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.

701–725 of 881

  • HighFDA (Devices)·Z-1899-2016·2016-06-22

    CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect

    CareFusion is recalling AVEA GDE upgrade kits because an incorrect fuse may fail, causing loss of power to the ventilator's user interface.

    Product
    AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2016·2016-06-08

    Ventlab STAT-Check Resuscitation Bag Recall Due to Non-Functional CO2 Indicators

    Ventlab LLC is recalling STAT-Check Resuscitation Bags because the carbon dioxide indicators are non-functional and fail to change color during use.

    Product
    STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should onl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2016·2016-05-25

    Medtronic Recalls Visualase Cooled Laser Applicator Systems Due to Melting Risk

    Medtronic is recalling 120 Visualase Cooled Laser Applicator Systems because the catheters may melt during procedures.

    Product
    Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue th
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1635-2016·2016-05-18

    Stryker Recalls CinchLock Knotless Anchors Due to Internal Wire Breakage

    Stryker is recalling CinchLock Knotless Anchors after 13 reports of internal wire breakage upon deployment.

    Product
    CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1612-2016·2016-05-11

    Philips HeartStart MRx Monitor/Defibrillator Recall for Charging Failure

    Philips is recalling 17 HeartStart MRx Monitor/Defibrillators because a faulty circuit board may prevent the device from charging.

    Product
    HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life sup
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1342-2016·2016-04-27

    Boston Scientific Recalls Fetch 2 Aspiration Catheters Due to Shaft Breaks

    Boston Scientific is recalling Fetch 2 Aspiration Catheters because the catheter shafts may break, potentially requiring additional procedures to remove the broken piece from patients.

    Product
    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1327-2016·2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, potentially compromising the device's structural integrity.

    Product
    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and sel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2016·2016-04-13

    MicroAire PAL-R4011XL Cannula Recalled Due to Breakage During Surgery

    MicroAire is recalling PAL-R4011XL cannulas because three reports indicated the devices bent or broke during surgical procedures.

    Product
    MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2016·2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, which may affect the device's structural integrity.

    Product
    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and sel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2016·2016-03-16

    Bard Denali Filter Delivery Systems Recalled for Cracking Stop Cocks

    Bard Peripheral Vascular is recalling Denali Filter Delivery Systems because stop cocks may crack.

    Product
    Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0798-2016·2016-03-02

    Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Splits

    Cook Inc. is recalling 9,519 Shuttle Select Slip-Cath Catheters worldwide due to reports of catheter tip splits and separation, which can cause loss of function or complications.

    Product
    Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0829-2016·2016-03-02

    Cardiac Science Defibrillation Electrodes Recalled for Impedance Issues

    Cardiac Science is recalling specific defibrillation electrodes that may develop high electrical impedance, causing AED self-test failures.

    Product
    9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AE
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0689-2016·2016-02-03

    Cook Medical Recalls Zilver 518RX Vascular Stent Delivery Systems

    Cook Medical is recalling 753 Zilver 518RX Vascular Stent delivery systems because a manufacturing defect may cause the catheter joint to separate during use.

    Product
    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0424-2016·2015-12-30

    Aesculap Flexible Drill Recalled Due to Potential Shaft Breakage During Surgery

    Aesculap, Inc. is recalling 13 Flexible Drill instruments (SJ723R) because the flexible shaft may break during orthopedic spinal surgery, posing a risk of surgical delay or retained fragments.

    Product
    Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2016·2015-12-23

    Verathon GlideScope AVL Video Laryngoscope Blades Recalled for Separation Risk

    Verathon is recalling GlideScope AVL video laryngoscope blades because silicone adhesive bonding may be inadequate, creating a risk of blade separation during use.

    Product
    GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0277-2016·2015-11-25

    Teleflex Medical Recalls Taut Intraducers Due to Gas Leakage Risk

    Teleflex Medical is recalling 2,050 Taut Intraducers 10/BX7.5 FR 3.5 devices because a defective component can cause gas leakage, potentially requiring device replacement.

    Product
    Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0230-2016·2015-11-25

    Event Medical Recalls Inspiration Ventilators Due to Power Board Failure

    Event Medical is recalling Inspiration Ventilator Systems because a power board component can fail, causing the device to shut down without an alarm.

    Product
    Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0123-2016·2015-10-21

    Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk

    Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System due to a potential balloon leak that may prevent the device from delivering therapy when needed.

    Product
    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2824-2015·2015-10-07

    Medtronic Navigated Solera Screwdrivers Recalled for Potential Tip Deformation

    Medtronic Navigation is recalling 2,346 Navigated Solera Screwdrivers used in spine surgery because specific use conditions may cause the tips to deform or break.

    Product
    P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2823-2015·2015-10-07

    Medtronic Solera Screwdrivers Recalled for Tip Deformation Risk

    Medtronic Navigation is recalling 2,346 Solera screwdrivers used in spine surgery because specific conditions may cause the tips to deform or break.

    Product
    P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN; P/N: 9735027,DRIVER 9735027 SOLERA 5.5/6.0 FAS/SAS. The Medtronic Navig
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2015·2015-09-23

    Sony Medical Monitors Recalled for Failure to Power On or Display Image

    Sony Medical Systems is recalling 4,952 medical monitors that may fail to turn on or lose image during clinical use.

    Product
    Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2485-2015·2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because they may fail to deploy or retract the cannula, potentially disrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2484-2015·2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Cannula Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because the cannula may fail to deploy or retract, potentially interrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide