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.

1651–1675 of 1800

  • HighFDA (Devices)·Z-1439-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recalled for Therapy Board Malfunction

    Philips is recalling 19 HeartStart XL+ defibrillators because a therapy board component could malfunction, potentially affecting the device's ability to deliver therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1311-2014·2014-04-09

    Zoll Medical Defibrillators Recalled for Continuous Device Reset Loop

    Zoll Medical is recalling 3,169 defibrillator/pacemaker/monitor units because they may latch in a continuous reset loop, rendering them unusable.

    Product
    Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1323-2014·2014-04-09

    Teleflex Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports worldwide because they may leak insufflation gas during use.

    Product
    Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and accessori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2014·2014-03-26

    Philips HeartStart FR3 AED Recalled for Potential Circuit Board Separation

    Philips is recalling HeartStart FR3 AEDs because the circuit board may separate, preventing the device from delivering a shock during an emergency.

    Product
    Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS)
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1064-2014·2014-03-26

    Elekta Linear Accelerators Recalled for Default Value Reset Issues

    Elekta, Inc. is recalling SL & SLi Series linear accelerators because customers are resetting default values outside recommended factory settings.

    Product
    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2014·2014-03-26

    Philips Recalls HeartStart Home and OnSite AEDs Due to Solder Residue

    Philips is recalling HeartStart Home and OnSite AEDs because solder residue may prevent the device from delivering therapy in an emergency.

    Product
    Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2014·2014-03-19

    GE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues

    GE Healthcare is recalling CARESCAPE Monitor B650 and B850 units due to potential safety issues with Non-Invasive Blood Pressure and Bed to Bed functions.

    Product
    GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2014·2014-03-19

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Q-CPR Meter Display Error

    Philips is recalling HeartStart MRx Monitor/Defibrillators with the Q-CPR Meter option because the device may incorrectly display a 'Do Not Touch the Patient' icon during defibrillation mode.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 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 op
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2014·2014-03-19

    Smith & Nephew RENASYS Soft Port Dressing Kits Recalled for Sealing Defects

    Smith & Nephew is recalling RENASYS Soft Port Dressing Kits because inadequate sealing may prevent wound fluid evacuation and fail to trigger pump alarms.

    Product
    Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1163-2014·2014-03-19

    GE Healthcare Recalls Innova X-ray Systems for Unexpected Power Loss

    GE Healthcare is recalling Innova cardiovascular X-ray systems because they may unexpectedly stop delivering X-rays, causing a loss of real-time imaging.

    Product
    GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2014·2014-03-12

    Phillips Respironics Recalls Trilogy Ventilators Due to Power Board Defect

    Phillips Respironics is recalling 572 Trilogy ventilators worldwide because a defective power management board component may cause loss of therapy.

    Product
    Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0951-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Hazard

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1090-2014·2014-03-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for ESD Component Damage

    Philips is recalling HeartStart MRx Monitor/Defibrillators because a processor board component may be damaged by electrostatic discharge, disrupting ECG and SpO2 functionality.

    Product
    HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC 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 i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0955-2014·2014-03-05

    Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2014·2014-03-05

    Elekta Recalls DMLC IV-ERGO Systems Due to Gantry Sensor Error

    Elekta, Inc. is recalling 35 DMLC IV-ERGO systems because an intermittent error may occur in the gantry sensor. The devices are used with linear accelerators for radiation therapy.

    Product
    DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2014·2014-03-05

    Fresenius Optiflux Dialyzers Recalled for Dialysate Port Leak During Priming

    Fresenius Medical Care is recalling Optiflux F160NRe dialyzers because the dialysate port may leak during priming. The recall covers 3.4 million units distributed in the US and Mexico.

    Product
    Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2014·2014-03-05

    Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk

    Teleflex Medical is recalling specific lots of ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising airway maintenance.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1000-2014·2014-02-26

    Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2014·2014-02-19

    Boston Scientific Recalls Coyote PTA Balloon Dilatation Catheters

    Boston Scientific is recalling Coyote PTA Balloon Dilatation Catheters because the balloons may not deflate as expected during procedures.

    Product
    Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0969-2014·2014-02-19

    Boston Scientific Recalls Coyote Balloon Dilation Catheters Due to Deflation Issues

    Boston Scientific is recalling specific lots of Coyote balloon dilation catheters because the balloons may not deflate as expected during procedures.

    Product
    Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0918-2014·2014-02-12

    Edwards Lifesciences Recalls 26mm Transcatheter Heart Valve Crimpers

    Edwards Lifesciences is recalling two lots of 26mm transcatheter heart valve crimpers because they may not open fully, potentially preventing proper valve preparation.

    Product
    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 409 units of Codman Certas Programmable Valves because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cereb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2014·2014-02-05

    Spacelabs AriaTelemetry Transmitters Recalled for SpO2 Display Errors

    Spacelabs is recalling AriaTelemetry transmitters because they may display SpO2 values when sensors are disconnected or failed.

    Product
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2014·2014-01-15

    Fresenius 2008 Series Hemodialysis Machines Recalled for Saline Bag Filling Issues

    Fresenius Medical Care is recalling 2008 Series Hemodialysis Machines because saline bags may fill inappropriately during setup and recirculation.

    Product
    Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0603-2014·2014-01-08

    Terumo Cardiovascular Procedure Kits Recalled Due to Uncleared Safety Valve

    Terumo is recalling 24,227 Custom Cardiovascular Procedure Kits because the Overpressure Safety Valve used in the arterial line was not cleared for that specific use.

    Product
    Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
    Category
    Medical Device
    Distribution
    Distributed nationwide