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 13816

  • 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-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-0776-2022·2022-03-23

    Medical Device Sterile Barrier Breach: JAGTOME RX Recall

    Boston Scientific is recalling JAGTOME RX medical devices because the sterile barrier may be compromised, which could allow contamination. The recall affects 163 units distributed worldwide.

    Product
    JAGTOME RX 44-30-450-035 Material Number: M00573070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2022·2022-03-23

    Boston Scientific JAGTOME RX Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 96 units of JAGTOME RX medical devices due to a sterile barrier breach that compromises device sterility. Patients should contact their physician if they received this device.

    Product
    JAGTOME RX 49-30-260-035 Material Number: M00573020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-0790-2022·2022-03-23

    FDA Recalls Safe-T PLUS Pediatric Lumbar Puncture Tray Due to Manometer Failure

    Bard Peripheral Vascular Inc is recalling 20,400 Safe-T PLUS pediatric lumbar puncture trays due to manometer leaking and mating failures. The devices were distributed nationwide and internationally to healthcare facilities.

    Product
    Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
    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-0768-2022·2022-03-23

    Sterile Barrier Breach in JAGTOME RX Medical Devices Worldwide

    Boston Scientific is recalling 4,487 JAGTOME RX medical devices worldwide due to sterility compromise from a sterile barrier breach. Users face contamination risk if devices are used.

    Product
    JAGTOME RX 39-20-260-025 Material Number: M00573080
    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-0795-2022·2022-03-23

    Lumbar Puncture Tray Adult recalled due to manometer failure and leaking

    Bard Peripheral Vascular Inc is recalling 8,630 lumbar puncture trays due to manometer failure causing leaking and mating issues. Devices were distributed nationwide in the U.S. plus Puerto Rico, Costa Rica, and Hong Kong.

    Product
    LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
    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-0769-2022·2022-03-23

    JAGTOME RX medical device recalled for sterile barrier breach

    Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.

    Product
    JAGTOME RX 39-20-450-025 Material Number: M00573090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2022·2022-03-23

    Boston Scientific JAGTOME RX device recalled for sterile barrier breach

    Boston Scientific has recalled 2209 units of the JAGTOME RX medical device worldwide due to compromised sterility from a sterile barrier breach. The affected units were distributed across the US and more than 40 countries.

    Product
    JAGTOME RX 44-30-260-035 Material Number: M00573060
    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-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-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-0770-2022·2022-03-23

    Boston Scientific JAGTOME RX medical device recalled for sterile barrier breach

    Boston Scientific has recalled 1,447 units of the JAGTOME RX 39-30-260-025 medical device due to a compromised sterile barrier that affects device sterility. The affected devices were distributed worldwide.

    Product
    JAGTOME RX 39-30-260-025 Material Number: M00573100
    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-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-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-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-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