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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5651–5675 of 13543

  • HighFDA (Devices)·Z-2487-2024·2024-08-14

    BD PYXIS medication cabinet software error causes incorrect bin labels

    A software issue in the BD PYXIS MDBNK medication dispensing cabinet may cause restock labels to print with incorrect bin locations, potentially affecting medication storage accuracy.

    Product
    BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2461-2024·2024-08-14

    MRI System Software Miscalculation May Overheat Patient Implants

    A software error in GE SIGNA Hero MRI systems can cause overheating of MR conditional implants under specific conditions. The recall affects 95 units distributed worldwide.

    Product
    SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2499-2024·2024-08-14

    Automated Medication Dispenser Software Bug Causes Incorrect Bin Labels

    BD PYXIS MEDBANK automated medication dispensers may print incorrect medication bin labels due to a software defect, risking medication handling errors in healthcare settings.

    Product
    BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2024·2024-08-14

    GE Brivo MR355 MRI System Software Issue Causing Implant Overheating Risk

    GE HealthCare has recalled certain Brivo MR355 MRI systems due to a software issue that can cause overheating of implanted medical devices in specific imaging scenarios. Approximately 375 units have been affected worldwide.

    Product
    Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2480-2024·2024-08-14

    MRI System Software Issue Can Overheat Implanted Medical Devices

    GE HealthCare recalled 23 SIGNA Victor MRI systems due to a software issue that can cause MR conditional implants to overheat. The defect occurs under specific imaging mode and configuration combinations.

    Product
    SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2495-2024·2024-08-14

    BD PYXIS Medication Cabinet Software Defect Causes Incorrect Restock Labels

    A software issue in BD PYXIS automated medication dispensing cabinets can cause restock labels to print with incorrect bin numbers. Four units are affected nationwide.

    Product
    BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2024·2024-08-14

    American Contract Systems surgical kits recalled for sterilization defect

    American Contract Systems Laparoscopy and Lap Chole surgical kits are being recalled because insufficient aeration time after sterilization may have compromised their sterility. The kits were distributed in seven U.S. states.

    Product
    American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2024·2024-08-14

    Automated dispensing cabinet software issue causes incorrect medication bin labels

    CareFusion is recalling 232 automated medication dispensing cabinets due to a software issue that may print incorrect medication bin labels, potentially causing medication dispensing errors.

    Product
    BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2024·2024-08-14

    Medical Procedure Kit Recalled Over Potential Sterilization Compromise

    American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.

    Product
    American Contract Systems Special Procedure Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2024·2024-08-14

    Everest Bipolar Cutting Forceps Recalled for Potential Sterility Breach

    Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may result in a sterility breach. Approximately 6985 units are affected and were distributed worldwide.

    Product
    The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2024·2024-08-14

    GE Discovery MR750w MRI System Software May Overheat Implants

    GE HealthCare is recalling certain Discovery MR750w 3.0T MRI systems where the magnetic field strength (B1+RMS) can exceed the prescribed limit during specific imaging sequences, potentially causing overheating of MR-conditional implants.

    Product
    Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2494-2024·2024-08-14

    Medication Dispensing Cabinet Software Defect Causes Incorrect Bin Labels

    BD PYXIS automated medication dispensing cabinets contain a software issue that may print incorrect bin locations on restock labels. This could result in medications being placed in the wrong bin during restocking.

    Product
    BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2024·2024-08-14

    GE MR450w 1.5T MRI software defect may cause implant overheating

    GE MR450w 1.5T MRI systems may overheat MR-conditional implants when using specific imaging sequences with Low SAR Mode. No injuries reported; 1,607 units affected worldwide.

    Product
    Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2534-2024·2024-08-14

    Philips Azurion X-ray System: Potential Loss of Imaging Functionality

    The Philips Azurion Interventional Fluoroscopic X-ray System may lose imaging functionality or experience longer restart times. The FDA is recalling approximately 3,011 units of this device worldwide.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2024·2024-08-14

    Automated Medication Dispensing Cabinet Software Issue with Incorrect Bin Labeling

    BD PYXIS MEDBANK automated medication dispensing cabinets with software version 3.9.1.9 may generate incorrect bin location labels during restocking. This could cause medications to be placed in wrong storage locations.

    Product
    BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2024·2024-08-14

    MRI System Software Error Can Overheat Patient Implants

    GE Medical Systems recalled three SIGNA 7.0T MRI systems due to a software error that can exceed preset safety limits during imaging, potentially overheating implants in patients under certain conditions.

    Product
    SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2539-2024·2024-08-14

    Medical Device Hookup Instructions Contain Errors Affecting Endoscope Disinfection

    Steris Corporation recalls certain automated endoscope reprocessor hookups due to incorrect instructions in product documentation. Improper hookup connection could prevent proper endoscope disinfection, risking patient infection.

    Product
    Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexib
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2024·2024-08-14

    GE SIGNA MR355 MRI System Recalled for Potential Implant Overheating Risk

    GE SIGNA MR355 MRI systems running software versions SV25.5 or SV25.6 may cause implant overheating in certain scanning conditions. Risk occurs when using specific imaging sequences with the Optimized T2 FLAIR feature disabled.

    Product
    SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2508-2024·2024-08-14

    Philips IntelliVue Patient Monitor Software Missing Critical Entitlements

    Philips IntelliVue Patient Monitor models with software L.x and M.x lack critical monitoring capabilities due to a software update. This could result in incorrect or delayed patient treatment.

    Product
    IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2024·2024-08-14

    BD PYXIS MEDBANK Automated Cabinet May Print Incorrect Medication Bin Labels

    A software issue in the BD PYXIS MEDBANK automated medication dispensing cabinet can cause incorrect bin labels to be printed for restock operations. This could lead to medication administration errors affecting patient safety.

    Product
    BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2514-2024·2024-08-14

    Diagnostic Test Kits Recalled for False Vibrio Results With Certain Transport Medium

    BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.

    Product
    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnost
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2491-2024·2024-08-14

    BD PYXIS MEDBANK Cabinet Software Causes Incorrect Medication Labels

    FDA recall of BD PYXIS MEDBANK automated medication dispensing cabinets due to a software defect that prints incorrect bin information on restock labels, potentially leading to medication identification errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2024·2024-08-14

    GE SIGNA Prime MR system can exceed RF safety limits in Low SAR mode

    GE Medical Systems is recalling 72 SIGNA Prime MR imaging systems worldwide. Under specific imaging conditions, the systems can exceed prescribed radiofrequency safety limits, potentially causing MR conditional implants to overheat.

    Product
    SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2462-2024·2024-08-14

    GE SIGNA Premier MRI system software overheating risk to implants

    GE Medical Systems is recalling 404 SIGNA Premier MRI systems worldwide due to a software issue where radiofrequency energy can exceed prescribed safety limits during specific imaging sequences, potentially overheating MR-conditional implants.

    Product
    SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2509-2024·2024-08-14

    Philips IntelliVue Patient Monitors with disabled monitoring software options

    Philips IntelliVue Patient Monitors (MX400/450/500/550) with software versions L.x or M.x lack required monitoring capabilities due to removed software entitlements. The missing features could lead to incorrect or delayed patient treatment.

    Product
    IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, an
    Category
    Medical Device
    Distribution
    Distributed nationwide