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.

76–100 of 1332

  • 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
  • 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 c
    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 VENZA HYBRID, CAMRY HYBRID, HIGHLANDER, RX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2447-2025·2025-09-10

    Dexcom G7 iOS app recalled because sensor failure alerts do not appear

    The Dexcom G7 CGM iOS 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 iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
    Category
    Medical Device
    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 phone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2446-2025·2025-09-10

    Glucose monitor apps recalled because sensor failed alerts do not appear

    Dexcom G7 and ONE+ CGM apps are recalled because the app does not give the expected Sensor Failed alert, instead silently ending the session. The FDA classified the action as Class I. 532,821 units are affected.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2449-2025·2025-09-10

    Dexcom ONE+ Android app recalled over missing sensor failure alerts

    The Dexcom ONE+ Android CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 41,629 units are affected.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose Monit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2450-2025·2025-09-10

    Dexcom ONE+ iOS app recalled because sensor failed alerts do not appear

    The Dexcom ONE+ iOS CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 39,309 units are affected.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring Sys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2025·2025-09-10

    InPen app recalled over software errors affecting insulin dose reminders

    Medtronic is recalling the InPen App for iOS and Android because software design errors could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. 6,816 units are affected.

    Product
    InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2493-2025·2025-09-10

    RayStation 12A planning software recalled over duplicate DICOM instance identifier risk

    RayStation 12A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2488-2025·2025-09-10

    RayStation 8B and 9A software recalled over DICOM identifier uniqueness defect

    RayStation 8B, its service packs and 9A radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2490-2025·2025-09-10

    RayStation 10B planning software recalled over DICOM identifiers not guaranteed unique

    RayStation 10B and 10B Service Pack 1 radiation therapy treatment planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2491-2025·2025-09-10

    RayStation 11A planning software recalled over non-unique DICOM instance identifiers

    RayStation 11A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Softw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2025·2025-09-10

    RayStation 7 and 8A software recalled over DICOM instance identifier defect

    RayStation 7, 8A and 8A Service Pack 1 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning Sys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2489-2025·2025-09-10

    RayStation 9B and 10A software recalled over non-unique DICOM identifiers

    RayStation 9B, 9B SP1, 10A and 10A service pack radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2494-2025·2025-09-10

    RayStation 6 service packs recalled over DICOM identifier uniqueness defect

    RayStation 6 Service Packs 1, 2 and 3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2495-2025·2025-09-10

    RayStation 2023B and 2024A software recalled over non-unique DICOM identifiers

    RayStation 2023B, 2024A and 2024A SP3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Plannin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2492-2025·2025-09-10

    RayStation 11B software recalled over non-unique DICOM instance identifiers

    RayStation 11B and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Soft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V585000·2025-09-08

    2025 Rivian R1S and R1T Recalled Due to Software Defect

    Rivian is recalling certain 2025 R1S and R1T vehicles because the Hands-Free Highway Assist software may fail to detect lead vehicles, increasing crash risk. A free over-the-air software update is available.

    Product
    RIVIAN — RIVIAN R1S, R1T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2016-2025·2025-07-02

    Omnipod 5 iOS App software design issue causes insulin overdose risk

    Insulet Corporation is recalling the Omnipod 5 iOS App due to a software issue where decimal separators are not recognized in manual insulin entry, potentially causing insulin overdose and severe hypoglycemia.

    Product
    Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface t
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·25V409000·2025-07-02

    Polestar 2 May Lose Brake Function While Using One Pedal Drive

    Certain 2021 and 2024 Polestar 2 vehicles may lose brake function while coasting downhill and using One Pedal Drive mode. Polestar will provide a free over-the-air software update to fix the control module defect.

    Product
    POLESTAR — POLESTAR POLESTAR 2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2025·2025-07-02

    Philips Spectral CT Computed Tomography X-ray System Software

    Philips Spectral CT systems with affected software may experience unintended motion of the gantry or table that could lead to contact with operators or patients. Additional software issues may also affect CT performance.

    Product
    Spectral CT. Computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    19 states