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.

76–100 of 1375

  • 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-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.…
    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…
    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…
    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…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • HighFDA (Devices)·Z-0376-2026·2025-11-05

    CT 5300 scanners recalled over six software faults affecting movement and dose

    Philips Medical Systems is recalling 165 CT 5300 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: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0412-2026·2025-11-05

    Sample preparation systems recalled over incorrect dead volumes in instructions

    Beckman Coulter is recalling 108 CellMek SPS sample preparation systems because the instructions for use list incorrect dead volumes and the software does not rock Cassette E.

    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-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
  • HighNHTSA·25V744000·2025-10-30

    Toyota, Lexus, and Subaru vehicles with defective panoramic rearview camera

    Toyota Motor Engineering & Manufacturing is recalling 2022–2026 Toyota, Lexus, and Subaru vehicles with a Panoramic View Monitor system due to a software error that may freeze or blank the rearview camera in reverse, reducing rear visibility and increasing crash risk.

    Product
    LEXUS — LEXUS, TOYOTA, SUBARU LS HYBRID, BZ4X, VENZA HYBRID, ES HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0213-2026·2025-10-29

    Central stations recalled over reboot loop that halts patient monitoring

    GE HealthCare is recalling 173 Carescape Central Stations running software V3.0.5 because the system can enter a continuous reboot cycle, losing central monitoring of connected patients.

    Product
    GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0215-2026·2025-10-29

    Clinical analyzer modules recalled over dilution factor software anomaly affecting results

    Beckman Coulter is recalling 160 DxC 500i Clinical Analyzer modules over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.

    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

    Insulin pumps recalled over software defect causing unexpected correction bolus

    Tandem Diabetes Care is recalling 122,958 t:slim X2 and Mobi insulin pumps because a software defect when paired with a Dexcom G7 sensor may trigger an unexpected automatic correction bolus.

    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