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.

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 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.

476–500 of 881

  • HighFDA (Devices)·Z-0175-2019·2018-10-24

    Philips HeartStart FR3 Defibrillators Recalled for Water Ingress Risk

    Philips is recalling 432 HeartStart FR3 defibrillators because they may not meet water resistance specifications, potentially causing device failure if water enters.

    Product
    Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2019·2018-10-10

    Smith & Nephew Recalls Journey BCS Oxinium Knee Femoral Components

    Smith & Nephew is recalling Journey BCS Oxinium knee femoral components due to elevated revision rates reported in international joint registries.

    Product
    JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 7402113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0001-2019·2018-10-10

    Smith & Nephew Recalls Journey BCS Knee CoCr Femoral Components

    Smith & Nephew is recalling Journey BCS Knee CoCr Femoral Components because registry data indicates the first-generation system has a revision rate over 1.5 times the class average.

    Product
    Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2019·2018-10-10

    Smith & Nephew Recalls JOURNEY BCS Knee Polyethylene Inserts

    Smith & Nephew is recalling JOURNEY BCS Knee Conventional Polyethylene Inserts due to elevated revision rates reported in international joint registries.

    Product
    JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 7402313
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0008-2019·2018-10-10

    Endologix AFX Endograft Recall for Type III Endoleak Surveillance

    Endologix is notifying physicians of updated surveillance recommendations for AFX endografts due to observed Type III endoleaks.

    Product
    ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A2
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-3255-2018·2018-10-03

    Boston Scientific Recalls ESSENTIO Pacemakers Due to Battery Depletion

    Boston Scientific is recalling ESSENTIO pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.

    Product
    ESSENTIO Pacemaker
    Category
    Medical Device
    Distribution
    48 states
  • SevereFDA (Devices)·Z-3268-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation

    Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the body of the device.

    Product
    Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3247-2018·2018-10-03

    Shockwave S4 IVL Catheters Recalled for Inflation Pressure Failure

    Shockwave Medical is recalling 612 Shockwave S4 IVL Catheters because they may fail to maintain required inflation pressure during treatment.

    Product
    The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral In
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3266-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation

    Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3270-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall

    Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the cutter body.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3274-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall

    Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the cutter body during use.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-2824-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Pacing and Sensing Loss

    Sorin CRM SAS is recalling 16 Platinium CRT-D devices because a hardware defect may cause loss of pacing and sensing, preventing the device from delivering necessary defibrillation.

    Product
    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2825-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Loss of Pacing and Sensing

    Sorin CRM SAS is recalling 10 Platinium CRT-D devices because a hardware issue may cause loss of pacing and sensing, preventing the device from detecting arrhythmias.

    Product
    Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2703-2018·2018-08-15

    Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2716-2018·2018-08-15

    Howmedica Recalls Stryker rHead Radial Head Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.

    Product
    #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2690-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 269 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2675-2018·2018-08-15

    Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 191 Stryker rHead Radial Head implant assemblies because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide