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.

651–675 of 881

  • CriticalFDA (Drugs)·D-0690-2017·2017-05-10

    EpiPen Auto-Injectors Recalled for Defective Delivery System

    Meridian Medical Technologies is recalling EpiPen auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.

    Product
    EPIPEN — EPIPEN (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0691-2017·2017-05-10

    EpiPen Jr. Auto-Injectors Recalled for Delivery System Defects

    Meridian Medical Technologies is recalling EpiPen Jr. auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.

    Product
    EPIPEN — EPIPEN (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2017·2017-05-10

    Medtronic Recalls Newport HT70 Ventilators Due to Spontaneous Shutdown Risk

    Medtronic is voluntarily recalling Newport HT70 and HT70 Plus ventilators because they may shut down spontaneously without an alarm during normal operation.

    Product
    Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation thr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2017·2017-05-03

    Heartware Recalls HVAD System Controllers for Exchange

    Heartware is recalling all HVAD System Controllers currently on the market to exchange them for the next generation HVAD Controller (Controller 2.0).

    Product
    HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS)
    Category
    Medical Device
    Distribution
    37 states
  • CriticalFDA (Devices)·Z-1417-2017·2017-04-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Failure to Deliver Therapy

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver therapy or monitoring when operating on a single battery.

    Product
    HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2017·2017-04-05

    Philips V60 Ventilator Recall for False Blower Motor Stall Detection

    Respironics is recalling 2,512 Philips V60 Ventilators with Version 2.20 software because they may falsely detect a blower motor stall, causing the device to shut down and cease ventilatory support.

    Product
    Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1516-2017·2017-03-29

    Medtronic Recalls Poly Component Trials Due to Cracked or Broken Dovetails

    Medtronic is recalling 111 units of Poly Component Trials because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, RE
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1461-2017·2017-03-22

    Kiscomedica Recalls L-Varlock Cage/Trial Implant Holder Due to Breakage

    Kiscomedica S.A. is recalling 13 units of the L-Varlock Cage/Trial Implant Holder because the tip holder broke during use.

    Product
    L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1467-2017·2017-03-22

    Siemens Artis Zee and Zeego Fluoroscopic X-Ray System Recall

    Siemens is recalling Artis Zee and Zeego fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.

    Product
    Artis Zee and Zeego fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1466-2017·2017-03-22

    Siemens Artis Q and Q.Zen Fluoroscopic X-Ray System Recall

    Siemens is recalling Artis Q and Q.Zen fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.

    Product
    Artis Q and Q.Zen fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1192-2017·2017-02-22

    Integra Cadence Total Ankle System Recalled Due to Tibial Fractures

    Integra LifeSciences Corp. is recalling 944 units of the Cadence Total Ankle System because posterior tibial fractures have been reported.

    Product
    Integra Cadence Total Ankle System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2017·2017-02-22

    Physio-Control Recalls LIFEPAK 15 Defibrillators Due to Relay Failure

    Physio-Control is recalling 338 LIFEPAK 15 defibrillators because an internal relay may fail, preventing the device from delivering defibrillation energy.

    Product
    LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2017·2017-02-22

    Abbott StarClose SE Vascular Closure System Recall for Deployment Failure

    Abbott Vascular is recalling the StarClose SE Vascular Closure System because the device may fail to deploy the clip.

    Product
    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1211-2017·2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction OASIS Drain

    Atrium Medical Corporation is recalling 18 units of Maquet Express Dry Seal Suction OASIS Drain because the manual vent valve may fail to re-seal.

    Product
    Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2017·2017-02-22

    Merge Healthcare Recalls Schiller PB 1000 Blood Pressure Pumps

    Merge Healthcare is recalling Schiller PB 1000 blood pressure pumps because insufficient voltage causes them to fail before reaching adequate pressure.

    Product
    The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2017·2017-02-08

    Synthes Radial Head Prosthesis Recalled for Potential Stem Loosening

    Synthes (USA) Products LLC is recalling 50,311 units of the Radial Head Prosthesis System because the radial stem may loosen post-operatively at the stem bone interface.

    Product
    Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0968-2017·2017-01-25

    Bard Halo One Introducer Sheath Recalled for Separation and Kinking

    Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to complaints of separation, kinking, and tip damage during use.

    Product
    Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2017·2017-01-25

    Bard Halo One Introducer Sheath Recalled for Separation and Kinking

    Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to complaints of sheath separation, kinking, and tip damage during use.

    Product
    Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2017·2017-01-25

    Bard Halo One Introducer Sheath Recalled for Separation and Kinking

    Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to reports of sheath separation, kinking, and tip damage during use.

    Product
    Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and ve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2017·2017-01-11

    Smith & Nephew Recalls Modular REDAPT Hip Systems Due to Adverse Events

    Smith & Nephew is recalling 6,266 units of Modular REDAPT and Modular SMF Hip Systems worldwide due to a higher than anticipated complaint and adverse event trend.

    Product
    Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0887-2017·2016-12-28

    Amendia Recalls Black Widow Spinal Screws Due to Mating Feature Defect

    Amendia, Inc. is recalling 96 units of Black Widow 6.6mm spinal screws due to a design defect in the mating feature between the plate and screw.

    Product
    Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 33 units of the Adelante Breezway 10F Straight sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0891-2017·2016-12-28

    Amendia Recalls Optimus Fixed Awl Due to Tip Breakage During Surgery

    Amendia, Inc. is recalling nine Optimus Fixed Awl devices because the tip broke after impaction during surgery. The devices were distributed to Florida, Georgia, Illinois, Missouri, and Texas.

    Product
    Optimus Fixed Awl
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0802-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling eight Adelante Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of device failure.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states