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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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7951–7975 of 13652

  • HighFDA (Devices)·Z-0291-2024·2023-11-22

    Atrium Advanta V12 Covered Stent System Recalled for Weld Failure

    Atrium Medical Corporation is recalling 141 units of the Advanta V12 Covered Stent System due to a balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Affected units were distributed to eleven countries.

    Product
    Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indicat
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0305-2024·2023-11-22

    Defibrillator battery pins may loosen, affecting power

    Physio-Control LIFEPAK 15 defibrillators (serial numbers 48433670 and 48744028) may experience battery pin loosening, potentially causing power issues. Two units were distributed in AZ, CA, NC, NJ, and NY.

    Product
    LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2024·2023-11-22

    Philips Big Bore RT CT Scanner Defect May Cause Incorrect Treatment Planning

    A software defect in Philips Big Bore RT CT scanners may cause incorrect coordinates in radiation therapy planning systems, affecting 56 units distributed nationwide and internationally.

    Product
    Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could cause power failure. Four affected units have been distributed to Arizona, California, North Carolina, New Jersey, and New York.

    Product
    LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2024·2023-11-22

    Blood Culture Kits Recalled Due to Expired Internal Components

    Medline Industries is recalling 3,160 units of 24 Blood Culture Kits because components within the kit have expired before the overall kit's stated expiration date. Expired components may compromise device performance or test result accuracy.

    Product
    24 BLOOD CULTURE KIT, REF DYNDH1632
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0297-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could result in power loss. Affected devices were distributed in AZ, CA, NC, NJ, and NY.

    Product
    LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2024·2023-11-22

    IBA Proton Therapy System Patient Positioning Can Move Unexpectedly

    The IBA Proton Therapy System's patient positioning system can perform unexpected motions, risking patient crushing. Five US units and nine international units are affected.

    Product
    IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2024·2023-11-22

    Medical Device Recall: KWIKSTIK Microbiological Reagent Contaminated with Aspergillus

    Microbiologics Inc recalls KWIKSTIK microbiological reagent kits due to Aspergillus flavus contamination in bulk pellets. Affected products were distributed worldwide, including the US, Italy, France, Turkey, Peru, and Mexico.

    Product
    KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2024·2023-11-22

    Medical Device Reagent Recalled for Unreliable Test Results

    Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.

    Product
    AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0299-2024·2023-11-22

    LIFEPAK 15 defibrillator recalled for potential battery power loss

    Physio-Control is recalling 5 LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, resulting in power loss. No illnesses or injuries have been reported.

    Product
    LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0310-2024·2023-11-22

    Medline Blood Culture Collection Kits Recalled for Expired Internal Components

    Medline is recalling 4,850 adult blood culture collection kits (lot numbers 23EMI373, 23EMF712, 23DMF155, 23CMH026) because components inside expired before the kit's labeled expiration date.

    Product
    ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0318-2024·2023-11-22

    Express Dry Seal Chest Drains Recalled for Insufficient Setup Instructions

    Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N) due to inadequate instructions for proper catheter and patient tube connection setup. No injuries have been reported.

    Product
    Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0294-2024·2023-11-22

    CT Scanner Image Fusion Software Error Affecting Radiation Therapy Planning

    A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.

    Product
    Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0300-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins Risk Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, causing power issues.

    Product
    LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0298-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Failure

    Physio-Control is recalling LIFEPAK 15 defibrillators due to loose battery pins that may cause power failure. Users should verify device functionality immediately.

    Product
    LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0303-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

    Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.

    Product
    LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2024·2023-11-22

    LIFEPAK 15 Defibrillators Recalled Due to Potential Loose Battery Pins

    Physio-Control has recalled LIFEPAK 15 defibrillators because battery pins may become loose, causing power issues. Owners should contact the manufacturer for instructions on how to proceed.

    Product
    LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2024·2023-11-22

    Ocean Chest Drains Recalled for Inadequate Assembly Instructions

    Atrium Medical recalls Ocean chest drains due to insufficient precaution instructions for proper catheter and tube connection setup. Improper assembly could compromise device function.

    Product
    Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0296-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall for Battery Pin Loosening

    Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (Part Number V15-2-000051) because battery pins may loosen and cause power failure. Affected devices should not be used until repaired.

    Product
    LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential for battery pins to become loose, which could cause power failure.

    Product
    LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0223-2024·2023-11-22

    Siemens Mobilett Mira wireless x-ray systems recalled for buzzer mounting defect

    Four Siemens Mobilett Mira wireless mobile x-ray systems are recalled due to incorrect buzzer component mounting that prevents acoustic signals during x-ray activation. The systems remain fully functional with visual LED indicators available for operator monitoring.

    Product
    Mobilett Mira wireless (VA20) mobile x-ray system(s)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0286-2024·2023-11-15

    Cordis Cardiac Catheter Sets Distributed Non-Sterile, Labeled Sterile

    Cordis US Corp is recalling cardiac catheter sets (Lot 18223410) distributed in Oklahoma. The devices were non-sterile but labeled as sterile, creating infection risk to patients.

    Product
    Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0191-2024·2023-11-15

    Olympus Bronchovideoscope Recalled for Fire Risk During Cauterization

    Olympus Corporation recalls 13,950 EVIS EXERA II bronchovideoscopes due to risk of endobronchial combustion when high-frequency cauterization is performed with oxygen supplied while the electrode is positioned too close to the endoscope.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0188-2024·2023-11-15

    StealthStation S8 Surgical Navigation System Software Anomaly Recall

    Medtronic is recalling StealthStation S8 and FlexENT systems with software versions 2.0 and 2.0.1 due to a software anomaly that could cause surgical planning data to shift to an unintended location.

    Product
    StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT
    Category
    Medical Device
    Distribution
    Distributed nationwide