The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
882
Critical
29
Severe
301
Most recent
2026-09-23

Of the 882 device failure recalls we have scored against our rubric, 29 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 301 (34%) 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.

551–575 of 882

  • HighFDA (Devices)·Z-2707-2018·2018-08-15

    Howmedica Recalls rHead Recon Extended Stem Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 19 rHead Recon Extended Stem implants due to a higher-than-expected revision rate.

    Product
    rHead Recon Extended Stem 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
  • HighFDA (Devices)·Z-2674-2018·2018-08-15

    Stryker rHead Radial Head Implant Recall Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 150 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Lateral Assembly, Radial Head Impl Assembly, 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
  • HighFDA (Devices)·Z-2720-2018·2018-08-15

    Howmedica Recalls 387 Stryker rHead Bipolar Stem Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 387 units of the #4 Bipolar stem implant from the Stryker rHead system because literature reviews indicate a higher revision rate than other similar devices.

    Product
    #4 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
  • HighFDA (Devices)·Z-2697-2018·2018-08-15

    Howmedica Recalls Radial Head Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 128 Radial Head Assembly Size #2 implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    Radial Head Assy Size #2, Rad. 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
  • HighFDA (Devices)·Z-2704-2018·2018-08-15

    Howmedica Recalls rHead Standard Extended Stem Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 66 units of rHead Standard Extended Stem implants due to higher-than-expected revision rates.

    Product
    rHead Standard Extended Stem, 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
  • HighFDA (Devices)·Z-2698-2018·2018-08-15

    Howmedica Recalls Radial Head Orthopedic Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 166 Radial Head Assy Size #3 orthopedic implants because the revision rate is higher than other similar devices.

    Product
    Radial Head Assy Size #3, Rad. 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
  • HighFDA (Devices)·Z-2730-2018·2018-08-15

    Howmedica Recalls rHead Radial Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 162 units of rHead Radial Implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    rHead, Radial Implant 6 mm Collar, 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
  • HighFDA (Devices)·Z-2709-2018·2018-08-15

    Howmedica Recalls rHead Recon Extended Stem Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 19 rHead Recon Extended Stem Size 3 orthopedic implants due to a higher-than-expected revision rate.

    Product
    rHead Recon Extended Stem 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
  • HighFDA (Devices)·Z-2705-2018·2018-08-15

    Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 45 rHead Standard Extended Stem implants because literature suggests a higher revision rate than other similar devices.

    Product
    rHead Standard Extended Stem, 6mm Collar, 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
  • HighFDA (Devices)·Z-2729-2018·2018-08-15

    Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 750 radial stem implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    radial stem implant #3 (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
  • HighFDA (Devices)·Z-2668-2018·2018-08-15

    Howmedica Radial Head Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 190 units of Lat Assembly, Rad Stem Implant, Collar 6mm, Size 2. The recall is due to higher revision rates identified in literature.

    Product
    Lat Assembly, Rad Stem Implant,Collar 6mm,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-2506-2018·2018-07-25

    Endo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled

    COVIDIEN MEDTRONIC is recalling Endo GIA 60 mm Articulating Vascular/Medium Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA60AVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2512-2018·2018-07-25

    Medtronic Endo GIA Reloads Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA 45mm reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2516-2018·2018-07-25

    Medtronic Tri-Staple 2.0 Curved Tip Reloads Recalled for Missing Sled Component

    Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2503-2018·2018-07-25

    Endo GIA 45 mm Articulating Medium/Thick Reload Recalled for Missing Sled Component

    COVIDIEN MEDTRONIC is recalling Endo GIA 45 mm Articulating Medium/Thick Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2515-2018·2018-07-25

    Medtronic Tri-Staple 2.0 Curved Tip Intelligent Reload Recall for Missing Sled

    Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2433-2018·2018-07-25

    AesDex Cardica C-Port xA PLUS Anastomosis System Recalled for Handle Damage

    AesDex is recalling 587 Cardica C-Port xA PLUS Anastomosis Systems because the handle mechanism may break during use, causing a loud noise and potential dispersion of plastic fragments.

    Product
    AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2396-2018·2018-07-18

    Stryker Recalls Nine Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling nine femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.

    Product
    Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2266-2018·2018-06-27

    Datex-Ohmeda CARESCAPE R860 Ventilators Recalled for Display Processor Failure

    Datex-Ohmeda is recalling CARESCAPE R860 ventilators with software version 10SP05 because the display processor may experience unexpected failure.

    Product
    CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2228-2018·2018-06-20

    Seaberg SAM XT-C Tourniquet Recalled for Potential Buckle Stitch Failure

    The Seaberg Company is recalling SAM XT-C tourniquets because internal testing showed stitches securing the buckle could fail, posing a risk of serious injury or death.

    Product
    Part #: SAM XT-C, Model: Hi-Viz Blue
    Category
    Medical Device
    Distribution
    23 states
  • SevereFDA (Devices)·Z-2226-2018·2018-06-20

    Seaberg SAM XT-M Tourniquet Recalled for Potential Buckle Failure

    The Seaberg Company is recalling SAM XT-M tourniquets because internal testing found stitches securing the buckle could fail, posing a risk of serious injury or death.

    Product
    Part #: SAM XT-M, Model: Tactical Black or Military
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-2158-2018·2018-06-20

    Sun Med Recalls Medline Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 30 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2161-2018·2018-06-20

    Maquet Aortic Arterial Cannula Recall Due to De-airing Plug Breakage Risk

    Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.

    Product
    Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2125-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling specific Rival Reduce Fracture Plating and Rival View Plating System box plates because locking screws failed to properly engage during surgery.

    Product
    Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2124-2018·2018-06-13

    Orthofix Locking Screws Recalled Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM…
    Category
    Medical Device
    Distribution
    19 states