The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device malfunction recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

526–550 of 1800

  • HighFDA (Devices)·Z-2046-2023·2023-07-05

    Knee Prosthesis System Components Recalled for Specification Non-Compliance

    Waldemar Link GmbH & Co. KG is recalling 21 units of LINK Endo-Model Modular Knee Prosthesis System Femoral Segment components because they may not meet manufacturing specifications. No injuries have been reported.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2050-2023·2023-07-05

    Exactech Shoulder GPS Impactor Handle Recalled for Locking Mechanism Defect

    Exactech is recalling 250 units of its Shoulder GPS Impactor Handle due to a defect where the ball and spring in the locking mechanism can dislodge during disassembly or impaction. The defect could affect the device's function during surgical use.

    Product
    Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2038-2023·2023-07-05

    Remel Haemophilus Test Medium Agar Packages Recalled for Performance Failure

    Remel is recalling specific lot numbers of Haemophilus Test Medium (Agar) because the test medium may not perform as intended. This diagnostic device is used in laboratory testing nationwide.

    Product
    Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2023·2023-07-05

    Vanta Implantable Neurostimulator May Become Unresponsive During Cardioversion

    Cardioversion procedures can damage electronics in Vanta implantable neurostimulators, making them unresponsive. Medtronic has received two complaints resulting in device removal surgeries.

    Product
    Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2035-2023·2023-07-05

    Sertera 14 Gauge Biopsy Device: Needle Detachment Risk

    Hologic's Sertera 14 Gauge Biopsy Device may experience inner needle detachment or discharge during use, which could delay breast biopsy surgery. The company is recalling 756 units nationwide.

    Product
    Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1738-2023·2023-06-28

    Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output During Therapy

    Certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may fail to deliver adequate energy during high-voltage therapy due to a specific feedthrough defect. Medtronic is recalling 1,132 affected units.

    Product
    CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1755-2023·2023-06-28

    Implantable Cardioverter Defibrillators Risk Therapy Failure Due to Feedthrough Defect

    Medtronic implantable cardioverter defibrillators may fail to deliver critical therapy due to a feedthrough defect. The defect can cause reduced or absent energy output during high-voltage therapy in 8,602 affected units distributed worldwide.

    Product
    CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1725-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure

    Medtronic's ICD COBALT defibrillators may fail to deliver critical therapy due to a manufacturing defect in a power delivery component. Patients should contact their physician to determine if affected.

    Product
    ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1719-2023·2023-06-28

    Medtronic MIRRO MRI Implantable Defibrillator Recall for Potential Therapy Failure Risk

    Medtronic's MIRRO MRI implantable cardioverter defibrillators with a specific glassed feedthrough may rarely fail to deliver adequate energy output during high-voltage therapy, affecting approximately 2,831 units distributed worldwide.

    Product
    ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1744-2023·2023-06-28

    Medtronic CRT-D Defibrillators Recalled for Potential Therapy Output Failure

    Medtronic implantable cardiac defibrillators (CRT-D) may deliver reduced or no energy during critical high-voltage therapy due to a feedthrough defect. The recall affects 193 units that could fail to deliver lifesaving defibrillation shocks when needed.

    Product
    CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1706-2023·2023-06-28

    Implantable Defibrillators Recalled for Potential Therapy Failure During High-Voltage Treatment

    Medtronic is recalling specific Implantable Cardioverter Defibrillator (ICD) models due to a rare potential for reduced or no energy output during high-voltage therapy. The issue is related to a specific manufacturing defect in the device feedthrough.

    Product
    ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1771-2023·2023-06-28

    Medtronic implantable defibrillators may fail to deliver therapy

    Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with specific feedthrough components may fail to deliver adequate high-voltage therapy output.

    Product
    CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1729-2023·2023-06-28

    Medtronic CRT-D Implants Recalled for Rare Energy Output Failure Risk

    Medtronic is recalling certain CRT-D (cardiac resynchronization therapy defibrillator) models due to a rare risk of reduced or no energy output during high-voltage therapy. The FDA has classified this as a Class I recall affecting 1,473 units.

    Product
    CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1822-2023·2023-06-28

    Implantable Heart Defibrillators May Fail to Deliver Therapy

    Medtronic implantable heart defibrillators may fail to deliver therapy during emergencies. The rare defect affects 510 devices distributed nationwide and worldwide.

    Product
    ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1775-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillator Model DTPA2D1G Therapy Output Failure

    Medtronic Inc. is recalling five units of the CRTD DTPA2D1G COBALT XT HF QUAD OUS implantable cardioverter defibrillator due to a rare potential for reduced or no energy output during high-voltage defibrillation therapy.

    Product
    CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1820-2023·2023-06-28

    ICD Cobalt VR MRI Implantable Defibrillators Recall Due to Potential Therapy Failure

    Medtronic is recalling 1,930 ICD Cobalt VR MRI implantable defibrillators due to a rare risk of reduced or no-energy output during high voltage therapy. The defect affects units with a specific glassed feedthrough component.

    Product
    ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1802-2023·2023-06-28

    Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic is recalling 289 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare potential defect that may prevent proper high-voltage therapy delivery.

    Product
    ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1806-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver Therapy

    Medtronic is recalling 15,381 implantable cardioverter defibrillators due to rare potential for reduced or absent energy output during high-voltage therapy caused by a specific feedthrough design defect.

    Product
    ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1804-2023·2023-06-28

    Implantable Cardioverter Defibrillators Risk Failure to Deliver Therapy

    Medtronic implantable cardioverter defibrillators with a specific feedthrough defect may rarely fail to deliver high-voltage therapy. Approximately 34,350 devices distributed worldwide are affected.

    Product
    ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1805-2023·2023-06-28

    Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output

    Medtronic ICDs and CRT-Ds with a specific feedthrough defect may produce reduced or no energy output during high-voltage therapy. The recall involves approximately 4,546 units distributed nationwide and worldwide.

    Product
    ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1736-2023·2023-06-28

    Medtronic Implantable Defibrillators May Fail to Deliver Therapy

    Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare risk of reduced or no energy output during high voltage therapy.

    Product
    CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1780-2023·2023-06-28

    Medtronic ICD COBALT XT implants may deliver reduced or no therapy

    Medtronic's ICD COBALT XT HF QUAD implantable defibrillators may deliver reduced or no energy output during high voltage therapy. The FDA has classified this as a Class I recall.

    Product
    ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1705-2023·2023-06-28

    Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy

    Medtronic is recalling 522 implantable cardioverter defibrillators that may deliver reduced or no energy during high-voltage therapy due to a feedthrough defect.

    Product
    ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1758-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Therapeutic Shock

    Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially failing to deliver life-saving shocks.

    Product
    CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide