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.

301–325 of 1332

  • HighNHTSA·23V040000·2023-02-01

    2021 Volkswagen ID.4 Software Defect May Cause Loss of Drive Power

    Volkswagen is recalling 2021 ID.4 vehicles because a software defect in the battery management system may cause loss of drive power, increasing the risk of a crash. Free software updates will be provided by dealers.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2023·2023-01-18

    Medical device software bug may cause patient sample order mismatches in rare cases

    A software bug in Roche Diagnostics' cobas infinity central lab may cause orders to be mismatched to wrong patient samples under rare circumstances. The issue affects 224 US units and 2,797 devices worldwide.

    Product
    cobas infinity central lab, Material Number 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V007000·2023-01-16

    Peterbilt 579 and Kenworth T680 electronic stability control software defect

    PACCAR is recalling approximately 46 Peterbilt 579 (2022-2023) and Kenworth T680 (2023) vehicles with faulty electronic stability control software that may underestimate vehicle mass, reducing crash prevention performance. Dealers will provide a free software update.

    Product
    KENWORTH — KENWORTH, PETERBILT T680, 579
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2023·2022-12-28

    Medical Imaging Software Update May Hide Patient Studies

    After installing the IAS tool, Centricity PACS-IW Universal Viewer version 5.0 may hide some medical imaging studies without notification. Accessing hidden studies requires GE Healthcare assistance and may cause diagnostic delays.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0268-2023·2022-11-30

    Diagnostic System Software Defects Affecting Sample Processing and Test Accuracy

    Abbott is recalling 883 Alinity m diagnostic systems due to software defects affecting sample identification, system operation, and test calibration. The issues affect all serial numbers running software version 1.6.5.

    Product
    Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V853000·2022-11-18

    Midwest Fire Recalls 2021-2022 All-Poly Series Fire Trucks

    Midwest Fire is recalling 2021-2022 All-Poly Series fire trucks because a software defect may prevent shifting between road and pump modes, potentially delaying emergency response.

    Product
    MIDWEST FIRE — MIDWEST FIRE ALL-POLY SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2023·2022-11-16

    Canon Aplio Ultrasound Systems Software Defect May Misassign Patient Images

    Canon Aplio ultrasound systems may fail to properly terminate the Stress Echo protocol, potentially causing patient images to be assigned to wrong patients or not saved. This could delay diagnosis and treatment.

    Product
    Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450
    Category
    Medical Device
    Distribution
    23 states
  • 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-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-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-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
  • 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
  • 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-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-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-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-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
  • 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
  • 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 H
    Category
    Medical Device
    Distribution
    Distributed nationwide