The Recall Desk

Hazard

Malfunction recalls

229 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
229
Critical
2
Severe
20
Most recent
2026-09-02

Of the 229 malfunction recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (9%) 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 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.

101–125 of 229

  • ModerateFDA (Devices)·Z-0897-2018·2018-03-14

    Boston Scientific Recalls Two Auriga 30 Laser Systems for Assembly Defect

    Boston Scientific is recalling two Auriga 30 Laser Systems because incorrectly assembled trigger wires may cause error codes or failure to start the console.

    Product
    Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0898-2018·2018-03-14

    Boston Scientific Recalls Auriga XL 4007 Laser Systems Due to Assembly Defect

    Boston Scientific is recalling nine Auriga XL 4007 Laser Systems because incorrectly assembled trigger wire components may cause error codes or prevent the consoles from starting.

    Product
    Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0728-2018·2018-03-07

    Perkinelmer Recalls Janus Automated Workstations Due to Circuit Board Defect

    Perkinelmer is recalling seven Janus and Janus G3 automated workstations because defective circuit boards may cause horizontal motion errors and instrument downtime.

    Product
    JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0492-2018·2018-02-07

    Tosoh AIA-900 Sorters Recalled for Potential Photo Interrupter Malfunction

    Tosoh Bioscience Inc is recalling AIA-900 9tray and 19tray Sorters due to a potential malfunction of the photo interrupter caused by aging.

    Product
    Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0491-2018·2018-02-07

    Tosoh AIA-900 Analyzer Recalled for Photo Interrupter Malfunction

    Tosoh Bioscience Inc is recalling 565 AIA-900 Automated Enzyme Immunoassay Analyzers due to a potential malfunction of the photo interrupter caused by aging.

    Product
    Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2018·2018-01-24

    Phadia 1000 Instrument Recalled Due to Retry Command Malfunction

    Phadia US Inc is recalling 70 Phadia 1000 Instruments nationwide because a malfunctioning Retry command may cause solution shortages and affect test results.

    Product
    Phadia 1000 Instrument, Article Number 12-3800-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18057·2017-12-11

    Ravin Crossbows Recalls Arrow Nocks Due to Injury Hazard

    Ravin Crossbows is recalling approximately 220,000 white plastic arrow nocks because they may malfunction, posing an injury hazard to users.

    Product
    Ravin arrow nocks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2705-2017·2017-07-19

    O-Two Adult Ventilation Timer Recalled Due to Flash Rate Malfunction

    O-Two Medical Technologies is recalling Adult Ventilation Timers because the flash rate may be twice the labeled rate, potentially affecting ventilation guidance.

    Product
    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2048-2017·2017-05-17

    Zimmer CAS Recalls NDI P7 Position Sensors for Potential Malfunction

    Zimmer CAS is recalling 34 NDI P7 Position Sensors due to a manufacturing issue that may cause them to stop functioning during use.

    Product
    NDI P7 Position Sensor, Stereotaxic Instrument
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1499-2017·2017-03-29

    Stanley Security Recalls 500 Arial Wireless Call Pendants

    Stanley Security Solutions is recalling 500 Arial Wireless Water-Resistant Call Pendants because they were incorrectly programmed, which may prevent alarms from sounding when the button is pressed.

    Product
    Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1401-2017·2017-03-15

    Boston Scientific Recalls AngioJet Ultra 5000 A Console Foot Switches

    Boston Scientific is recalling AngioJet Ultra 5000 A Console foot switches because they may stick during use, causing the device to operate continuously and undesirably.

    Product
    AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, to
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1218-2017·2017-02-22

    Aesculap GN200 Caiman HF Generators Recalled for Faulty Component

    Aesculap Implant Systems LLC is recalling 24 GN200 Caiman HF generators due to a faulty component that may impact proper device functioning.

    Product
    GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1143-2017·2017-02-15

    Physio-Control Recalls LIFEPAK 12 Defibrillators with Erratic CO2 Readings

    Physio-Control is recalling LIFEPAK 12 Defibrillators because the End-Tidal CO2 reading may intermittently display an invalid value of XXX during operation.

    Product
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1101-2017·2017-02-01

    PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures

    PerkinElmer is recalling AutoDELFIA systems with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1102-2017·2017-02-01

    PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures

    PerkinElmer is recalling AutoDELFIA systems with V3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0603-2017·2016-11-23

    Siemens AXIOM Artis Angiographic X-ray Systems Recalled for Footswitch Defect

    Siemens is recalling AXIOM Artis angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

    Product
    AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures tha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0602-2017·2016-11-23

    Siemens Artis zee/zeego Angiographic X-ray Systems Recalled for Footswitch Defect

    Siemens is recalling Artis zee/zeego angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

    Product
    Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0601-2017·2016-11-23

    Siemens Artis Q Angiographic X-ray System Recalled for Footswitch Defect

    Siemens is recalling 4,657 Artis Q angiographic x-ray systems because the semi-automatic focus switch may not work as intended when the footswitch is pressed multiple times.

    Product
    Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2017·2016-10-26

    Synergetics Recalls 25 Gauge VersaVit 2.0 Vitrectomy Cutters

    Synergetics Inc is recalling 25 gauge VersaVit 2.0 Vitrectomy Cutters because they may not operate within the correct pressure pulse specifications.

    Product
    25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Devices)·Z-0001-2017·2016-10-12

    Terumo CDI H/S Cuvette Recall Due to Connection Error

    Terumo is recalling CDI H/S Cuvettes because they may fail to connect to the probe, causing the monitor to display an error and preventing blood parameter display.

    Product
    CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2690-2016·2016-09-07

    Fujifilm Digital Mammography System Recalled for Biopsy Workflow Error

    Fujifilm is recalling two Aspire HD Digital Mammography Systems because an aborted stereo biopsy may cause an error that prevents the system from operating properly.

    Product
    FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2644-2016·2016-08-31

    Ziehm Vision2 Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling two Ziehm Vision2 mobile C-arm devices because the radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.

    Product
    Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2642-2016·2016-08-31

    Ziehm Vision R Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling one Ziehm Vision R Mobile C-arm device because its radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.

    Product
    Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2643-2016·2016-08-31

    Ziehm Solo Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling 12 Ziehm Solo Mobile C-arms because the radiation-warning timer and 3D-specific interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2396-2016·2016-08-17

    Stryker Recalls Exeter Rasp Handle Due to Malfunctioning

    Stryker Howmedica Osteonics Corp. is recalling 241 Exeter Rasp Handles because they may malfunction during use.

    Product
    Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle i
    Category
    Medical Device
    Distribution
    Distributed nationwide