The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device malfunction 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.

1626–1650 of 1800

  • HighFDA (Devices)·Z-2540-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Compression

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • ModerateFDA (Devices)·Z-2263-2014·2014-08-27

    Biolase Recalls WaterLase iPlus Dental Laser Systems Due to Software Error

    Biolase Technology Inc is recalling 117 WaterLase iPlus Dental Laser Systems because a software error may cause the air setting to change to 1% and OFF during procedures.

    Product
    WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2230-2014·2014-08-20

    Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain assembled to the rasp during use.

    Product
    23.5 Deg Rasp Handle Assy- LEFT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2014·2014-08-20

    Medtronic MiniMed Implantable Insulin Pump Recalled for Malfunction

    Medtronic MiniMed is recalling 764 Implantable Insulin Pumps due to reports of pump malfunction causing insulin delivery to stop before the device's 7-year useful life ends.

    Product
    Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2108-2014·2014-07-30

    Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect

    Teleflex Medical is recalling Hudson RCI breathing circuits because the temperature probe does not properly connect to the temperature port.

    Product
    Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Conch
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2081-2014·2014-07-30

    AGFA DX-D 100 X-Ray System Recalled for Touch Screen Malfunction

    AGFA Corp. is recalling 216 DX-D 100 digital radiography systems because liquid contact with the touch screen may cause the device to incorrectly recognize user input and alter settings.

    Product
    AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2014·2014-07-23

    Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks

    Terumo is recalling Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.

    Product
    Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2022-2014·2014-07-16

    B. Braun Stopcock Extension Sets Recalled for Reverse Assembly Defect

    B. Braun Medical is recalling 10,835 Stopcock Extension Sets because some stopcocks are assembled in reverse, causing them to close when set to open.

    Product
    STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1423-2014·2014-07-16

    United Therapeutics Recalls Tyvaso Inhalation Systems Due to Software Defect

    United Therapeutics is voluntarily recalling Tyvaso Inhalation Systems with specific medical devices that may have incorrect software, potentially causing them to not operate as instructed.

    Product
    Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1803-2014·2014-06-25

    Biomet Recalls EZPass Suture Passer Due to Wire Buckling

    Biomet, Inc. is recalling 102 EZPass Suture Passers because the nitinol wire may buckle and become kinked, making the instrument difficult to use.

    Product
    EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1801-2014·2014-06-25

    Biomet Recalls EZPass Suture Retriever Due to Nitinol Wire Buckling

    Biomet is recalling 100 units of EZPass Suture Retriever instruments because the nitinol wire may buckle and become kinked, making the device difficult to use.

    Product
    EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1791-2014·2014-06-25

    Roche cobas 6000 Analyzer Filters Recalled for Potential Aspiration Issues

    Roche Diagnostics is recalling cobas 6000 analyzer filters that may cause discrepant results and system alarms.

    Product
    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2014·2014-06-18

    Neo Metrics Recalls NovaGold Guidewires Due to Tip Uncoiling Risk

    Neo Metrics, Inc. is recalling NovaGold High Performance Guidewires because the tip may uncoil or detach more frequently than anticipated. No illnesses or injuries have been reported.

    Product
    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation o
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1751-2014·2014-06-18

    Stryker 2.0mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 252 sterile 2.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1762-2014·2014-06-18

    Stryker Zyphr Elite Round Fluted Bur Recall for Missing Notches

    Stryker is recalling 39 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1763-2014·2014-06-18

    Stryker Recalls Four Zyphr Elite Round Fluted Bur Units

    Stryker is recalling four sterile Zyphr Elite Round Fluted Bur units due to missing or partial notches that may affect compatibility with Elite attachments.

    Product
    Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2014·2014-06-11

    Aesculap Miethke Ventricular Catheter Recalled Due to Deflector Movement Issues

    Aesculap, Inc. is recalling 48 units of the Miethke Ventricular Catheter with Deflector because the deflector did not move freely in three reported cases.

    Product
    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1661-2014·2014-06-04

    Medtronic Temporary Pacemaker Recalled for Pacing Rate Defect

    Medtronic is recalling 16,337 temporary pacemakers worldwide because oxidation on internal contacts can cause the pacing rate to increase unexpectedly to 180 pulses per minute.

    Product
    Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connecte
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1660-2014·2014-06-04

    Physio-Control Recalls LIFEPAK 1000 Defibrillators Due to Unexpected Shutdowns

    Physio-Control is recalling 96,611 LIFEPAK 1000 defibrillators because a software malfunction can cause the device to shut down unexpectedly, potentially failing to deliver a life-saving shock.

    Product
    LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2014·2014-05-28

    GE Healthcare Recalls NeuroMuscular Transmission Modules for Inaccurate Readings

    GE Healthcare is recalling 1,794 NeuroMuscular Transmission Modules because they may display inaccurate muscle relaxation levels when used with ElectroSensors.

    Product
    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2014·2014-05-21

    Fresenius Hemodialysis Machines Recalled for Potential UF Pump Detection Failure

    Fresenius Medical Care is recalling 79 hemodialysis machines and replacement parts because they may fail to detect a disconnected Ultrafiltration (UF) Pump.

    Product
    Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2014·2014-05-21

    HeartWare HVAD Pump Implant Kit Battery Recall for Support Issues

    HeartWare Inc is recalling HVAD Pump Implant Kit batteries that may not provide two hours of support or behave unusually.

    Product
    HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and o
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1568-2014·2014-05-14

    Medtronic Refill Kits Recalled Due to Occluded Extension Tubing Sets

    Medtronic is recalling specific Refill Kits for implantable infusion pumps because some contain occluded extension tubing that prevents filling. No patient injuries beyond additional needle sticks have been reported.

    Product
    Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2014·2014-04-23

    SpaceLabs Arkon Anesthesia Delivery System Recalled for Software Failure

    Del Mar Reynolds Medical is recalling 16 SpaceLabs Arkon Anesthesia Delivery Systems with Version 2.0 software because they may enter a controlled failed state.

    Product
    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1440-2014·2014-04-16

    Draeger Oxylog 3000 Plus Ventilators Recalled Due to Potentiometer Fault

    Draeger Medical Systems is recalling three Oxylog 3000 plus ventilators because the control knobs may interrupt contact, causing the device to stop ventilation.

    Product
    Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
    Category
    Medical Device
    Distribution
    Distributed nationwide