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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Minimum severity

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

Clear filters

8651–8675 of 40056

  • HighFDA (Devices)·Z-0504-2024·2023-12-13

    Medical Catheter Sets Recalled Due to Bonding Material Defect

    CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.

    Product
    CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2024·2023-12-13

    Automated Impella Controller Software Issue Prevents Pump Detection

    Abiomed is recalling Automated Impella Controller (AIC) software versions V8.4 and V8.4.1 due to a software issue that may prevent the pump from being detected as connected to the controller. Devices were distributed in Arizona, California, Florida, New York, and Virginia.

    Product
    Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0435-2024·2023-12-13

    ProCurity hospital beds recalled for missing electrical safety testing

    Stryker is recalling ProCurity model 3009 patient beds because they lack required electrical safety testing, creating a risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.

    Product
    ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2024·2023-12-13

    HVAD Ventricular Assist Device Updated Instructions for Alarm Conditions

    Heartware is providing updated instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and device useful life information for 892 implanted units worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0455-2024·2023-12-13

    NovoTHOR Gen 2.5 Therapy Bed Recalled for Ball Stud Failure

    Thor Photomedicine's NovoTHOR Gen 2.5 therapy beds are being recalled due to failure of ball stud components in the gas strut, which can detach from the canopy. This affects 26 units distributed across the US and internationally.

    Product
    NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2024·2023-12-13

    Integra Cranial Access Kit Recalled for Packaging Defect Compromising Sterility

    Integra LifeSciences is recalling 510 units of Cranial Access Kits due to a defect in outer packaging that can split spontaneously, compromising device sterility and increasing infection risk in neurosurgery.

    Product
    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2024·2023-12-13

    ProCuity Patient Beds Recalled for Missing Electrical Safety Tests

    Stryker Medical is recalling ProCuity bed series model 3009 due to missing electrical safety test values. The beds pose a risk of electrical shock or tissue burn to patients.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-L-100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2024·2023-12-13

    ProCuity Hospital Beds Missing Electrical Safety Test Data

    Stryker's ProCuity bed series model 3009 lacks required electrical safety test documentation, creating a risk of tissue burns or electrical shock. The beds are distributed across North America, Europe, and other regions.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-L-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2024·2023-12-13

    Medical Radiation Therapy Device Microswitch May Cause Uncontrolled Detector Arm Extension

    Elekta radiation therapy accelerators may experience uncontrolled detector arm extension due to an incorrectly set microswitch in the middle arm. The issue affects 315 units worldwide.

    Product
    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0478-2024·2023-12-13

    Medical Device Instruction Update: HVAD Ventricular Assist Device Clarifications

    HeartWare is issuing clarifications to instructions for the PUMP 1103 HVAD ventricular assist device regarding when Controller Fault alarms sound and component useful life. No illnesses or injuries have been reported.

    Product
    PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0446-2024·2023-12-13

    Medical radiation therapy system detector arm extension recall

    Elekta recalls Infinity radiation therapy systems for a detector arm defect that could cause uncontrolled extension if a microswitch is improperly configured. No injuries reported.

    Product
    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0482-2024·2023-12-13

    HVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan

    Heartware is updating instructions for the HVAD ventricular assist device to clarify controller fault alarm conditions and component useful life guidance for 126 units distributed worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0481-2024·2023-12-13

    Ventricular Assist Device Instructions Updated for Alarm and Useful Life Clarification

    Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.

    Product
    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0479-2024·2023-12-13

    HeartWare HVAD Implant Kit Instructional Update for Fault Alarms

    The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.

    Product
    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0487-2024·2023-12-13

    Remington Medical drainage bags recalled due to packaging label date error

    Remington Medical is recalling drainage bags (Lot 2325111) due to errors in the 'Use by Date' and 'Date of Manufacturer' on box labels. Approximately 3,080 units distributed in PA and FL are affected.

    Product
    Remington MEDICAL Drainage Bag, REF 600-D;
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0470-2024·2023-12-13

    Intraocular Lens Devices May Not Meet Manufacturing Specifications

    Staar Surgical is recalling 3 units of its EVO+VISIAN Implantable Collamer Lens (phakic toric) due to a potential that devices may not meet specifications. No illnesses or injuries have been reported.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-0451-2024·2023-12-13

    Blood Culture Identification Panel Quality Control Test Reporting Issue

    BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.

    Product
    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0475-2024·2023-12-13

    HVAD Ventricular Assist Device Instructions Updated for Alarm Clarification

    Heartware, Inc. is updating instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and component useful life. The recall affects 45 units distributed worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0488-2024·2023-12-13

    Vyaire Flexible Patient Circuit 3100A Distributed Without U.S. Approval

    Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.

    Product
    vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0469-2024·2023-12-13

    EVO VISIAN Intraocular Lens Recalled Due to Specification Concerns

    Staar Surgical Company is recalling EVO VISIAN Implantable Collamer Lens devices due to potential specification defects. Two units distributed across the United States are affected.

    Product
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-0500-2024·2023-12-13

    Luminex VERIGENE BC-GP Utility Trays Recalled Due to Potential Defects

    Luminex Corporation is recalling 222 kits (4,440 VERIGENE BC-GP Utility Trays) used in blood culture testing due to potentially defective utility trays. The affected lot (062123018C) expires December 20, 2023.

    Product
    Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2024·2023-12-13

    TENS Devices Recalled for Missing Instruction Manual Warnings

    Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.

    Product
    Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2024·2023-12-06

    BD Insyte Autoguard IV Catheter Needles May Fail to Retract Properly

    BD Insyte Autoguard BC IV catheters may have needles that fail to retract properly, potentially causing contaminated needlestick injuries, blood leakage, and repeated insertion attempts.

    Product
    BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2024·2023-12-06

    Gastrointestinal Videoscope Recall Due to Improper Repair and Infection Risk

    Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.

    Product
    GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states