDA (Devices)·Z-0781-2022·2022-03-23

    Boston Scientific RX Cholangiogram Kit Recall Due to Sterile Barrier Breach

    Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.

    Product
    RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0762-2022·2022-03-23

    HYDRATOME RX surgical device recalled due to sterile barrier breach

    Boston Scientific recalls 251 HYDRATOME RX 44-30MM/450CM units worldwide due to sterile barrier breach that compromises device sterility.

    Product
    HYDRATOME RX 44-30MM/450CM Material Number: M00583070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2022·2022-03-23

    Boston Scientific JAGTOME RX Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 14 JAGTOME RX medical devices worldwide due to a sterile barrier breach that compromises the device's sterility.

    Product
    JAGTOME RX 49-30-450-035 Material Number: M00573030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2022·2022-03-23

    Boston Scientific DREAMTOME Medical Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 142 units of DREAMTOME 44-30MM/450CM medical devices distributed worldwide due to a sterile barrier breach that compromises device sterility. Affected lot numbers are 27625066 and 27805561.

    Product
    DREAMTOME 44-30MM/450CM Material Number: M00584070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2022·2022-03-23

    Lumbar Puncture Tray Pediatric Recalled Due to Manometer Failure

    Bard Peripheral Vascular Inc is recalling pediatric lumbar puncture trays due to manometer leaking and mating failures that could prevent proper pressure measurement during procedures.

    Product
    LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2022·2022-03-23

    Medical Device Recall: Boston Scientific JAGTOME RX Sterile Barrier Breach

    Boston Scientific is recalling 98 units of the JAGTOME RX 39-30-260-025 medical device due to compromised sterile barrier that affects device sterility. Units were distributed worldwide.

    Product
    JAGTOME RX 39-30-260-025 Material Number: M00573100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2022·2022-03-23

    RX CHOLANGIOGRAM KIT recalled due to sterile barrier breach

    Boston Scientific is recalling RX CHOLANGIOGRAM KIT due to a sterile barrier breach that compromises device sterility. Approximately 500 units distributed worldwide are affected.

    Product
    RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2022·2022-03-23

    Boston Scientific DREAMTOME device recalled due to sterile barrier breach

    Boston Scientific is recalling 12,067 DREAMTOME devices worldwide due to compromised sterility from a sterile barrier breach. The affected units may not be properly protected from contamination.

    Product
    DREAMTOME 44-30MM/260CM Material Number: M00584050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0761-2022·2022-03-23

    Boston Scientific Hydratome RX Devices Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling Hydratome RX 44-30MM/260CM devices due to a sterile barrier breach that could compromise device sterility. The recall affects 3,371 units distributed worldwide.

    Product
    HYDRATOME RX 44-30MM/260CM Material Number: M00583050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2022·2022-03-23

    Medical Device Sterility Compromise Recall by Boston Scientific

    Boston Scientific has recalled 3,578 units of the JAGTOME RX medical device due to sterility compromise from a barrier breach. Affected units were distributed worldwide.

    Product
    JAGTOME RX 44-20-260-035 Material Number: M00573040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2022·2022-03-23

    Boston Scientific Sphincterotome Recalled for Sterile Barrier Breach

    Boston Scientific Corporation is recalling 1,811 units of Dreamtome Cannulating Sphincterotomes worldwide because the sterile barrier is compromised, creating a potential contamination risk.

    Product
    Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2022·2022-03-23

    LINQ II Insertable Cardiac Monitor Recalled for Moisture Ingress

    Medtronic is recalling 8 LINQ II Insertable Cardiac Monitors due to moisture ingress susceptibility that may cause loss of functionality. Affected devices were distributed in the US (NJ, NY, PA, VA) and Italy.

    Product
    LINQ II Insertable Cardiac Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2022·2022-03-23

    Boston Scientific JAGTOME RX Medical Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 101 units of JAGTOME RX devices due to compromised sterile barriers that could allow contamination and infection. The recall affects devices distributed worldwide.

    Product
    JAGTOME RX 49-20-260-035 Material Number: M00573000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2022·2022-03-23

    BioPlex 2200 Syphilis Calibrator Set Recall Due to Vaccine Interference and Reagent Stability Issues

    Bio-Rad Laboratories is recalling 724 BioPlex 2200 Syphilis Calibrator sets due to COVID-19 vaccine interference concerns and manufacturing problems with reagent stability. The recalled lots were distributed nationwide in the U.S. and internationally.

    Product
    BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0751-2022·2022-03-23

    Boston Scientific Sphincterotome Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 21,309 units of the Dreamtome RX Cannulating Sphincterotome due to a sterile barrier breach that compromises device sterility, creating a potential infection risk to patients.

    Product
    Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2022·2022-03-23

    Traverse Rail Carrier E-System components with defective short screws

    Hill-Rom Traverse Rail Carrier E-System components contain non-conforming screws that are too short to secure the rail properly. The screws could loosen over time, causing the rail system to fall and potentially injure caregivers or patients.

    Product
    (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2022·2022-03-23

    Medical Device JAGTOME RX Recalled for Compromised Sterile Barrier

    Boston Scientific is recalling 3,578 units of the JAGTOME RX medical device because the sterile barrier is compromised, which can allow contamination. The affected units were distributed worldwide.

    Product
    JAGTOME RX 44-20-450-035 Material Number: M00573050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2022·2022-03-23

    Boston Scientific DREAMTOME Stent Devices Recalled for Sterility Compromise

    Boston Scientific is recalling 472 DREAMTOME stent devices due to sterile barrier breach affecting product sterility. Devices were distributed worldwide including the US.

    Product
    DREAMTOME 49-30MM/260CM Material Number: M00584010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2022·2022-03-23

    GE CARESCAPE Central Station audio alarms may be muted with unapproved keyboard

    GE Healthcare is recalling 10,445 CARESCAPE Central Station monitoring systems. If connected to an unapproved keyboard, audio alarms may be muted, potentially preventing users from receiving critical notifications.

    Product
    GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0805-2022·2022-03-23

    Calcium Alginate Wound Dressings Recalled for Incorrect Instructions

    CellEra LLC is recalling Vitale Silver calcium alginate dressings nationwide because packages contain incorrect Instructions for Use with language not approved by the FDA. The firm is providing replacement packages with corrected instructions.

    Product
    20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0784-2022·2022-03-23

    Mycoplasma genitalium Control Panel Distributed Without Proper Release Testing

    Microbiologics Inc is recalling Mycoplasma genitalium Control Panel units that did not undergo proper release testing before distribution. Affected lots were distributed across the U.S. and internationally.

    Product
    Mycoplasma genitalium Control Panel (Inactivated Pellet)
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0787-2022·2022-03-23

    Sorin Centrifugal Pump CP5 Drive Unit missing electromagnetic shielding component

    LivaNova is recalling four Sorin Centrifugal Pump CP5 Drive Units because a ferrite ring on the power cable may be missing. The units were distributed in Florida, Texas, and Nebraska.

    Product
    Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0788-2022·2022-03-23

    LYFO Disk Quality Control Product Recalled for Organism Mislabeling

    Microbiologics Inc recalls LYFO Disk lot 983-40-3 because it is labeled as Candida tropicalis but actually contains Yersinia enterocolitica. The mislabeling may cause laboratory quality control failures and delayed test results.

    Product
    LYFO Disk
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0802-2022·2022-03-23

    Calcium Alginate Wound Dressings Recalled for Incorrect Instructions

    CellEra LLC is recalling Vitale Silver calcium alginate wound dressings nationwide due to incorrect instructions for use containing language beyond FDA-cleared content.

    Product
    20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
    Category
    Medical Device
    Distribution
    Distributed nationwide