The Recall Desk

Hazard

Software Defect recalls

1,332 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,332
Critical
14
Severe
91
Most recent
2026-09-02

Of the 1,332 software defect recalls we have scored against our rubric, 14 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 91 (7%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software defect 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.

226–250 of 1332

  • ModerateFDA (Devices)·Z-1387-2024·2024-04-03

    CareEvent Event Management System notification failure on locked iOS devices

    The CareEvent Event Management System's Care Assist mobile application fails to play custom ringtones when iOS device screens are locked with a passcode. This may result in missed alerts or notifications.

    Product
    CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2024·2024-03-20

    Ivenix Infusion System Software Defect May Delay or Cause Incorrect Infusions

    Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.

    Product
    LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2024·2024-03-20

    Infusion Pump Software Defect Causes Incorrect Alarm and Therapy Delay

    Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.

    Product
    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2024·2024-03-13

    Medical Device: VITROS 3600 immunodiagnostic system software defect may produce incorrect results

    A software defect in the VITROS 3600 Immunodiagnostic System may cause quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient test results.

    Product
    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2024·2024-03-13

    VITROS 5600 Diagnostic System Software Defect May Cause Erroneous Lab Results

    A software defect in VITROS 5600 Systems prevents quality control baseline statistics from updating properly, which may cause erroneous patient test results to be reported.

    Product
    VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2024·2024-03-13

    VITROS 4600 Chemistry System Software Defect Affects Quality Control Reporting

    A software defect in VITROS 4600 Chemistry Systems running software versions 3.8.0 or 3.8.1 prevents quality control rules from being flagged or reported correctly, potentially allowing erroneous patient results to be released.

    Product
    VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2024·2024-03-13

    Synapse PACS version 7.3.000 produces incorrect breast imaging measurements

    FUJIFILM's Synapse PACS version 7.3.000 software produces incorrect measurements when secondary capture images without pixel spacing are combined with breast tomosynthesis series. No illnesses or injuries reported.

    Product
    Synapse PACS - Version 7.3.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2024·2024-03-13

    Medical device software defect may cause incorrect laboratory test results

    A software defect in VITROS XT 7600 diagnostic systems running version 3.8.1 causes quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient laboratory results.

    Product
    VITROS XT 7600 Integrated System, Catalog No. 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2024·2024-03-13

    Laboratory analyzer software defect may cause erroneous patient test results

    A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.

    Product
    VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2024·2024-03-13

    Laboratory chemistry system software defect impairs quality control reporting

    A software defect in VITROS XT 3400 Chemistry Systems prevents quality control rules from properly reporting failures in test controls. This may result in erroneous patient test results being reported.

    Product
    VITROS XT 3400 Chemistry System, Catalog No. 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2024·2024-03-13

    Medical Device Recall: VITROS XT 3400 Chemistry System Software Defect

    Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.

    Product
    VITROS XT 3400 Chemistry System, Catalog No. 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2024·2024-03-13

    VITROS Diagnostic System Software Defect May Cause Erroneous Patient Results

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 systems with software defects in versions 3.8.0 and 3.8.1. The defect prevents quality control rules from being properly reported, which could cause erroneous patient test results.

    Product
    VITROS XT 7600 Integrated System, Catalog No. 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2024·2024-03-13

    VITROS 5600 Diagnostic System Software Defect Prevents Quality Control Flagging

    Ortho-Clinical Diagnostics is recalling VITROS 5600 diagnostic systems (software versions 3.8.0 or 3.8.1) due to a defect that prevents quality control alerts from displaying, potentially allowing erroneous patient test results to be reported.

    Product
    VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2024·2024-03-13

    Medical Device Software Defect May Cause Erroneous Lab Results

    A software defect in VITROS 3600 Immunodiagnostic Systems (versions 3.8.0 and 3.8.1) prevents quality control rules from reporting failures as expected, potentially allowing invalid test results to be reported.

    Product
    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V149000·2024-02-26

    LiveWire S2 Del Mar software may shut down the powertrain

    LiveWire is recalling certain 2024 S2 Del Mar motorcycles because the Vehicle Supervisory Control software may initiate a powertrain shutdown. 523 units are affected.

    Product
    LIVEWIRE — LIVEWIRE S2 DEL MAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V133000·2024-02-22

    Chevrolet Colorado and GMC Canyon may brake automatically without an obstacle

    GM is recalling certain 2023 Chevrolet Colorado and GMC Canyon vehicles because the front camera module may falsely detect an obstacle and engage automatic emergency braking unexpectedly.

    Product
    CHEVROLET — CHEVROLET, GMC COLORADO, CANYON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V134000·2024-02-22

    Jaguar I-Pace turn signal flash rate does not warn of failure

    Jaguar is recalling certain 2021-2024 I-Pace vehicles because the turn signal flash rate will not change to warn the driver that a turn signal has stopped working, failing FMVSS 108.

    Product
    JAGUAR — JAGUAR I-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V125000·2024-02-21

    Toyota Tundra and Lexus LX may move unexpectedly in neutral

    Toyota is recalling certain 2022-2024 Tundra, Tundra Hybrid, Lexus LX600 and 2023-2024 Sequoia Hybrid vehicles because unexpected vehicle movement may occur in neutral without the brakes applied.

    Product
    TOYOTA — TOYOTA, LEXUS TUNDRA, LX, TUNDRA HYBRID, SEQUOIA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V124000·2024-02-21

    Lexus and Toyota Mirai rearview camera images may not display promptly

    Toyota is recalling certain Lexus and Toyota Mirai vehicles with a Panoramic View Monitor because the rearview camera image may not display immediately after shifting into reverse.

    Product
    TOYOTA — TOYOTA, LEXUS MIRAI, LC HYBRID, ES HYBRID, LC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0842-2024·2024-02-14

    HeartMate Touch Communication System recalled for software pump operation defects

    Thoratec Corp. is recalling HeartMate Touch Communication Systems (1,560 units) due to software and controller defects causing unexpected LVAD pump starts or stops, potentially affecting patient safety.

    Product
    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2024·2024-02-14

    Philips Spectral CT software issue causes image mislabeling

    A software defect in Philips Spectral CT on Rails affects image labeling, potentially leading to patient misdiagnosis and incorrect treatment. This FDA Class II recall affects one unit distributed across multiple U.S. states and internationally.

    Product
    Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24E013000·2024-02-13

    Waymo Recalls 5th Generation Automated Driving Systems for Software Defect

    Waymo is recalling 5th Generation Automated Driving Systems with software released before December 20, 2023, because the systems may inaccurately predict the movement of towed vehicles.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2024·2024-02-07

    Azurion 7 M20 Imaging System Recalled for Loss of Arm and Table Movement

    Philips Azurion 7 M20 FlexArm systems may lose connectivity due to a date/time software issue, preventing arm and table movement. The defect affects 108 systems worldwide, including 14 in the United States.

    Product
    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V068000·2024-02-02

    Blue Bird Recalls 2021-2024 Vision School Buses for Stop Arm Defect

    Blue Bird is recalling 2021-2024 Vision school buses because a software defect may cause warning lights to turn off and the stop arm to retract unexpectedly.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide