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.

Filters

Agency

Category

Minimum severity

Clear filters

7801–7825 of 13652

  • HighFDA (Devices)·Z-0462-2024·2023-12-13

    FDA Recalls Biliary Balloon Dilators for Design Nonconformance

    Wilson-Cook Medical Inc. is recalling 888 units of the Quantum TTC Biliary Balloon Dilator due to design nonconformance that could cause balloon detachment during use, potentially requiring endoscopic retrieval or causing bleeding.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0502-2024·2023-12-13

    Cooper Surgical catheter recall due to component detachment risk

    The Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheter may detach or leak due to defective bonding material used in assembly. The 73 affected units were distributed nationwide and internationally.

    Product
    Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -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 fallopian tubes. Model: 61-3005
    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-0434-2024·2023-12-13

    ProCurity patient beds recalled for electrical safety testing defects

    Stryker is recalling ProCurity bed series (model 3009) due to missing electrical safety test values that could pose 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-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2024·2023-12-13

    VITROS ECO2 Chemistry Slides may produce inaccurate CO2 test results

    Ortho-Clinical Diagnostics is recalling certain VITROS ECO2 diagnostic slides that may produce inaccurate carbon dioxide measurements, potentially leading to misdiagnosis of acid-base balance disorders.

    Product
    VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT 76
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2024·2023-12-13

    HeartWare HVAD: Documentation Updates for Controller Fault and Component Life

    Heartware is updating instructional materials for the HVAD ventricular assist device to clarify when Controller Fault alarms sound and how to troubleshoot them. Updates also address component useful life instructions.

    Product
    PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0460-2024·2023-12-13

    FDA Recalls Biliary Balloon Dilators Due to Detachment Risk

    Wilson-Cook Medical is recalling 941 biliary balloon dilators that may detach during use. Detachment could require doctors to retrieve the device with an endoscope, which may cause bleeding.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0449-2024·2023-12-13

    Monarch Platform Bronchoscope Software Issue Causes Flipped Display

    Auris Health is recalling 110 units of the Monarch Platform bronchoscope due to a software defect that may flip the image display. This inverted view could impact visualization during airway procedures.

    Product
    Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0501-2024·2023-12-13

    RANDOX Total Bilirubin Reagent Recall Due to Elevated Patient Results

    Randox is recalling RANDOX Total Bilirubin reagent because reports indicate elevated patient results when using plasma samples with this reagent.

    Product
    RANDOX Total Bilirubin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2024·2023-12-13

    Elekta Versa HD radiation therapy system detector arm uncontrolled extension risk

    Certain Elekta Versa HD radiation therapy systems may experience uncontrolled detector arm extension due to microswitch setup issues. This recall affects 451 systems worldwide.

    Product
    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0476-2024·2023-12-13

    HeartWare HVAD Ventricular Assist Device Documentation Update

    HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.

    Product
    STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0439-2024·2023-12-13

    CardioQuip Modular Cooler-Heater Units Recalled for Heating Chamber Malfunction

    CardioQuip Modular Cooler-Heater units are being recalled due to a potential heating-chamber malfunction that could cause melting and burning of internal components. 125 units distributed across 15 US states are affected.

    Product
    CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0496-2024·2023-12-13

    Cranial Access Kit Recall Due to Packaging Defect Compromising Sterility

    Integra LifeSciences is recalling 485 Cranial Access Kits (Catalog INS7250) due to a packaging defect that can cause spontaneous splitting, compromising device sterility. The kits are used for surgical access to the brain.

    Product
    Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2024·2023-12-13

    EVO+VISIAN Implantable Collamer Lens Recalled for Specification Failure

    Staar Surgical is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens due to a potential that implanted devices may not meet specifications. The recall affects units distributed across multiple US states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0498-2024·2023-12-13

    Integra Cranial Access Kit recalled due to packaging defect

    Integra LifeSciences Corp. is recalling 173 units of its Cranial Access Kit due to a packaging defect that can split and compromise device sterility. No illnesses have been reported.

    Product
    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2024·2023-12-13

    Atrium Firm PVC Thoracic Catheter Recalled for Sterilization Nonconformance

    Atrium Medical Corporation is recalling 2,460 units of the Atrium Firm PVC Thoracic Catheter 36FR Straight due to sterilization nonconformance that caused premature product aging and inaccurate expiration dating. Facilities in 14 U.S. states are affected.

    Product
    Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0489-2024·2023-12-13

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

    Vyaire's Flexible Patient Circuits (29028-004) for the 3100A ventilator were distributed in the U.S., despite being approved only for use outside the U.S. They do not meet U.S. regulatory requirements.

    Product
    vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0443-2024·2023-12-13

    Medical Radiation Therapy System Potential Detector Arm Malfunction Due to Microswitch Issue

    Recall of approximately 1,019 Elekta Synergy radiation therapy systems due to potential uncontrolled extension of detector arms if the middle arm microswitch is incorrectly setup.

    Product
    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0452-2024·2023-12-13

    Ceiling-mounted equipment dispensers recalled for weakened suspension arm

    IHB Operations is recalling Freedom Boom ceiling-mounted equipment dispensers due to weakened connection points on the suspension arm that could cause equipment failure. The defect affects 1,497 units distributed across multiple US states.

    Product
    Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0432-2024·2023-12-13

    ProCuity Patient Beds Recalled for Missing Electrical Safety Tests

    Stryker's ProCuity bed series (model 3009) is being recalled due to missing electrical safety test documentation. The beds present a potential risk of electrical shock or tissue burn.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0465-2024·2023-12-13

    FDA Class II Recall: Intraocular Lens Implants May Not Meet Specifications

    Staar Surgical is recalling 133 units of EVO+VISIAN intraocular lenses that may not meet manufacturing specifications. The affected devices were distributed across multiple U.S. states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0472-2024·2023-12-13

    Intraocular Lens Implants Recalled Due to Potential Specification Non-Compliance

    Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0424-2024·2023-12-13

    ProCuity Patient Beds Missing Electrical Safety Tests: Burn and Shock Risk

    Stryker ProCuity patient beds lack required electrical safety test values, posing risk of tissue burn or electrical shock to patients and healthcare workers.

    Product
    ProCuity bed series, model number 3009, item number: 300900000000,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2024·2023-12-13

    EVO VISIAN Intraocular Lenses recalled for potential specification defects

    Staar Surgical Company is recalling 9 EVO VISIAN intraocular lenses due to potential specification non-compliance. The affected devices were distributed to 40 US states.

    Product
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0447-2024·2023-12-13

    Medical Radiation Therapy System Detector Arm Malfunction Poses Uncontrolled Extension Risk

    Elekta recalled its ELEKTA AXESSE radiation therapy system due to potential uncontrolled extension of detector arms if the microswitch is incorrectly configured. The recall affects 47 units distributed worldwide.

    Product
    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states