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.

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2551–2575 of 13381

  • HighFDA (Devices)·Z-2316-2025·2025-08-20

    GE MRI Systems May Have Missed Planned Caster Lock Maintenance

    GE HealthCare is recalling certain MRI systems where planned maintenance checks of patient table caster locks may not have been performed. Patients should contact GE or their healthcare facility about past procedures on affected systems.

    Product
    GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2292-2025·2025-08-20

    Bartels ELISA Legionella Urinary Antigen diagnostic test kits recalled for particulate contamination

    Trinity Biotech USA recalls Bartels ELISA Legionella Urinary Antigen diagnostic test kits due to potential particulate matter contamination. Approximately 968 kits in lot numbers 065 and 066 were distributed in the United States and internationally.

    Product
    Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2025·2025-08-20

    LMW Heparin Controls not meeting quality acceptance specifications

    Instrumentation Laboratory is recalling HemosIL LMW Heparin Controls due to lower than expected quality control results. Some units fall below acceptance specifications, delaying laboratory patient testing procedures.

    Product
    HemosIL LMW Heparin Controls; Part Number: 0020300200;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2025·2025-08-20

    Pulsed Field Ablation Catheter Recalled Due to Electrode Band Defects

    Boston Scientific is recalling 445 FARAWAVE 1.0 Pulsed Field Ablation Catheter units nationwide due to potential cracks in electrode bands caused by manufacturing equipment.

    Product
    FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2025·2025-08-20

    MR Imaging System Caster Lock Maintenance May Not Have Been Performed

    GE HealthCare recalls certain MR imaging systems where planned maintenance checks on patient table caster locks may not have been performed. The recall affects systems that received maintenance since March 1, 2023.

    Product
    GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2283-2025·2025-08-20

    Carefree Kittner Rolls Surgical Gauze Recalled for Contamination and Incorrect Quantity

    Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Rolls Gauze due to biological contamination that could compromise sterility and incorrect quantities in sterile packaging.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2319-2025·2025-08-20

    GE SIGNA MRI Patient Table Caster Lock Maintenance Alert

    GE HealthCare is recalling SIGNA MRI systems because maintenance checks on patient table caster locks may not have been completed on systems serviced since March 2023. Operators should verify their system's maintenance status.

    Product
    GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2309-2025·2025-08-20

    GE Medical MR Systems Patient Table Caster Locks May Not Have Been Checked

    GE HealthCare is recalling 97 MR imaging systems worldwide because planned maintenance checks on patient table caster locks may not have been performed. Affected units include multiple SIGNA model variants used in medical imaging facilities.

    Product
    GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2281-2025·2025-08-20

    [pending] Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4

    Pending LLM rewrite. Source: FDA_DEVICE Z-2281-2025.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2025·2025-08-20

    Carefree Surgical Robotic Laparoscopy Kittner Gauze Recalled for Contamination

    Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Roll Gauze due to biological contamination that could compromise sterility and incorrect quantity in sterile packaging.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2025·2025-08-20

    [pending] Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Versi

    Pending LLM rewrite. Source: FDA_DEVICE Z-2291-2025.

    Product
    Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2321-2025·2025-08-20

    BD PYXIS MEDBANK Automated Dispensing Cabinets: Delayed Medication Access Risk

    Automated medication dispensing cabinets may delay access to medications due to a workflow defect in the override/Add Item function. The issue affects healthcare facilities nationwide.

    Product
    Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-
    Category
    Medical Device
    Distribution
    Distributed nationwide