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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12076–12100 of 13802

  • 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-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-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-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-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-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-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-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-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-0766-2022·2022-03-23

    Boston Scientific recalls 68 medical devices with sterility breach

    Boston Scientific is recalling 68 JAGTOME REVOLUTION RX medical devices due to sterile barrier breach. The devices were distributed worldwide including throughout the US.

    Product
    JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
    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-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-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-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-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-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-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-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-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-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-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-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-0800-2022·2022-03-23

    SAFE-T PLUS Adult Lumbar Puncture Tray recalled for manometer failure

    Bard Peripheral Vascular Inc recalled 3,240 SAFE-T PLUS Adult lumbar puncture trays due to manometer failures involving leaking and defective mating connections.

    Product
    SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2022·2022-03-23

    Hologic Panther Fusion Extraction Reagent-X May Produce False Test Results

    Hologic is recalling Panther Fusion Extraction Reagent-X kits due to failed stability specifications that may cause false negative test results. Healthcare providers should stop using affected lots.

    Product
    Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide