The Recall Desk

Hazard

Software Defect recalls

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

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.

51–75 of 316

  • HighFDA (Devices)·Z-0412-2026·2025-11-05

    Laboratory Sample Preparation System Software and Instructions with Processing Defects

    Beckman Coulter's CellMek SPS Sample Preparation System has incorrect dead volume specifications in its instructions and a software defect affecting specimen processing. The errors may lead to incorrect diagnoses or errors in patient management.

    Product
    CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2026·2025-10-29

    Clinical Analyzer Software Issue May Produce Incorrect Patient Test Results

    Beckman Coulter clinical laboratory analyzers have a software defect that may prevent correct application of dilution factors to patient samples, potentially producing false test results and diagnostic errors.

    Product
    DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2026·2025-10-29

    Tandem insulin pumps recalled for software defect causing unexpected insulin bolus

    Tandem Diabetes Care is recalling over 122,000 t:slim X2 and Mobi insulin pumps due to a software defect that may cause unexpected automatic insulin delivery, potentially leading to dangerously low blood sugar.

    Product
    t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0079-2026·2025-10-22

    Boston Scientific Recalls ACCOLADE Family Pacemakers for Safety Mode Software Defect

    Boston Scientific is recalling ACCOLADE pacemakers due to a software defect that may cause unintended Safety Mode activation when battery impedance is elevated. A software update is available to address this issue.

    Product
    ACCOLADE SR SL (Model L300)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0092-2026·2025-10-22

    Pacemaker Software Update to Prevent Inappropriate Safety Mode Activation

    Boston Scientific is issuing a software update for ESSENTIO and related pacemaker models to prevent inappropriate Safety Mode activation in ambulatory settings when battery impedance is high.

    Product
    Model Number L100, ESSENTIO SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0088-2026·2025-10-22

    Boston Scientific Pacemakers Software Update for Safety Mode

    Boston Scientific is issuing a software update for multiple pacemaker models to prevent unwanted Safety Mode activation due to high battery impedance in ambulatory settings. The update affects ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE models distributed worldwide.

    Product
    Model Number L210 PROPONENT SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0100-2026·2025-10-22

    Boston Scientific Pacemakers Software Issue Can Trigger Inappropriate Safety Mode

    Boston Scientific is recalling certain ACCOLADE family pacemakers, including ALTRUA 2 models, because a software issue can cause inappropriate Safety Mode activation in ambulatory settings. A software update is available to prevent this malfunction.

    Product
    Model Number S722, ALTRUA 2 DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0082-2026·2025-10-22

    Pacemakers Recalled Due to Software Defect in Safety Mode Activation

    Boston Scientific is recalling ACCOLADE and related pacemakers worldwide due to a software issue that may cause unintended Safety Mode activation in ambulatory settings when high battery impedance is detected.

    Product
    ACCOLADE DR SL MRI (Model L311)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0097-2026·2025-10-22

    Boston Scientific Pacemakers Software Update Required for Safety Mode Issue

    Boston Scientific pacemakers may experience inappropriate Safety Mode activation in ambulatory settings due to high battery impedance. Software to address this issue is available; contact your healthcare provider.

    Product
    Model Number L131, ESSENTIO DR EL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0098-2026·2025-10-22

    Pacemaker Software Defect Recall: Unintended Safety Mode Activation Risk

    Boston Scientific recalls certain pacemaker models that may unintentionally activate Safety Mode in ambulatory settings due to high battery impedance. Software is available to correct this defect.

    Product
    Model Number S701 ALTRUA 2 SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0157-2026·2025-10-22

    GE LOGIQ P9 Ultrasound System Software Displays Inaccurate Liver Steatosis Measurements

    GE Medical Systems is recalling 37 LOGIQ P9 R4.5 ultrasound systems because the UGAP measurement feature may display inaccurate values for liver steatosis, potentially leading to inappropriate clinical decisions.

    Product
    LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2639-2025·2025-10-08

    ZAP-X Radiosurgery System Software Defect May Cause Collision

    A software defect in the ZAP-X radiosurgery system could cause the collimator to collide with patient shoulders or the treatment table during certain gantry movements.

    Product
    ZAP-X Radiosurgery System, Model: 300150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V361000·2025-10-05

    2022-2024 Audi Q4 E-TRON Headlight Control Module Software Defect

    Volkswagen is recalling 2022-2024 Audi Q4 E-TRON and Q4 E-TRON Sportback vehicles for incorrect headlight control module software. This defect may prevent parking lights from operating correctly when headlights are on with turn signals activated, reducing visibility and increasing crash risk.

    Product
    AUDI — 2022 AUDI Q4 E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2570-2025·2025-09-24

    Pinnacle Radiation Therapy Planning System software ROI calculation error recall

    Pinnacle Radiation Therapy Planning System software contains a defect causing potential Region of Interest calculation errors in specific patient positioning modes. Philips is recalling 810 affected units for software correction.

    Product
    Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2025·2025-09-10

    RefleXion X1 radiation therapy system software configuration error causes excessive dose fractionation

    RefleXion X1 Model RXM1000 radiation therapy systems may deliver excessive radiation due to a software configuration error that allows more than two fractions in 12 hours, potentially causing toxicity.

    Product
    RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2025·2025-08-13

    Lab Immunoassay Analyzer Software Bug Delays Patient Result Reporting

    Beckman Coulter's DxI 600 Access Immunoassay Analyzer has a software defect causing incorrect motor current settings that may delay patient sample result reporting. The issue affects systems running software versions 5.7 and later.

    Product
    DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2266-2025·2025-08-13

    UniCel DxI 800 Analyzer Motor Current Settings Incorrectly Reset

    Beckman Coulter's UniCel DxI 800 analyzer has a software defect causing the motor current to reset to 1.5A instead of 2.0A during updates, potentially delaying patient sample reporting. Affected devices require remediation.

    Product
    UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V708000·2025-08-09

    Toyota Corolla Hybrid and Corolla Cross brake assist software defect

    A software defect in 2023-2025 Toyota Corolla vehicles may disable power brake assist while turning, extending stopping distance and increasing crash risk.

    Product
    TOYOTA — 2023 TOYOTA COROLLA CROSS HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V623000·2025-08-08

    2024 Fisker Ocean brake software defect reduces stopping distance

    Fisker is recalling 2023-2024 Ocean vehicles due to a brake module software issue that may reduce regenerative braking and stopping performance. The defect increases crash risk by extending stopping distance.

    Product
    FISKER — 2024 FISKER OCEAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2169-2025·2025-07-30

    Medtronic CareLink SmartSync Device Manager software abort button defect recall

    Medtronic is recalling CareLink SmartSync Device Manager software versions due to a defective abort button. The abort button does not properly stop induction testing, limiting users' ability to cancel high voltage therapy delivery.

    Product
    Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2168-2025·2025-07-30

    Medtronic CareLink SmartSync Devices Abort Button Software Defect Limits Therapy Cancellation

    Medtronic CareLink SmartSync Patient Connectors have a software defect where the Abort button operates only in a limited time window during induction tests, potentially preventing users from canceling high voltage therapy delivery.

    Product
    Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2096-2025·2025-07-23

    Baxter SIGMA Spectrum Infusion Pump Recall for Incorrect Software Version

    Baxter Healthcare is recalling 28 SIGMA Spectrum Infusion Pump V8 units due to incorrect software versions. Affected facilities should contact Baxter immediately.

    Product
    Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-2095-2025·2025-07-23

    Baxter Infusion Pump Recall: SIGMA Spectrum V6 Software Defect

    Baxter Healthcare recalls 14 SIGMA Spectrum Infusion Pump V6 units due to incorrect software version. The recalled units were distributed to 10 US states.

    Product
    Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2097-2025·2025-07-16

    Infinia Nuclear Medicine Systems Detector Motion Risk from Software Defect

    Certain Infinia nuclear medicine systems may experience unintended detector motion during patient setup or scanning if the gantry software is not up to date, potentially causing serious injury.

    Product
    Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
    Category
    Medical Device
    Distribution
    Distributed nationwide