The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device failure 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.

251–275 of 881

  • HighFDA (Devices)·Z-1804-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Recall: Potential Screw Mechanism Failure

    Alphatec Spine is recalling 7 units of the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism May Disassociate or Unlock

    Alphatec Spine recalls its Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during spinal surgery or unlock afterward. Healthcare providers should contact the manufacturer for guidance.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1630-2021·2021-06-02

    Philips Respironics BiPAP A40 Ventilator Recall for Material Defects

    Philips Respironics is recalling four BiPAP A40 ventilators because non-conforming plastic in the motor assembly may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1629-2021·2021-06-02

    Philips Respironics BiPAP A30 Ventilator Recall for Motor Assembly Defect

    Philips Respironics is recalling two BiPAP A30 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1626-2021·2021-06-02

    Philips Respironics BiPAP A40 Ventilators Recalled for Motor Assembly Defects

    Philips Respironics is recalling 10 BiPAP A40 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1625-2021·2021-06-02

    Philips Respironics BiPAP V30 Auto Recall for Non-Conforming Plastic Material

    Philips Respironics is recalling 22 BiPAP V30 Auto ventilators because non-conforming plastic in motor assemblies may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1628-2021·2021-06-02

    Philips Respironics BiPAP A40 System Silver Recalled for Motor Assembly Defect

    Philips Respironics is recalling four BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may off-gas or fail, posing asphyxia risks.

    Product
    BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1627-2021·2021-06-02

    Philips BiPAP A40 System Silver Recalled for Motor Assembly Defects

    Philips Respironics is recalling specific BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may cause off-gassing or sudden device failure.

    Product
    BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2021·2021-05-19

    Abbott NeuroTherm Radiofrequency Generator Recalled for Capacitor Failure

    Abbott is recalling 318 NeuroTherm NT2000iX Radiofrequency Generators due to potential capacitor failure that may cause output loss or smoky odors.

    Product
    NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1526-2021·2021-05-12

    Medtronic Recalls CRT-P Pacemakers Due to Longevity Estimation Error

    Medtronic is recalling specific implantable cardiac resynchronization therapy pacemakers because a longevity estimation error may occur in the early years of device life.

    Product
    Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CR
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1523-2021·2021-05-12

    Medtronic Recalls CRT-P Quad Models Due to Software Longevity Error

    Medtronic is recalling 45,411 CRT-P Quad implantable devices worldwide because a software issue overestimates battery longevity for six months before replacement is due.

    Product
    CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and card
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1460-2021·2021-04-28

    Biotronik Inventa 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 285 Inventa 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1445-2021·2021-04-28

    BIOTRONIK Ilestro 7 VR-T DX Defibrillators Recalled for Battery Depletion

    BIOTRONIK Inc is recalling 3,664 Ilestro 7 VR-T DX implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1459-2021·2021-04-28

    Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling Inventa 7 ICDs and CRT-Ds due to a potential for premature battery depletion. The recall covers devices distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1437-2021·2021-04-28

    Stryker Recalls Tritanium X TL Spinal Instruments Due to Failure Risk

    Stryker Spine is recalling 169 sets of Tritanium X TL instruments because non-conforming components could lead to device failure during surgery.

    Product
    Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1444-2021·2021-04-28

    Biotronik Ilestro 7 VR-T Defibrillators Recalled for Battery Depletion Risk

    Biotronik is recalling 323 Ilestro 7 VR-T defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2021·2021-04-28

    BIOTRONIK Iforia 7 Defibrillators Recalled for Premature Battery Depletion

    BIOTRONIK is recalling 490 Iforia 7 implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2021·2021-04-28

    Biotronik ILIVIA NEO 7 DR-T DF-1 ProMRI Defibrillators Recalled for Battery Depletion

    Biotronik is recalling 98 ILIVIA NEO 7 DR-T DF-1 ProMRI defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2021·2021-04-28

    Biotronik Iperia 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 1,652 Iperia 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2021·2021-04-28

    Biotronik Ilestro 7 VR-T Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 1,000 Ilestro 7 VR-T implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2021·2021-04-28

    Biotronik ILIVIA 7 ICD Recall for Premature Battery Depletion

    Biotronik is recalling 3,497 ILIVIA 7 implantable cardioverter defibrillators due to a potential for premature battery depletion. The recall covers units distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2021·2021-04-28

    Biotronik ILIVIA 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling 914 ILIVIA 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2021·2021-04-28

    Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling 702 Inventa 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1458-2021·2021-04-28

    Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 779 ILIVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2021·2021-04-28

    Biotronik Iforia 7 ICDs Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 1,176 Iforia 7 implantable cardioverter defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide