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.

1576–1600 of 1800

  • HighFDA (Devices)·Z-2154-2015·2015-07-29

    Bausch & Lomb SoFlex SE Intraocular Lens Recall for Haptic Breakage

    Bausch & Lomb is recalling SoFlex SE foldable intraocular lenses because haptics may break during loading and insertion.

    Product
    Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2082-2015·2015-07-22

    FDA Recalls Autopen Classic Automatic Insulin Delivery Pens Due to Dial Defect

    Owen Mumford USA is recalling Autopen Classic Automatic insulin delivery pens because the dose dial fails to stay set, preventing patients from administering their medication.

    Product
    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2015·2015-07-22

    Breas Vivo 50 Home Care Ventilator Recalled for Keypad Malfunction

    Breas Medical AB is recalling 846 Vivo 50 Home Care Ventilators because a keypad malfunction can cause the device to stop treatment without an alarm.

    Product
    Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1917-2015·2015-07-08

    HeartWare Ventricular Assist System Recalled for Power Switching Issues

    HeartWare Inc. is recalling HVAD systems due to abnormal power source switching. The device is used as a bridge to cardiac transplantation.

    Product
    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1979-2015·2015-07-08

    GE Healthcare Recalls Innova 3131IQ Angiographic X-ray Systems

    GE Healthcare is recalling two Innova 3131IQ angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1937-2015·2015-07-08

    Atrium Medical Recalls Oasis Chest Drains Due to Missing O-Ring

    Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal Chest Drains because they have a missing o-ring. The recall covers 1,170 cases distributed nationwide and in Canada and Germany.

    Product
    Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2015·2015-07-08

    Medtronic Recalls DLP Femoral Arterial Cannulas Due to Connection Issues

    Medtronic is recalling specific lots of DLP Femoral Arterial Cannulas because users reported difficulty connecting the device to perfusion circuit tubing.

    Product
    Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter tran
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1958-2015·2015-07-08

    Siemens Recalls 37 Cios Alpha Mobile X-ray Systems for Freezing Defect

    Siemens is recalling 37 Cios Alpha mobile X-ray systems because they may freeze during procedures. The recall is classified as Class II.

    Product
    Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2015·2015-06-24

    Smiths Medical Recalls CADD-Solis Pumps Due to Locking Assembly Binding

    Smiths Medical is recalling CADD-Solis Ambulatory Infusion Pumps because the locking assembly may bind, preventing the cassette or keypad from locking securely.

    Product
    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2015·2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner Due to Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, potentially allowing incomplete disinfection cycles.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2015·2015-06-17

    Biomet Recalls Unilateral External Fixation Ankle Clamps Due to Assembly Error

    Biomet, Inc. is recalling 19 unilateral external fixation ankle clamps because they were assembled incorrectly. The defect may prevent full range of motion and cause the pin to loosen from the bone.

    Product
    Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2015·2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner for Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, allowing the cleaning cycle to complete without proper processing.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1609-2015·2015-06-03

    CareFusion AVEA Ventilator Recalled for Pressure Transducer Failure

    CareFusion is recalling AVEA ventilators because a pressure transducer failure can stop ventilation. Nonbreathing patients may require manual ventilation or a different device.

    Product
    CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2015·2015-05-13

    Spacelabs Ultraview SL Command Modules Recalled for Random Resets

    Spacelabs is recalling Ultraview SL Command Modules with specific Masimo SpO2 components due to a defect causing random resets.

    Product
    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1536-2015·2015-05-06

    Baxter Patient Control Modules Recalled for Potential Malfunction

    Baxter Healthcare is recalling 7,596 Patient Control Modules due to a potential malfunction that could cause medication to flow when it should not.

    Product
    The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1559-2015·2015-05-06

    Steris Caviwave Pro Ultrasonic Cleaning System Recalled for Power Failure Risk

    Steris is recalling 491 Caviwave Pro Ultrasonic Cleaning Systems because a power interruption may stop the pump and generator without alerting the user.

    Product
    Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1525-2015·2015-05-06

    Biosense Webster HIS Catheter Recall Due to Navigation System Compatibility Issue

    Biosense Webster is recalling 503 Webster HIS Catheters because they are not recognized by the CARTO 3 navigation system.

    Product
    WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2015·2015-04-29

    Wright Medical Crosscheck Plating System Recalled for Dimensional Defects

    Wright Medical Technology is recalling 138 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2015·2015-03-25

    St Jude Medical Recalls TactiSys Quartz Pack for Configuration Update

    St Jude Medical is recalling 89 TactiSys Quartz Packs because a configuration update is needed to ensure the device appropriately recognizes all TactiCath catheters.

    Product
    TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2015·2015-03-11

    iCAD Recalls DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

    iCAD, Inc. is recalling DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 because a device malfunction may cause biopsy needles to miss targets, potentially leading to incorrect diagnoses.

    Product
    DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2015·2015-02-18

    Maquet Intra-Aortic Balloon Pump Demonstration Units Recalled for Ferrule Cap Defect

    Maquet Datascope is recalling specific intra-aortic balloon pump demonstration units because a ferrule cap was not removed, which could prevent connection or become dislodged in the device.

    Product
    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1034-2015·2015-02-11

    Animas Vibe Insulin Pump Recalled Due to Calibration Factor Overwrite

    Animas Corporation is recalling 1,235 Vibe Insulin Infusion Pumps because calibration factors were overwritten, potentially causing the pump to fail to detect cartridges or alarms.

    Product
    Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1029-2015·2015-02-04

    Orthosensor Recalls Verasense Knee System Due to Inoperable Sensor Pad

    Orthosensor, Inc. is recalling 22 Verasense Knee System devices because one sensor pad is inoperable. The devices were distributed to six U.S. states.

    Product
    Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0915-2015·2015-01-21

    Boston Scientific Recalls Lotus TAVR 23mm Transcatheter Aortic Valve Prosthesis

    Boston Scientific is recalling 278 units of the Lotus TAVR 23mm valve because the device may unlock during release, potentially causing the valve to embolize.

    Product
    Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific a
    Category
    Medical Device
    Distribution
    0 states