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.

26–50 of 1332

  • ModerateFDA (Devices)·Z-1956-2026·2026-05-06

    Philips Ingenia 1.5T MRI System Stiffness Value Calculation Error Recall

    Philips Ingenia 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings due to image reconstruction parameter combinations. The error affects 54 units distributed worldwide.

    Product
    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V228000·2026-04-09

    Thomas Built Buses Recalls Saf-T-Liner C2 School Buses for Software Defect

    Daimler Trucks North America is recalling 2024-2027 Thomas Built Buses Saf-T-Liner C2 school buses because a software defect may prevent warning lights and the stop sign arm from activating.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2026·2026-04-08

    Vue Motion V12 may display cine image frames out of sequence

    Philips is recalling Vue Motion V12 because mis-ordered frames during dynamic cine runs may cause image frames to display out of sequence.

    Product
    Vue Motion V12. Product Number: 1017979.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2026·2026-04-08

    RefleXion X1 may deliver radiotherapy dose to the incorrect location

    RefleXion Medical is recalling the X1 Radiotherapy System because a software defect can mean angular roll corrections are not carried through to treatment delivery.

    Product
    RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1658-2026·2026-04-08

    BD Kiestra ReadA modules may be unreachable after a system reboot

    BD is recalling the Kiestra ReadA because after a system reboot one or more modules may become unreachable via the remote connectivity interface, delaying plate retrieval.

    Product
    BD Kiestra" ReadA; Catalog No.: 446948.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1635-2026·2026-04-01

    Medtronic MiniMed 780G software defects may cause insulin delivery inaccuracies

    Medtronic is recalling MiniMed 780G insulin pumps on software 6.60 and 6.61 because three software defects could result in hypoglycemia or hyperglycemia through inaccurate insulin delivery.

    Product
    MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2026·2026-03-18

    Beckman Coulter AU5800 analyzer may stop analyzing after database errors

    Beckman Coulter is recalling Chemistry Analyzer AU5800 units because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.

    Product
    CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2026·2026-03-18

    Beckman Coulter DxC 700 AU analyzer may stop analyzing after errors

    Beckman Coulter is recalling DxC 700 AU analyzers because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.

    Product
    DxC 700 AU, REF: B86444, B86446
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2026·2026-03-11

    Roche cobas analyzer may repeat previous results for spline calibrated assays

    Roche is recalling cobas pro sample supply units on software versions before 03-02 because a defect can make the analyzer repeat the last calculated result for all later measurements.

    Product
    cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1475-2026·2026-03-11

    GE radiology viewer may show patient information not matching displayed images

    GE Healthcare is recalling Centricity Universal Viewer Zero Footprint Client because under certain workflows the patient information shown may not match the images displayed.

    Product
    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25E084000·2025-12-08

    Waymo Recalls 5th Generation Automated Driving Systems for School Bus Safety

    Waymo is recalling 3,067 5th Generation Automated Driving Systems because software may cause vehicles to pass stopped school buses, increasing crash risk.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0594-2026·2025-12-03

    Diabetes clinic software recalled over incorrect sensor glucose graph data

    Medtronic MiniMed is recalling 12,126 CareLink Clinic installations because a software error displays incorrect data on the 24-hour sensor glucose overview graph.

    Product
    CareLink Clinic, REF: MMT-7350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2026·2025-11-26

    Oncology software recalled because appended medication orders may mismatch the schedule

    Elekta is recalling four systems running MOSAIQ Oncology Information System builds 3.1.3 through 3.2.3.0 because appended wave medication orders may not match the intended schedule.

    Product
    MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2026·2025-11-19

    Hematology analyzers recalled because saturation flags may not be applied

    Abbott Laboratories is recalling 833 Alinity hq Analyzers because a software issue means the system does not visibly flag results when saturation is present, which may give incorrect results.

    Product
    Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E077000·2025-11-18

    Volvo Trucks Recalls Bendix EC80 Electronic Control Units for Software Defect

    Volvo Trucks is recalling certain Bendix EC80 Advanced Electronic Control Units due to a software defect that may cause safety systems to fail, increasing crash risk.

    Product
    SERVICE BRAKES, AIR:ANTILOCK:CONTROL UNIT/MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V788000·2025-11-14

    Bronco models recalled because the instrument cluster may fail at startup

    Ford is recalling 229,609 model year 2025-2026 Bronco and Bronco Sport vehicles because the instrument panel cluster may fail at startup, hiding warning lights and vehicle speed.

    Product
    FORD — FORD BRONCO SPORT, BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V785000·2025-11-13

    Accord Hybrids recalled because a control module reset can cut drive power

    Honda is recalling 256,603 model year 2023-2025 Accord Hybrid vehicles because a software error may reset the integrated control module CPU while driving, causing a loss of drive power.

    Product
    HONDA — HONDA ACCORD HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0427-2026·2025-11-12

    Insulin pumps recalled over false vibration motor failure stopping delivery

    Tandem Diabetes Care is recalling 17,745 Tandem Mobi insulin pumps because a software issue can trigger a false vibration motor failure that halts insulin delivery. The FDA classified it Class I.

    Product
    Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set,
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0416-2026·2025-11-12

    Cardiology records system recalled over data saved to the wrong patient

    Spacelabs Healthcare is recalling 142 Sentinel V11 cardiology information systems because patient demographics may default to a previous patient and test data may be saved under another patient's record.

    Product
    Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0318-2026·2025-11-05

    Glucose monitoring app recalled because it can terminate and miss alerts

    Dexcom is recalling version 1.15.0 of the G6 and G6 Pro Android CGM app because a software defect can terminate the app, stopping glucose values, alarms and alerts. The FDA classified it Class I.

    Product
    Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0409-2026·2025-11-05

    Dialysis connectivity software recalled because prescription changes may not reach cyclers

    Vantive is recalling the Sharesource Connectivity Platform for Homechoice Claria because a software defect may stop updated prescription settings from saving on the patient's cycler.

    Product
    Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2026·2025-11-05

    CT scanners recalled over six software faults affecting movement and dose

    Philips Medical Systems is recalling 105 Incisive CT scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

    Product
    Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0377-2026·2025-11-05

    Brazil market CT scanner recalled over six software faults affecting movement

    Philips Medical Systems is recalling one Incisive CT for Brazil SKD unit on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

    Product
    Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states