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.

1101–1125 of 1800

  • HighFDA (Devices)·Z-0587-2019·2018-12-19

    GE Healthcare Recalls B105/125 Patient Monitors Due to Network Overload Risk

    GE Healthcare is recalling 5,516 B105/125 patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital trans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2019·2018-12-19

    GE Healthcare Recalls PROCARE B20 Patient Monitors Due to Network Issues

    GE Healthcare is recalling 28,004 PROCARE B20 patient monitors because network configuration issues may cause the devices to restart unexpectedly.

    Product
    PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hos
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2019·2018-12-19

    GE Healthcare Recalls B20i Patient Monitors Due to Network Overload Restart Risk

    GE Healthcare is recalling 6,458 B20i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2019·2018-12-19

    Medtronic HeartWare HVAD Battery Charger Recalled for Incorrect Inductors

    Heartware, Inc. is recalling 2,031 HVAD System Battery Charger units because they were manufactured with incorrect inductors. The recall covers units distributed in the US and multiple international countries.

    Product
    Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an altern
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0522-2019·2018-12-05

    GE Healthcare Recalls Solar 8000i Patient Monitoring Systems

    GE Healthcare is recalling approximately 73,673 Solar 8000i and 8000M patient monitoring systems because they may simultaneously restart during prolonged network overloads.

    Product
    Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2019·2018-12-05

    GE Healthcare Recalls Solar 9500 Patient Monitors Due to Network Overload Risk

    GE Healthcare is recalling approximately 3,864 Solar 9500 Information Monitoring Systems because they may simultaneously restart if connected to the same network during a prolonged network overload.

    Product
    Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0413-2019·2018-11-21

    GE Healthcare Recalls Aisys Anesthesia System Touchscreen Display Kits

    GE Healthcare is recalling 4,207 Aisys anesthesia system touchscreen display kits because they fail to transition to backup ventilation if a patient stops breathing.

    Product
    Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0469-2019·2018-11-21

    Tosoh AIA-900 Analyzer Recalled Due to Pickup Arm Malfunction

    Tosoh Bioscience is recalling 393 AIA-900 Analyzers because a pickup arm malfunction can stop the device from testing patient samples, causing delays in results.

    Product
    AIA-900 Analyzer, Product code 022930, 022930R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2019·2018-11-14

    Zimmer Biomet RapidFlap SpinDown Clamp Recalled for Assembly Error

    Zimmer Biomet is recalling 23,726 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling 11,580 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The devices are used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0394-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The defect affects 11,736 units distributed worldwide.

    Product
    Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0278-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0277-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems for Software Anomalies

    Medtronic Navigation is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D a
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0280-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits f
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Devices)·Z-0103-2019·2018-10-24

    Thoratec CentriMag Motor Recall Due to Electrical Cable Failure

    Thoratec is recalling CentriMag Motors because a wire break or short circuit in the cable can cause the motor to stop.

    Product
    Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0107-2019·2018-10-24

    Baxter Spectrum IQ Infusion System Recalled for Programming Error

    Baxter is recalling Spectrum IQ Infusion Systems because a software error prevents operators from programming certain infusions.

    Product
    SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0087-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Corner

    Orthosensor, Inc. is recalling 68 VERASENSE sensors for Zimmer Biomet Persona CR G-H/7-12 Right because fluid was reported inside the posterior lateral corner post-surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0085-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence

    Orthosensor, Inc. is recalling 36 VERASENSE sensors for Zimmer Biomet Persona CR C-D/3-9 Right knees because fluid was reported inside the posterior lateral corner post-surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-3388-2018·2018-10-10

    B. Braun Recalls Spinal and Epidural Catheter Connectors

    B. Braun Medical is recalling 200 spinal/epidural trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    GOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3261-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling specific HipLOC hip fracture fixation system plates due to an undersized bore that prevents the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3273-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation

    Bausch & Lomb is recalling Stellaris Elite 25 GA Vit Cutters because the back cap may separate from the cutter body.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states