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.

101–125 of 1375

  • HighFDA (Devices)·Z-0216-2026·2025-10-29

    Immunoassay analyzers recalled over dilution factor anomaly affecting patient results

    Beckman Coulter is recalling 571 DxI 9000 Access Immunoassay Analyzers over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Part Number C11137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2026·2025-10-29

    Central monitoring stations recalled over reboot loop at specific network sizes

    GE HealthCare is recalling 2,306 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 5867474-03; Medical Display, cathode ray tube
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0145-2026·2025-10-22

    Shoulder surgical planning software recalled over possible implant malalignment risk

    Kico Knee Innovation Company is recalling 21 ARVIS Shoulder systems after a complaint identified an issue with the AI surgical planning software that may cause implant malalignment.

    Product
    Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2026·2025-10-22

    LOGIQ P10 HD systems recalled over inaccurate liver steatosis measurement values

    GE is recalling 31 LOGIQ P10 R4.5 HD ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.

    Product
    LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2026·2025-10-22

    LOGIQ P9 ultrasound systems recalled over inaccurate liver steatosis measurements

    GE is recalling 37 LOGIQ P9 R4.5 ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.

    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-0132-2026·2025-10-22

    Omnipod 5 app recalled because magnifying a field duplicates typed digits

    Insulet is recalling 174,013 units of the Omnipod 5 iOS app because using the iPhone magnifier on a manual entry field while typing can duplicate a digit.

    Product
    The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2026·2025-10-22

    Ultrasound systems recalled over inaccurate liver steatosis measurement values

    GE is recalling 65 LOGIQ P10 series systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.

    Product
    LOGIQ P10 series with software version R4.5.7 Model Number 5877534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2026·2025-10-15

    Angiography systems recalled over collimator returning to default region of interest

    Canon Medical Systems is recalling eight radiography/fluoroscopy systems because changing the acquisition program returns the collimator to a default ROI, leaving the X-ray area partially covered by a static image.

    Product
    This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·25V689000·2025-10-10

    Ford Mustangs recalled again over brake fluid warning light that fails

    Ford is recalling 2,101 Mustangs that were repaired incorrectly under an earlier recall, because the brake fluid level sensor may not activate the low-fluid warning indicator.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2673-2025·2025-10-08

    Ophthalmic imaging software recalled over measured areas smaller than actual values

    MedicalCommunications GmbH is recalling 474 units of HEYEX 2 / HEYEX PACS software because a measured value may be smaller than the actual area.

    Product
    Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0030-2026·2025-10-08

    Radiology software recalled because reports may not display fully when viewed

    Change Healthcare is recalling 12 programs running Radiology Solutions software version 14.2.2 because a software issue means radiology reports may not be fully displayed.

    Product
    Change Healthcare Radiology Solutions software version 14.2.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2638-2025·2025-10-08

    Vein ablation generators recalled over software falsely flagging working catheters

    BD is recalling 1,725 Venclose digiRF generators running software 3.35 because the catheter verification check produces false positive failures on properly functioning catheters.

    Product
    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0032-2026·2025-10-08

    Clinical chemistry analyzer modules recalled over stalled test status and delays

    Beckman Coulter is recalling 116 DxC 500 AU modules because a clinical chemistry sample can remain In Progress with no error when an immunoassay test is processed between chemistry tests.

    Product
    DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·25V670000·2025-10-07

    2022-2025 Lucid Air Recalled for Rearview Camera Software Defect

    Lucid is recalling 2022-2025 Air vehicles due to a software defect that may prevent the rearview camera from displaying or show inaccurate images, increasing crash risk. A free over-the-air software update will be provided.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V665000·2025-10-06

    2025 RAM PROMASTER Battery Electric Vehicles Loss of Drive Power

    Chrysler is recalling certain 2024–2025 RAM ProMaster battery electric vehicles due to software issues in the electric drive module that may cause loss of drive power, increasing crash risk.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2621-2025·2025-10-01

    Insulin pump app recalled over defect in right-to-left language settings

    The t:slim X2 Insulin Pump with the Tandem t:slim mobile app is recalled because an app defect in right-to-left language settings causes pairing and graphical faults that could lead to incorrect therapy decisions.

    Product
    t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·25V657000·2025-10-01

    Toyota Tundra and Sequoia Hybrid rear visibility software defect recall

    Toyota is recalling 2022-2025 Tundra, Tundra Hybrid, and 2023-2025 Sequoia Hybrid vehicles due to a software error that may prevent the rearview image from displaying when in reverse, reducing driver visibility and increasing crash risk.

    Product
    TOYOTA — TOYOTA TUNDRA HYBRID, TUNDRA, SEQUOIA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2570-2025·2025-09-24

    Radiation planning software recalled over image errors in three patient orientations

    Pinnacle Radiation Therapy Planning System software is recalled because of a potential image error of the Region of Interest for expansion or contraction in head first prone, feet first supine and feet first prone orientations.

    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2569-2025·2025-09-24

    Laboratory information software recalled over data removed from first form field

    MEDITECH Expanse Laboratory modules are recalled because entering multiple keys that trigger input simultaneously may remove data from the first field of screens or questionnaires. 148 units are affected.

    Product
    MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2543-2025·2025-09-17

    Cardiovascular software recalled because it may display outdated information

    IntelliSpace Cardiovascular software version 8.0.0.4 is recalled because of a software issue that results in the display of outdated information. 4 units are affected.

    Product
    IntelliSpace Cardiovascular, Software 8.0.0.4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V594000·2025-09-11

    Electric pickups recalled because stability control warning light may not illuminate

    GM is recalling certain 2026 Chevrolet Silverado EV and GMC Sierra EV vehicles because the ESC malfunction warning light may not illuminate after a fault, failing to comply with FMVSS 126. 1,191 units are affected.

    Product
    GMC — GMC, CHEVROLET SIERRA EV, SILVERADO EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V595000·2025-09-11

    Toyota and Lexus vehicles recalled over instrument panel software display error

    Toyota is recalling a wide range of 2023-2025 Toyota and Lexus vehicles because an instrument panel software error at startup can leave the display without critical information. 591,377 units are affected.

    Product
    TOYOTA — TOYOTA, LEXUS redundant VENZA, HIGHLANDER, VENZA HYBRID, CAMRY HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2448-2025·2025-09-10

    Dexcom G7 watchOS app recalled because sensor failure alerts are missing

    The Dexcom G7 CGM watchOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS…
    Category
    Medical Device
    Distribution
    Distributed nationwide