The Recall Desk

Hazard

Device Failure recalls

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

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.

226–240 of 240

  • HighFDA (Devices)·Z-2272-2021·2021-08-18

    Hip Implant Component Recalled Due to Potential Fretting Corrosion and Device Failure

    Biomet is recalling hip replacement components that could develop fretting corrosion and fail inside the body, potentially requiring revision surgery.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2021·2021-08-18

    Smith & Nephew Orthopedic Nail May Detach During Surgery

    Smith & Nephew is recalling an orthopedic surgical nail (BHR SQUARE HEADED, catalog #999908) that may detach during surgery. Forty-seven affected units have been distributed worldwide.

    Product
    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2021·2021-08-18

    Arcos Modular Hip Implant Cone Bodies Recalled for Fretting Corrosion

    Biomet is recalling specific lots of Arcos Modular Revision Hip System cone bodies due to potential fretting corrosion and device failure that could require surgical intervention.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2021·2021-08-18

    FDA Recalls Biomet Hip Implant for Potential Fretting Corrosion

    Biomet is recalling its Arcos Modular Revision Hip System Standard Cone Prox Body due to risk of fretting corrosion and device failure in the inner taper. Affected patients should consult their surgeon.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2021·2021-08-18

    Biomet Arcos Hip Implant Revision Bodies Recalled for Corrosion Risk

    Biomet is recalling specific Arcos hip implant components due to potential fretting corrosion of the inner taper that could lead to device failure and require surgical intervention.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2120-2021·2021-07-28

    Exactech Hip Implant Liners Recalled for Premature Wear Risk

    Exactech Connexion GXL acetabular polyethylene liners used in hip implants face premature wear risk in certain patient and implant configurations. Consult your orthopedic surgeon if you have this device.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2018-2021·2021-07-21

    Boston Scientific INGENIO CRT-P Pacemakers Recalled for Battery Defect

    Boston Scientific is recalling INGENIO CRT-P pacemakers that may develop high internal battery impedance, causing unexpected device resets and Safety Mode activation. Affected devices require replacement.

    Product
    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2050-2021·2021-07-21

    EcoFit Cementless Acetabular Cup Plugs May Loosen During Hip Surgery

    Central hole cover plugs on EcoFit cementless acetabular cups may come loose during surgical implantation, potentially extending operation time or requiring revision surgery. Fifty-one units in Florida and Texas are affected.

    Product
    EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2021·2021-07-14

    CoreValve Evolut PRO PLUS Delivery Catheter Systems recalled for actuator separation

    Medtronic is recalling CoreValve Evolut PRO PLUS Delivery Catheter Systems due to reports of actuator separation that could affect proper deployment of these cardiac devices.

    Product
    CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-1961-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set: Potential Tubing Detachment

    Edwards Lifesciences is recalling a pressure monitoring set due to potential detachment of the pressure tubing from the blood sampling system. The recall affects 290 units distributed across multiple US states and international locations.

    Product
    Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1849-2021·2021-06-23

    Angio Pack surgical kits recalled for insufficient welds in tubing

    Windstone Medical Packaging is recalling Angio Pack surgical kits containing angio tubing with incomplete or insufficient welds that may fail during use. The recall affects 190 units; no injuries have been reported.

    Product
    Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling HY10L28R3 perfusion system tubing packs (lot 221679870) manufactured with insufficient or incomplete welds. The recall affects units distributed in nine U.S. states.

    Product
    Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism May Fail Intraoperatively

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
    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
  • 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