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.

Filters

Agency

Category

Minimum severity

Clear filters

12101–12125 of 13837

  • ModerateFDA (Devices)·Z-0824-2022·2022-03-30

    Cytocell Microscope Slides Recall: Incorrect Expiry Date on Label

    Cytocell Ltd. is recalling Cytocell 8 Square Template Slides because the outer label displays an incorrect expiration date of 2023-05 when the actual validated shelf life expires 2022-02.

    Product
    Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0719-2022·2022-03-23

    Unauthorized COVID-19 Diagnostic Test Kits Imported Without FDA Approval

    SD Biosensor's STANDARD Q COVID-19 Ag Home Test kits were illegally imported without FDA approval, clearance, or authorization. Approximately 400,000 units were distributed nationwide.

    Product
    STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2022·2022-03-23

    Medical device sterile barrier breach in Boston Scientific HYDRATOME RX

    Boston Scientific is recalling HYDRATOME RX 49-30MM/260CM devices worldwide because sterile barriers are compromised. The manufacturing defect affects device sterility.

    Product
    HYDRATOME RX 49-30MM/260CM Material Number: M00583010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2022·2022-03-23

    DREAMTOME Medical Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 32 units of DREAMTOME endoscopic devices due to a sterile barrier breach that compromises device sterility, creating potential infection risk. No illnesses have been reported.

    Product
    DREAMTOME 49-30MM/450CM Material Number: M00584030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2022·2022-03-23

    Boston Scientific Medical Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 3,330 units of JAGTOME REVOLUTION RX devices due to a sterile barrier breach that compromises device sterility. The devices were distributed worldwide.

    Product
    JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0789-2022·2022-03-23

    SAM CHEST SEAL devices recalled due to assembly defect preventing wound seal

    Sam Medical Products is recalling 2,950 packages of SAM CHEST SEAL (Model CS203-EN, Lot Y060321-09) with defective dressing containing holes that prevent creating an occlusive seal for chest wounds.

    Product
    SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0794-2022·2022-03-23

    FDA Recalls SAFE-T PLUS Lumbar Puncture Trays for Device Malfunction

    Bard Peripheral Vascular is recalling 49,760 SAFE-T PLUS lumbar puncture trays for adults due to manometer leaking and mating issues. Healthcare providers should discontinue use and contact the manufacturer.

    Product
    SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2022·2022-03-23

    Lumbar Puncture Tray Recalled for Manometer Leaking and Connection Issues

    Bard Peripheral Vascular is recalling 29,870 lumbar puncture trays due to manometer failure that causes leaking and improper connections. The defect could compromise device function during lumbar puncture procedures.

    Product
    LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2022·2022-03-23

    Syphilis Test Reagent Pack Recalled for Vaccine Interference and Manufacturing Defects

    Bio-Rad's BioPlex 2200 Syphilis Test Reagent Pack is being recalled due to concerns that COVID-19 vaccines may interfere with test results, and due to manufacturing defects affecting reagent stability.

    Product
    BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
    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-0749-2022·2022-03-23

    Abbott Alinity s System software error affects diagnostic analyzer wash cycle

    Abbott Laboratories is recalling 306 units of Alinity s System software version 2.8.0 due to a software error causing insufficient wash buffer volume, which could affect diagnostic test accuracy.

    Product
    Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specifi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0763-2022·2022-03-23

    Sterile barrier breach recalled in Boston Scientific HYDRATOME RX catheters

    Boston Scientific is recalling HYDRATOME RX catheters due to sterile barrier compromise. The 112 affected units worldwide may pose infection risk if used.

    Product
    HYDRATOME RX 49-20MM/260CM Material Number: M00583000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2022·2022-03-23

    Wright Medical ORTHOLOC Surgical Screw Recalled for Incorrect Component Packaging

    Wright Medical Technology's ORTHOLOC Non-Locking Screw was recalled due to a packaging error in lot #73967511638696, where locking screws were mistakenly packaged instead. The affected product was distributed to France.

    Product
    Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-0748-2022·2022-03-23

    Diagnostic ultrasound system ACUSON Juniper fails to save study clips

    The ACUSON Juniper ultrasound system's clip storage function fails when the disk is full, potentially delaying treatment during critical imaging procedures. Healthcare facilities using this system should contact Siemens for support.

    Product
    Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneolo
    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-0760-2022·2022-03-23

    Hydratome RX 44-20MM medical device recalled for sterile barrier breach

    Boston Scientific is recalling 254 units of the Hydratome RX 44-20MM medical device worldwide due to a compromised sterile barrier that may affect device sterility.

    Product
    HYDRATOME RX 44-20MM/450CM Material Number: M00583060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0792-2022·2022-03-23

    FDA Recalls Adult Lumbar Puncture Trays for Manometer and Connector Defects

    Bard Peripheral Vascular is recalling 116,770 adult lumbar puncture trays due to manometer leaks and connector mating defects that could affect procedure performance.

    Product
    LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
    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-0756-2022·2022-03-23

    DREAMTOME medical device recall: sterility compromised by barrier breach

    Fifteen Boston Scientific DREAMTOME medical devices are being recalled due to a sterile barrier breach that compromises device sterility. The affected lot number 27802363 requires appropriate action.

    Product
    DREAMTOME 49-20MM/450CM Material Number: M00584020
    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-0759-2022·2022-03-23

    Boston Scientific HYDRATOME RX Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 7,695 units of HYDRATOME RX devices worldwide due to compromised sterility from a sterile barrier breach. Affected devices may pose a risk of infection.

    Product
    HYDRATOME RX 44-20MM/260CM Material Number: M00583040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2022·2022-03-23

    Lumbar Puncture Trays Recalled for Manometer Leaking and Assembly Defects

    Bard Peripheral Vascular Inc. is recalling 2,880 Lumbar Puncture Drug Free Trays due to defects in the manometer component involving leaking and mating issues that could affect device function.

    Product
    LUMBAR PUNCTURE DRUG FREE TRAY 22G
    Category
    Medical Device
    Distribution
    Distributed nationwide