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.

601–625 of 881

  • HighFDA (Devices)·Z-1616-2018·2018-05-16

    Boston Scientific Recalls Capio SLIM Suture Capturing Device Due to Breakage Risk

    Boston Scientific is recalling 21,250 units of the Capio SLIM Suture Capturing Device because the sutures may break or detach during surgery.

    Product
    Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1620-2018·2018-05-16

    Boston Scientific Recalls Capio Sutures Due to Breakage Risk

    Boston Scientific is recalling 4,144 units of Capio Standard Box 4 sutures because they may break or detach during surgery.

    Product
    Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1615-2018·2018-05-09

    IntroMedic Recalls Miriam Capsule Endoscope System Due to Battery Indicator Error

    IntroMedic Co., Ltd. is recalling 82 units of the Miriam Capsule Endoscope System because the battery indicator may incorrectly display orange when the battery is fully charged.

    Product
    Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2018·2018-04-25

    Cook Vacuum Pump Recalled for Electrical Shock and Burn Risk

    Cook Inc. is recalling 132 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.

    Product
    Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1461-2018·2018-04-25

    Cook Vacuum Pump Recalled for Electrical Shock and Burn Risk

    Cook Inc. is recalling 2,267 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.

    Product
    Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1428-2018·2018-04-25

    Halyard Closed Suction System Flex Connectors May Disconnect During Use

    Halyard Health is recalling certain Closed Suction Systems because Flex Connectors may become loose or disconnect before or during use.

    Product
    Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH CARE-7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2018·2018-04-18

    Orthofix Recalls Connector System Set Screws Due to Size Discrepancies

    Orthofix is voluntarily recalling specific lots of Connector System set screws because size discrepancies may prevent proper driver fit or cause stripping.

    Product
    ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1355-2018·2018-04-18

    Bard Infant Feeding Tube Recalled for Ineffective Connector Fusion

    C.R. Bard is recalling 23,400 infant feeding tubes because the tubing and connector may not be effectively fused.

    Product
    Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2018·2018-04-04

    ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Conductivity Issues

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a device performance review failed to meet clinical survivorship criteria.

    Product
    ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2018·2018-04-04

    DePuy Sigma HP Cemented Trochlear Implants Recalled for Elevated Revision Rates

    DePuy Orthopaedics is recalling specific Sigma HP Cemented Trochlear Implants due to elevated revision rates identified during post-market surveillance.

    Product
    (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System After Failed Performance Review

    Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X125 STER L H TROC NAIL 440X9X125 STER L H TROC NAIL 460X9X125 STER L H T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2018·2018-04-04

    Zimmer Biomet Recalls AIM Tibial Nails Due to High Revision Rates

    Zimmer Biomet is recalling AIM Tibial Nails because they failed a clinical analysis showing surgical revision rates exceeded acceptance criteria.

    Product
    AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 81
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1178-2018·2018-04-04

    ConMed Recalls Mini Infant Radiotranslucent Electrodes Due to Adhesive Defect

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on the contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2018·2018-04-04

    ConMed Pediatric Defibrillation Electrodes Recalled for Adhesive Conductivity Issues

    ConMed is recalling 18,720 pediatric defibrillation electrodes because adhesive on contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2018·2018-04-04

    Zimmer Biomet Recalls AIM Tibial Nails Due to High Revision Rates

    Zimmer Biomet is recalling AIM Tibial Nails because the surgical revision rate exceeded acceptance criteria in a clinical analysis.

    Product
    AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1233-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Screws

    Zimmer Biomet is recalling ACE Trochanteric Nail System screws because a device performance review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR SCREW 80MM STERILE ATN AR SCREW 85MM STERILE ATN AR SCREW 90MM STERILE ATN AR SCREW 95MM STERILE ATN AR SCREW 100MM STERILE Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2018·2018-03-21

    Zimmer Biomet Recalls Nondegradable Soft Tissue Fixation Fasteners

    Zimmer Biomet is recalling 429 units of nondegradable soft tissue fixation fasteners because the implant shaft may shift and fall out during device opening.

    Product
    fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0908-2018·2018-03-14

    FDA Recalls 163 Endo GIA Radial Reloads Due to Manufacturing Error

    The FDA is recalling 163 Endo GIA Radial Reloads with Tri-Staple Technology because the device cartridge disengaged during use due to a manufacturing error.

    Product
    Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0710-2018·2018-03-07

    Siemens Medical Solutions Recalls Artis zee and Artis zeego Foot Switches

    Siemens Medical Solutions is recalling 510 foot switch accessories for Artis zee and Artis zeego x-ray systems because they may fail to release radiation.

    Product
    Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
    Category
    Medical Device
    Distribution
    52 states
  • CriticalFDA (Devices)·Z-0587-2018·2018-02-28

    Medtronic Recalls Evera ICDs Due to Possible Therapy Prevention

    Medtronic is recalling 951 Evera ICDs and CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2018·2018-02-28

    Medtronic Recalls Visia AF MRI ICDs Due to Therapy Prevention Risk

    Medtronic is recalling 951 Visia AF MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2018·2018-02-28

    Medtronic Recalls 951 Evera MRI ICDs Due to Therapy Prevention Risk

    Medtronic is recalling 951 Evera MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy. Patients should contact their healthcare provider.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Produ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0636-2018·2018-02-28

    FDA Recalls Endo GIA Auto Suture Units Due to Safety Interlock Failure

    The FDA is recalling 3,816 Endo GIA Auto Suture Universal Articulating Loading Units because the safety interlock may fail, allowing an empty unit to be fired a second time.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    0 states