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.

1601–1625 of 1800

  • HighFDA (Devices)·Z-0916-2015·2015-01-21

    Boston Scientific Recalls Lotus TAVR Valve Prosthesis Due to Unlocking Risk

    Boston Scientific is recalling Lotus TAVR 25mm valve prostheses because the valve may unlock during release, potentially requiring additional procedures or surgery.

    Product
    Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific ao
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0949-2015·2015-01-21

    St. Jude Medical Merlin@home Transmitter Software Reset Recall

    St. Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because a software reset may cause backup operation in implanted cardiac devices.

    Product
    Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2015·2015-01-14

    Baxter Amia Automated PD Systems Recalled for Battery Charging Error

    Baxter Healthcare is recalling 55 Amia Automated PD systems due to a battery charging error that prevents the device from functioning.

    Product
    Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0889-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2015·2015-01-07

    Bard Caliber Inflation Device Recalled for Pressure Limitations

    Perouse Medical is recalling Bard Caliber inflation devices that may fail to reach required pressure, potentially delaying angioplasty procedures.

    Product
    Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2015·2014-12-31

    GE Healthcare Pediatric Defibrillation Electrodes Recalled for Arcing Risk

    Leonhard Lang GmbH is recalling GE Healthcare Pediatric Defibrillation Electrodes because arcing may cause malfunction, delaying or preventing life-saving therapy.

    Product
    GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2015·2014-12-31

    Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk

    Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.

    Product
    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0834-2015·2014-12-31

    Intuitive Surgical Recalls Fluorescence Imaging Procedure Kits for Missing Storage Info

    Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.

    Product
    Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2015·2014-12-24

    GE Healthcare Recalls Innova 4100IQ Fluoroscopic Imaging Systems

    GE Healthcare is recalling six Innova 4100IQ fluoroscopic systems due to a defect that may cause loss of real-time imaging or gantry motion.

    Product
    Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0590-2015·2014-12-17

    Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper

    Smith & Nephew is recalling 45 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.

    Product
    LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0456-2015·2014-12-10

    ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Changes

    ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2015·2014-11-12

    TriVascular Recalls Ovation Prime Abdominal Stent Grafts Due to Injection Issue

    TriVascular is recalling specific lots of Ovation Prime Abdominal Stent Grafts because the fill polymer syringe may empty rapidly during the implant procedure.

    Product
    Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0112-2015·2014-11-05

    FDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue

    The FDA is recalling 324 Puritan Bennett 980 ventilators because a software issue may cause the devices to become inoperative.

    Product
    Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0146-2015·2014-11-05

    Roche Recalls ACCU-CHEK Spirit Combo Insulin Pumps Due to Time Settings

    Roche is recalling 8,116 ACCU-CHEK Spirit Combo insulin pumps because a faulty capacitor may cause time and date settings to reset, potentially shifting insulin delivery schedules.

    Product
    ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15018·2014-10-30

    Visonic Recalls Amber Personal Emergency Response Pendants and Kits

    Visonic is recalling Amber Pendants and Kits because battery drain may shorten the low-battery warning period. No injuries have been reported.

    Product
    Visonic Amber Pendants and Visonic Amber Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2015·2014-10-29

    Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion

    Boston Scientific is recalling COGNIS CRT-Ds and TELIGENT ICDs due to a capacitor defect that may cause the battery to deplete prematurely.

    Product
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2738-2014·2014-10-08

    Baxter SPECTRUM Pump Recall Due to Service Technician Error

    Baxter Healthcare is recalling SPECTRUM Pumps because a service technician may not have followed established procedures between May 5 and June 3, 2014.

    Product
    SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2706-2014·2014-10-01

    Vapotherm Precision Flow Patient Circuit Recalled for Potential Water Leakage

    Vapotherm, Inc. is recalling 207 units of Precision Flow Disposable Patient Circuits because water may leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2642-2014·2014-09-24

    EMG Technology Recalls Vac-Assist Suction Units Due to Occluded Ports

    EMG Technology is recalling 1,452 Vac-Assist Suction Units because the canister lids may have occluded ports, potentially preventing proper fluid removal.

    Product
    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2572-2014·2014-09-10

    St Jude Medical Recalls Ellipse ICDs Due to High Voltage Capacitor Defect

    St Jude Medical is recalling Ellipse ICDs because internal capacitor damage may delay or prevent high voltage therapy delivery.

    Product
    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2014·2014-09-10

    Bio-Detek Recalls Medsolutions4U Multi-Function Electrodes Due to Connector Defect

    Bio-Detek, Inc. is recalling Medsolutions4U Multi-Function Electrodes because an incorrect wire connector prevents them from interfacing with PhysioControl Lifepak Defibrillators.

    Product
    Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2536-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

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

    Product
    4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-2541-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kit Tube Holders

    Smiths Medical ASD, Inc. is recalling H4052 Endo Tube Holders because the fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states