The Recall Desk

Hazard

Software Failure recalls

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

What the numbers show

Total
42
Critical
0
Severe
4
Most recent
2026-08-26

Of the 42 software failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (10%) 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 software failure 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.

1–25 of 42

  • ModerateFDA (Devices)·Z-2951-2026·2026-08-26

    Foundation Medicine Recalls Hamilton Microlab STAR Liquid Handler Software

    Foundation Medicine is recalling 32 Hamilton Microlab STAR Liquid Handler units due to a software issue causing spontaneous closures.

    Product
    Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1354-2026·2026-02-25

    Olympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk

    Olympus is recalling 485 High Flow Insufflation Units (Model UHI-3) nationwide due to a software algorithm issue that may cause dangerous overpressure during abdominal surgery.

    Product
    Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1539-2025·2025-04-16

    Stryker Blueprint Mixed Reality Glenoid Box Lid system functionality issues

    Stryker is recalling the Blueprint Mixed Reality Glenoid Box Lid and related instrumentation kits due to elevated complaint rates. The product experiences software and instrumentation issues that prevent it from meeting its intended use.

    Product
    stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1534-2025·2025-04-16

    Stryker Blueprint Mixed Reality Glenoid Pin Guide Impaired Function Recall

    Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Glenoid Pin Guide due to elevated complaint rates regarding software and instrumentation functioning issues that prevent the product from meeting its intended use.

    Product
    stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0753-2025·2025-01-01

    Merlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing

    A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.

    Product
    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2025·2024-11-13

    Shimadzu FLUOROspeed X-ray System Software Recall for Image Display Failure

    Shimadzu is recalling 30 FLUOROspeed X-ray systems because software may fail to display images when switching modes, potentially delaying or canceling examinations.

    Product
    The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2582-2024·2024-08-28

    Spectrum Wireless Battery Modules fail to auto-document infusion status

    Spectrum Wireless Battery Modules may fail to send infusion status updates to hospital electronic medical records. The issue affects 17,377 units nationwide used with Spectrum V8 and IQ infusion pumps.

    Product
    Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0544-2024·2023-12-20

    FDA Recalls VITROS 4600 Chemistry System for Software-Related Freezes

    Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.

    Product
    VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2023·2023-07-05

    PushTracker E3 software failure may prevent stopping SmartDrive motor

    A software defect in the PushTracker E3 watch can cause the SmartDrive motor to run uncontrollably, and users may not be able to stop the device using tap controls. Approximately 6,196 units worldwide are affected.

    Product
    PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2004-2023·2023-07-05

    PushTracker E2 watch app may crash, disabling wheelchair motor controls

    Permobil's PushTracker E2 watch controls wheelchair power assist motors. The application may crash when running multiple processes, causing the motor to keep running and preventing users from stopping it using normal controls.

    Product
    PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0926-2023·2023-01-25

    Medical device controller software update addresses critical failure

    Cardiac Assist is issuing a software update for LifeSPARC Controller units that may experience critical failure causing the system to freeze, crash, or lose display functionality. Affected units are identified by specific serial numbers.

    Product
    SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22E016000·2022-03-03

    Pony.ai Recalls Automated Driving Systems Due to Software Shutdown Risk

    Pony.ai is recalling specific Automated Driving Systems (ADS) because a software error may cause the system to shut down unexpectedly while the vehicle is moving.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1863-2021·2021-06-30

    Nitric Oxide Delivery System Dosing Deficiency During Console Transitions

    GENOSYL DS Nitric Oxide Delivery System is recalled for delivering below-intended doses during transitions between primary and backup consoles following a software update.

    Product
    GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0612-2021·2020-12-23

    Medtronic Percept PC Neurostimulator Recall Due to Software Connection Failure

    Medtronic is recalling 12 Percept PC Implantable Neurostimulators because a software anomaly in the A620 Patient Programmer prevents connection to the device.

    Product
    Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2980-2020·2020-09-23

    Medtronic Guardian Connect iOS App Recall Due to Data Upload Failure

    Medtronic is recalling the Guardian Connect iOS app because a software update stopped automatic data uploads to the CareLink Personal website.

    Product
    The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1673-2020·2020-04-15

    Beckman Coulter LabPro Data Management System Software Update Recall

    Beckman Coulter is recalling 177 LabPro Data Management Systems because a security update caused some computers to fail to restart, potentially delaying microbiology test results.

    Product
    LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0222-2020·2019-11-06

    MedComp C3 Wave App Recalled Due to ECG Display Failure

    Medical Components, Inc dba MedComp is recalling the C3 Wave App v. 2.0.5 because it malfunctions on iOS 12, preventing ECG display during PICC procedures.

    Product
    C3 Wave App, v. 2.0.5
    Category
    Medical Device
    Distribution
    13 states
  • 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
  • ModerateFDA (Devices)·Z-2441-2019·2019-09-11

    Fujifilm FDR Go Plus X-ray System Recalled for Software Glitch

    Fujifilm is recalling 174 FDR Go Plus mobile X-ray systems because a graphics driver issue may cause the device to display a Blue Screen of Death.

    Product
    Fujifilm FDR Go Plus mobile X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1282-2019·2019-05-15

    Medtronic Guardian Connect App Recalled for Silent Operating System Shutdowns

    Medtronic is recalling the Guardian Connect App because the operating system may close it without warning, preventing users from receiving critical blood glucose alerts.

    Product
    Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0864-2019·2019-02-27

    Shimadzu TRINIAS Imaging Systems Recalled for Software and Display Errors

    Shimadzu is recalling 13 TRINIAS imaging systems due to software crashes and rare display corruption that may hinder medical examinations.

    Product
    TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0683-2019·2019-01-02

    Medtronic MiniMed Insulin Pumps Recalled for Missing Audio Alerts

    Medtronic is recalling specific MiniMed insulin pump models because software version 4.10 may fail to play expected audio sounds during alerts, alarms, or sirens.

    Product
    Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-0374-2019·2018-11-14

    GE Healthcare Recalls Centricity PACS-IW Software Due to Synchronization Failure

    GE Healthcare is recalling 13 units of Centricity PACS-IW software due to a synchronization failure that may affect the display of medical images.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0675-2018·2018-02-28

    Roche Cobas 8000 Modular Series Software Recall for Incorrect Results Risk

    Roche Diagnostics is recalling 399 Cobas 8000 Modular Series systems due to a software failure that may reset settings to defaults, creating a risk of incorrect test results.

    Product
    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
    Category
    Medical Device
    Distribution
    37 states