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.

951–975 of 1800

  • SevereFDA (Devices)·Z-2056-2020·2020-06-03

    Heartware Recalls HVAD Pump Implant Kits Due to Graft Tears and Screw Breakage

    Heartware, Inc. is recalling 2,225 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant assembly.

    Product
    Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2157-2020·2020-06-03

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Missing Field Action Corrections

    Philips is recalling 260 HeartStart MRx Monitor/Defibrillators because some units may not have received required corrections from prior field actions.

    Product
    Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2020·2020-06-03

    Philips HeartStart XL Monitor/Defibrillators Recalled for Missing Field Action Corrections

    Philips is recalling 130 HeartStart XL Monitor/Defibrillators because they may not have received required corrections from prior field actions.

    Product
    Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1953-2020·2020-05-20

    Cardiac Assist Recalls Six TandemHeart Pump Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling six TandemHeart pump kits because an assembly error may prevent the device from priming.

    Product
    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2020·2020-05-20

    Cardiac Assist Recalls 13 TandemLife Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 13 TandemLife Kits because an assembly error may prevent the pump from priming. The kits provide temporary circulatory support.

    Product
    TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2020·2020-05-20

    Intuitive Surgical Recalls da Vinci X Systems Due to Arm Fault

    Intuitive Surgical is recalling 74 da Vinci X Surgical Systems because a manufacturing variation in the arm can cause a fault error and loss of functionality during surgery.

    Product
    da Vinci X Surgical System
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1951-2020·2020-05-20

    Cardiac Assist Recalls 38 TandemHeart ProtekDuo Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 38 TandemHeart ProtekDuo Kits because an assembly error may prevent the pump from priming.

    Product
    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2020·2020-05-20

    Cook Inc. Recalls Formula 418 Renal Balloon-Expandable Stents

    Cook Inc. is recalling 10 Formula 418 Renal Balloon-Expandable Stents because the stent may dislodge from the delivery system before deployment.

    Product
    Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. Th
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1843-2020·2020-05-13

    Philips TEE Transducers Recalled Due to Temperature Measurement Failure

    Philips Ultrasound Inc is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.

    Product
    Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocard
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1905-2020·2020-05-13

    Medtronic Recalls Visualase Cooled Laser Applicator System Tubing Sets

    Medtronic is recalling Visualase Cooled Laser Applicator System tubing sets due to assembly defects that may disrupt saline flow.

    Product
    Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1844-2020·2020-05-13

    Philips S8-3t Transesophageal Ultrasound Transducers Recalled for Temperature Measurement Failure

    Philips is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.

    Product
    Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2020·2020-05-13

    Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Failure

    Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a manufacturing programming error prevents the system from correctly measuring tip temperature, which may stop auto-cooling and cause patient injury.

    Product
    Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1805-2020·2020-05-06

    Obalon Balloon System Recalled Due to Touchscreen Calibration Issues

    Obalon Therapeutics is recalling 45 Obalon Balloon Systems because the touchscreen may lose calibration, preventing balloon inflation.

    Product
    Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1738-2020·2020-04-29

    Boston Scientific Recalls Stretch VL Ureteral Stent Sets

    Boston Scientific is recalling 50 units of Stretch VL Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2020·2020-04-29

    Boston Scientific Recalls Polaris Ultra Ureteral Stent Sets

    Boston Scientific is recalling 19 Polaris Ultra Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.

    Product
    Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2020·2020-04-29

    Boston Scientific Recalls Sensor Nitinol Wire Due to Tracking Issues

    Boston Scientific is recalling specific lots of Sensor Nitinol Wire with Hydrophilic Tip because increased complaints indicate difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2020·2020-04-29

    Boston Scientific Recalls Percuflex Plus Ureteral Stent Sets Due to Tracking Issues

    Boston Scientific is recalling 5 units of Percuflex Plus Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.

    Product
    Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2020·2020-04-29

    Boston Scientific Recalls Percuflex Plus Ureteral Stent Sets

    Boston Scientific is recalling 91 Percuflex Plus Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2020·2020-04-29

    Boston Scientific Recalls Contour VL Ureteral Stent Sets

    Boston Scientific is recalling Contour VL Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.

    Product
    Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2020·2020-04-29

    Boston Scientific Recalls Sensor Nitinol Wires Due to Tracking Issues

    Boston Scientific is recalling Sensor Nitinol Wires because an increased rate of complaints indicates difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1755-2020·2020-04-29

    Radiometer TCM4 Base Unit Recalled for Display Flickering and Unresponsiveness

    Radiometer Medical ApS is recalling 84 TCM4 Base units due to reports of display flickering and unresponsiveness, which may delay patient monitoring.

    Product
    TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1729-2020·2020-04-29

    Boston Scientific Recalls Sensor Nitinol Wire Due to Tracking Issues

    Boston Scientific is recalling Sensor Nitinol Wires with Hydrophilic Tips because an increased rate of complaints indicates difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1739-2020·2020-04-29

    Boston Scientific Recalls Stretch VL Ureteral Stent Sets Due to Tracking Issues

    Boston Scientific is recalling 40 units of Stretch VL Ureteral Stent Sets because they may be difficult to track over a guidewire, potentially delaying procedures.

    Product
    Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1734-2020·2020-04-29

    Boston Scientific Recalls Percuflex Plus Ureteral Stent Sets

    Boston Scientific is recalling 32 Percuflex Plus Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2020·2020-04-29

    Boston Scientific Recalls Sensor Nitinol Wire with Hydrophilic Tip

    Boston Scientific is recalling 225 units of Sensor Nitinol Wire with Hydrophilic Tip due to increased complaints about difficulty tracking over the guidewire.

    Product
    Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
    Category
    Medical Device
    Distribution
    Distributed nationwide