The Recall Desk

Hazard

Software Defect recalls

1,375 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,375
Critical
14
Severe
106
Most recent
2026-10-21

Of the 1,375 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 106 (8%) 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.

351–375 of 1375

  • HighFDA (Devices)·Z-0151-2023·2022-11-09

    Boston Scientific EMBLEM S-ICD Subcutaneous Defibrillators Software Defect Causes Battery Display Error

    Boston Scientific is recalling 7 EMBLEM S-ICD Model A209 subcutaneous defibrillators due to a software defect that displays inaccurate battery capacity information. Patients may not realize when their device's battery requires replacement.

    Product
    EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0152-2023·2022-11-09

    Implantable Defibrillator Software Error Causes Inaccurate Battery Display

    Boston Scientific's EMBLEM MRI S-ICD implantable defibrillators contain a software defect with an incorrect manufacturing date that causes inaccurate battery capacity display. The recall affects 142 devices distributed worldwide.

    Product
    EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2023·2022-11-02

    ARTIS pheno interventional x-ray system software defect prevents treatment continuation

    Siemens is recalling ARTIS pheno x-ray systems with VE10B software due to three potential software issues that may prevent continued treatment on the affected system, potentially requiring use of an alternate system.

    Product
    ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V781000·2022-10-18

    Harley-Davidson Touring and Trike Motorcycles Unintended Brake Light Illumination Recall

    Harley-Davidson is recalling certain 2019-2022 Touring, Trike, and CVO models due to a software error causing brake lights to illuminate without rider input. This malfunction may confuse other drivers and increase crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FLTRXS, FLTRXSE, FLTRXST, FLHTCUTGSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V710000·2022-09-22

    2023 Cadillac LYRIQ Instrument Panel Software Error May Cause Display to Go Blank

    General Motors is recalling certain 2023 Cadillac LYRIQ vehicles due to a software error that may cause the instrument panel display to go blank, potentially preventing drivers from seeing critical safety information.

    Product
    CADILLAC — CADILLAC redundant LYRIQ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2022·2022-09-07

    Eye imaging device software defect affects surgical planning calculations

    Pentacam eye imaging devices with certain software versions have a bug that causes inaccurate surgical planning printouts for toric intraocular lens procedures.

    Product
    Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1639-2022·2022-09-07

    AggreGuide A-100 Instrument Software Issue Affecting Test Results

    Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument due to a software design defect that causes the device to run assays at 0 RPM, resulting in no blood mixing and inaccurate test results displayed as Low.

    Product
    AggreGuide A-100 Instrument
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22E072000·2022-08-29

    Cruise Recalls Automated Driving System Software for Left Turn Prediction Errors

    Cruise LLC is recalling Automated Driving System units with specific software versions that may incorrectly predict vehicle paths during unprotected left turns, increasing crash risk.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2022·2022-08-17

    Roche cobas e801 Analyzer Recall: Software Defect Affects Test Results

    Roche is recalling approximately 965 cobas e801 Immunoassay Analyzers nationwide due to a software issue that impacts Pre-Wash test signals and results for six diagnostic assays. No injuries or illnesses have been reported.

    Product
    cobas e801 Immunoassay Analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2022·2022-08-17

    Xhibit Telemetry Receiver Model 96280 alarm escalation software defect

    Xhibit Telemetry Receiver Model 96280 units fail to escalate critical alarms after approximately 25 days of continuous use, including signal loss, low battery, and SpO2 sensor issues. Caregivers may not be aware of device failures.

    Product
    Xhibit Telemetry Receiver, Model: 96280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2022·2022-08-10

    Merlin 2 PCS MER3400 programmer software recalled by St. Jude Medical

    St. Jude Medical recalled Merlin 2 PCS MER3400 programmer software version 1.1.2 revision 1 or earlier in an FDA Class II recall. The recall affects 622 units distributed across the United States and internationally.

    Product
    Merlin 2 PCS MER37000 programmer Model MER3400 software
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-1495-2022·2022-08-10

    Pacemaker Programmer Software May Display Overestimated Battery Longevity

    St. Jude Medical's Merlin PCS 3650 programmer software may display overestimated predicted battery longevity for certain pacemakers. This could affect clinical decision-making regarding device maintenance and replacement timing.

    Product
    Merlin PCS 3650 programmer Model 3330 software
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-1466-2022·2022-08-03

    GE Centricity PACS Software fails to notify of exam study modifications

    GE Healthcare's Centricity PACS software version 7.0 SP0.0.4.7 does not alert users when previously verified imaging studies are modified, potentially causing clinicians to use outdated or changed data without awareness.

    Product
    Centricity PACS Software Version 7.0 SP0.0.4.7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2022·2022-07-27

    Radiation treatment planning software fails to propagate treatment course data

    RayStation 9B SP1 radiation treatment planning software has an issue where treatment course information may not be propagated to other systems in some workflows. This could potentially affect treatment planning accuracy.

    Product
    RayStation 9B SP1. For radiation treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2022·2022-07-27

    Sensis Vibe Combo Device Recalled for Software Communication Failure

    The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.

    Product
    Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V508000·2022-07-15

    Isuzu Recalls 2022 FTR and FVR Trucks Due to Engine Braking Defect

    Isuzu is recalling 2022 FTR and FVR trucks because a software error disables engine braking, potentially increasing stopping distances and crash risk.

    Product
    ISUZU — ISUZU FTR, FVR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2022·2022-06-22

    Medtronic Cobalt ICD and CRT-D Telemetry Software Error Recall

    Medtronic is recalling Cobalt and Crome ICDs and CRT-Ds due to a software telemetry error in the CareLink SmartSync Device Manager. The error may affect device communication and remote monitoring.

    Product
    Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2022·2022-06-15

    Medical imaging software measurement accuracy error in Centricity PACS RA1000

    GE Healthcare's Centricity PACS RA1000 medical imaging software may display inaccurate distance and area measurements on magnified or scaled images, potentially affecting diagnostic accuracy.

    Product
    Centricity PACS RA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2022·2022-06-15

    Medical imaging software may display inaccurate measurement values

    GE Healthcare's Centricity Universal Viewer Zero Footprint Client may display inaccurate distance and area measurements on magnified or scaled images.

    Product
    Centricity Universal Viewer Zero Footprint Client
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2022·2022-06-08

    Bio-Rad Sickle Cell Testing Software CD-ROM Defect Overwrites Custom Settings

    Bio-Rad is recalling Resin Update CD-ROM software (Model 250-3020) for the VARIANT nbs Sickle Cell Program because the update procedure overwrites custom laboratory settings, potentially causing incorrect pattern assignment in tested samples.

    Product
    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
    Category
    Medical Device
    Distribution
    24 states
  • HighNHTSA·22V382000·2022-05-27

    Ford Recalls 2019-2020 Mustangs for Software Defect Affecting Safety Features

    Ford is recalling 25,032 2019-2020 Mustangs with 5.0L engines and manual transmissions because a software defect may disable the reverse camera, reverse light, and driver assist features, increasing crash risk.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V360000·2022-05-20

    Daimler Recalls 2019-2021 Sprinter Vehicles for eCall Software Defect

    Daimler Vans USA is recalling 2019-2021 Freightliner and Mercedes-Benz Sprinter vehicles because a software error may disable the emergency call system.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 4500, SPRINTER 2500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2022·2022-05-18

    VITEK 2 Systems Software Issue May Produce Incorrect Antibiotic Test Results

    bioMerieux VITEK 2 bacterial identification systems have a software defect where antibiotic susceptibility and synergy test results transmitted to laboratory systems may omit user or automated corrections, potentially leading to incorrect test interpretation.

    Product
    VITEK 2 Systems and VITEK 2 with MYLA.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1074-2022·2022-05-18

    Phototherapy Units Recalled for Software Bug Causing Incorrect Dosing

    Daavlin's 4 Series CX phototherapy units are recalled due to a software defect that can cause incorrect dosing (over or under) when resuming interrupted treatments.

    Product
    4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.
    Category
    Medical Device
    Distribution
    Distributed nationwide