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.

1026–1050 of 1800

  • HighFDA (Devices)·Z-0589-2020·2019-12-18

    Cook Inc. Recalls CrossCath Support Catheters Due to Manufacturing Error

    Cook Inc. is recalling 43 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0610-2020·2019-12-18

    Smiths Medical Medfusion 4000 Syringe Pump Firmware Recall

    Smiths Medical is recalling 626 Medfusion 4000 Syringe Pumps due to a firmware anomaly that may disable battery alarms and interrupt therapy.

    Product
    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0602-2020·2019-12-11

    CooperSurgical Recalls Quantum 2000 Electrosurgical Generators Due to Malfunction

    CooperSurgical is recalling Quantum 2000 Electrosurgical Generators because they may stop cutting, coagulating, or blending during procedures when the foot pedal is used.

    Product
    Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0542-2020·2019-12-04

    Endotronix Recalls myCordella Patient Kits for Unexpected Power-Downs

    Endotronix is recalling 58 myCordella Patient Kits because the devices have been reported to power down without user interaction.

    Product
    myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0498-2020·2019-11-27

    Philips HeartStart XL+ Defibrillator Recall Due to Switch Failure

    Philips is recalling HeartStart XL+ Defibrillators because a faulty switch may cause the device to fail or deliver incorrect shock energy.

    Product
    HeartStart XL+ Defibrillator/Monitor, Model 861290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2020·2019-11-27

    Teleflex Recalls Hem-O-Lok AutoEndo5 Clip Appliers Due to Jamming

    Teleflex Medical is recalling 4,099 Hem-O-Lok AutoEndo5 clip appliers because they may jam or misload, potentially causing clips to fall out or break during surgery.

    Product
    WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2020·2019-11-27

    Cook Inc. Recalls Guardia Access Nano Embryo Transfer Catheters

    Cook Inc. is recalling 202 units of the Guardia Access Nano Embryo Transfer Catheter because bent tips may prevent insertion into the guiding catheter.

    Product
    Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0404-2020·2019-11-20

    Galil Medical Recalls Visual-ICE Cryoablation Systems Due to Needle Clogging

    Galil Medical is recalling 49 Visual-ICE Cryoablation Systems because the needles may clog or fail to freeze tissue adequately.

    Product
    Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-0371-2020·2019-11-20

    Avanos Medical Recalls CORFLO PEG Kits Due to Connector Defect

    Avanos Medical is recalling CORFLO PEG Kits because the connector piece does not pass over the guidewire. The recall affects 104 cases distributed to six US states and Great Britain.

    Product
    CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0345-2020·2019-11-13

    Abiomed lmpella CP Pump Recalled for Incorrect Programming and Disabled Alarms

    Abiomed is recalling one lmpella CP pump with Smart Assist due to incorrect programming that disabled safety alarms and altered pump operation.

    Product
    lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0341-2020·2019-11-13

    Western Grab n Go Opti VIPR System Recalled for Control Knob Defect

    Western / Scott Fetzer Company is recalling 6,790 Grab n Go Opti series VIPR systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0221-2020·2019-11-06

    Thoratec CentriMag Motor Recalled Due to Electromagnetic Interference Issues

    Thoratec is recalling CentriMag Acute Circulatory Support System motors due to reports of motor and pump issues caused by electromagnetic interference.

    Product
    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2020·2019-11-06

    Eversense CGM Sensors Recalled for Premature Function Failure

    Senseonics is recalling 1,344 Eversense CGM sensors nationwide because they may stop working early due to inadequate hydration of the glucose-sensing surface.

    Product
    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0246-2020·2019-11-06

    FDA Recalls Thorecon Plating System Kits Due to Molding Defect

    Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.

    Product
    A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0244-2020·2019-11-06

    Alto Development Recalls Thorecon Plating System Kits Due to Molding Defect

    Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.

    Product
    A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0243-2020·2019-11-06

    A&E Medical Thorecon Plating System Kits Recalled for Molding Defect

    Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.

    Product
    A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0160-2020·2019-10-30

    Siemens Mammomat Revelation Recall for Biopsy Software Error

    Siemens is recalling Mammomat Revelation mammography systems with specific software due to a rare error that can make the workstation unresponsive during biopsies.

    Product
    Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2020·2019-10-23

    Medtronic Euphoria Balloon Catheters Recalled for Stylette Removal Difficulties

    Medtronic is recalling Euphoria Rapid Exchange Balloon Dilatation Catheters because a slightly higher diameter stylette causes removal difficulties.

    Product
    Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0154-2020·2019-10-23

    Vital Scientific Viva-JR Automated Chemistry Analyzer Recalled for Power Supply Failure

    Vital Scientific N.V. is recalling four Viva-JR automated chemistry analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.

    Product
    Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2019·2019-10-09

    WOM Aquilex Fluid Control System Bag Deflector Recalled for Pump Deficit Error

    WOM World of Medicine AG is recalling Aquilex Fluid Control System bag deflectors because the pump's displayed deficit may differ from the actual deficit, posing a potential risk to patients.

    Product
    Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2558-2019·2019-10-02

    V-Twin Automated Chemistry Analyzer Recalled for Software Lockup

    Vital Scientific N.V. is recalling two V-Twin automated chemistry analyzers in New York because a software lockup prevents the instruments from producing patient results.

    Product
    V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinic
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2541-2019·2019-09-25

    Wilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Misassembly

    Wilson-Cook Medical Inc. is recalling 160 units of Hemospray Endoscopic Hemostat because misassembly may prevent the device from spraying powder.

    Product
    Hemospray Endoscopic Hemostat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2019·2019-09-25

    Maquet Cardiopulmonary Sets Recalled Due to Incorrect Quick Connector Assembly

    Maquet is recalling 54 cardiopulmonary sets because quick connectors were assembled in reverse, preventing proper priming and function.

    Product
    Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
    Category
    Medical Device
    Distribution
    17 states