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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4826–4850 of 27364

  • HighFDA (Devices)·Z-2523-2024·2024-08-14

    Biopsy Drape Pack sterilization failure recall from American Contract Systems

    American Contract Systems is recalling 224 Biopsy Drape Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised the sterility of affected units. Lot 981241 distributed in CA, KS, ME, MN, MO, NE, and SD is affected.

    Product
    American Contract Systems Biopsy Drape Pack convenience kit
    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-2528-2024·2024-08-14

    Multitom Rax X-Ray Systems Support Arm May Lower Unexpectedly

    The support arm on Siemens Multitom Rax X-ray systems may unintentionally lower, creating a fall risk to people positioned beneath the ceiling-mounted display during system positioning.

    Product
    Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-2507-2024·2024-08-14

    Integra Recalls TruDi NAV Suction Instruments for Calibration Error

    Integra LifeSciences has recalled 265 TruDi NAV Suction Instruments due to incorrect calibration. The miscalibrated units may display inaccurate position information during surgical navigation procedures.

    Product
    TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-2516-2024·2024-08-14

    Medline Centurion Procedure Kits Recalled for Syringe Leaks, Breakage, and Quality Defects

    Medline has recalled Centurion procedure kits containing syringes affected by an FDA safety alert. The syringes may leak, break, or have other quality defects, posing a risk to patient health.

    Product
    Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2466-2024·2024-08-14

    SIGNA PET/MR diagnostic imaging system poses implant overheating risk

    GE HealthCare recalled SIGNA PET/MR systems with specific software versions due to a configuration issue that can cause RF energy to exceed safety limits, potentially overheating MR-conditional implants.

    Product
    SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2511-2024·2024-08-14

    Philips IntelliVue Patient Monitors Shipped with Missing Monitoring Capabilities

    Philips IntelliVue patient monitors shipped or updated with software that removes monitoring capabilities, potentially delaying or resulting in incorrect treatment.

    Product
    IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. 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-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-2525-2024·2024-08-14

    Siemens x-ray display system support arm may lower unexpectedly

    Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.

    Product
    Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2024·2024-08-14

    Surgical Convenience Kits Recalled for Potential Sterilization Failure

    American Contract Systems is recalling three surgical convenience kits due to potential sterilization failure from insufficient aeration time during processing.

    Product
    American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
    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-2485-2024·2024-08-14

    Automated medication cabinet software prints incorrect bin labels

    The BD PYXIS MEDBANK MINI automated dispensing cabinet software may print incorrect bin locations on restock labels, potentially causing medications to be placed in wrong locations.

    Product
    BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
    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-2493-2024·2024-08-14

    Medication dispensing cabinet software issue causes incorrect medication bin labels

    A software issue in BD PYXIS MEDBANK automated medication dispensing cabinets can cause incorrect medication bin labels on restock labels, potentially leading to medication storage errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-2524-2024·2024-08-14

    American Contract Systems Spine Pack kits recalled for insufficient sterilization aeration

    American Contract Systems is recalling Spine Pack convenience kits (Lot 980241) due to incomplete post-sterilization aeration. The affected kits were distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.

    Product
    American Contract Systems Spine Pack convenience kit
    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-2459-2024·2024-08-14

    SIGNA Architect MRI System Software Can Exceed Implant Heating Limits

    GE Medical Systems is recalling SIGNA Architect MRI systems in which software may allow B1+ radiofrequency exposure to exceed user-prescribed limits during certain T2 FLAIR imaging sequences, risking MR-conditional implant overheating.

    Product
    SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, 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-2450-2024·2024-08-07

    Hip Replacement Prosthesis Recalled Due to Increased Postoperative Fracture Risk

    Zimmer hip replacement prostheses are recalled due to increased risk of postoperative femoral fracture. Affected devices are distributed nationwide; patients should consult their surgeon.

    Product
    CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 008114
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2457-2024·2024-08-07

    Arctic Sun Temperature Management System software failure may disable critical safety alarms

    Arctic Sun Temperature Management Systems may fail to reach target temperature and critically fail to alert clinicians. The software defect affects approximately 10,507 units worldwide and risks hypothermia or hyperthermia.

    Product
    Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2455-2024·2024-08-07

    Clinical Chemistry Analyzer Software Bugs May Cause Erroneous Patient Results

    Beckman Coulter's DxC 500 AU analyzer has two software bugs that may cause erroneous patient results due to misreported calibrations or expired reagents. No injuries or illnesses have been reported.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide