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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8526–8550 of 40007

  • HighFDA (Devices)·Z-0441-2024·2023-12-13

    Automated Impella Controller Software Defect Affecting Pump Connection Detection

    Abiomed is recalling Automated Impella Controller units with software versions V8.4 and V8.4.1 because a software issue may prevent proper pump connection detection. Affected devices were distributed in Arizona, California, Florida, New York, and Virginia.

    Product
    Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0492-2024·2023-12-13

    Integra Cranial Access Kit recall due to outer packaging defect

    Integra LifeSciences is recalling the Integra Cranial Access Kit due to a defect in the outer packaging that can split and compromise device sterility. A total of 173 units are affected.

    Product
    Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0456-2024·2023-12-13

    NovoTHOR Gen 2.5 XL Red Light Therapy Bed Canopy Gas Strut Detachment Recall

    Thor Photomedicine is recalling 26 NovoTHOR Gen 2.5 XL red light therapy beds due to ball stud component failure that can cause the gas strut to detach, making the canopy difficult to lift.

    Product
    NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
    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-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-0463-2024·2023-12-13

    Quantum TTC Biliary Balloon Dilator Recall Due to Balloon Detachment Risk

    Wilson-Cook Medical is recalling 157 Quantum TTC Biliary Balloon Dilator devices due to a design defect that may cause balloon detachment during use, potentially requiring emergency retrieval.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • 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-0457-2024·2023-12-13

    Biliary balloon dilators recalled due to design nonconformity and detachment risk

    Wilson-Cook Medical recalled 731 QUANTUM TTC biliary balloon dilators due to design nonconformity that could cause balloon detachment. The device failure may require endoscopic retrieval and risks bleeding complications.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
    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-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
  • 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-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-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-0471-2024·2023-12-13

    Intraocular lens recall: EVO+VISIAN devices may not meet specifications

    Staar Surgical is recalling 15 EVO+VISIAN Implantable Collamer Lens devices due to potential specification failures. The devices may not meet design specifications.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 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-0436-2024·2023-12-13

    Stryker ProCurity Hospital Beds Recalled for Missing Electrical Safety Tests

    Stryker is recalling ProCurity patient beds (model 3009) due to missing electrical safety test documentation. Affected beds pose a risk of electrical shock or tissue burns. Facilities should verify their bed serial numbers and contact Stryker.

    Product
    ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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-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-0491-2024·2023-12-13

    Integra Cranial Access Kit Recalled for Defective Outer Packaging

    Integra LifeSciences is recalling 1,639 units of its Cranial Access Kits because the outer packaging may split without additional external force, potentially compromising device sterility.

    Product
    Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
    Category
    Medical Device
    Distribution
    Distributed nationwide