The Recall Desk

Hazard

Software Fault recalls

93 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
93
Critical
0
Severe
15
Most recent
2026-07-30

Of the 93 software fault recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (16%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software fault 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 93

  • ModerateFDA (Devices)·Z-1202-2026·2026-02-04

    A.T.S. 3200TS tourniquets recalled over screens that may freeze

    Zimmer Surgical is recalling 51 A.T.S. 3200TS Tourniquet Systems because the user interface may freeze or become unresponsive to touch in certain non-English language settings.

    Product
    Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS Tourniquet Systems Co
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1110-2026·2026-01-28

    RayStation v2025 treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 17.0.0 and 17.0.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1108-2026·2026-01-28

    RayStation 2024A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 15.2.0 and 15.1.3 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1113-2026·2026-01-28

    Azurion imaging systems recalled over two software issues affecting imaging

    Philips is recalling 228 Azurion systems on software version R3.1 over two software issues that may result in loss of imaging, loss of motorized movement, incorrect image content or loss of data.

    Product
    Philips Azurion system; Software Version Number: R3.1;
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1109-2026·2026-01-28

    RayStation 2024B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 16.0.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0415-2026·2026-01-28

    RayStation 10B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 10.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Mini Gaceniga Authentic Cuban Loaf Cake Classic (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1103-2026·2026-01-28

    RayStation 11A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 11.0.0, 11.0.1, 11.0.3 and 11.0.4 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1106-2026·2026-01-28

    RayStation 2023B and 2024A recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 14.0.0, 15.0.0 and 15.1.3 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1157-2026·2026-01-28

    RayStation 10B SP1 recalled over radiation dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 10.1.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    SQ40S Blood Transfusion Filter
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1104-2026·2026-01-28

    RayStation 11B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 12.0.0, 12.1.0, 12.0.3, 12.0.4 and 12.3.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1105-2026·2026-01-28

    RayStation 12A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 13.0.0.1547, 13.1.0.144 and 13.1.1.89 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0414-2026·2026-01-28

    Infusion pumps recalled over hard limit messages blocking piggyback flush programming

    ICU Medical is recalling Plum Duo Precision IV Pumps because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    Mini Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1118-2026·2026-01-28

    Plum Duo infusion pumps recalled over blocked piggyback flush programming

    ICU Medical is recalling the Plum Duo Infusion Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2026·2026-01-28

    Plum Solo pumps recalled over hard limit messages blocking flush programming

    ICU Medical is recalling the Plum Solo Precision IV Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V038000·2026-01-23

    Toyota Tundra rearview camera image may not display when reversing

    Toyota is recalling certain 2024-2025 Tundra and Tundra Hybrid vehicles with a Panoramic View Monitor because the rearview camera image may not display when the vehicle is placed in reverse.

    Product
    TOYOTA — TOYOTA TUNDRA, TUNDRA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1078-2026·2026-01-21

    Oncology information system recalled over a potential for overtreatment

    Elekta is recalling a MOSAIQ Oncology Information System with Particle Therapy License because a specific sequence can result in a partial treatment being delivered twice.

    Product
    MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2026·2026-01-21

    Azurion interventional systems recalled over nine identified software issues

    Philips Medical Systems Nederland is recalling 990 Azurion R3.0 systems over nine identified software issues, including loss of X-ray after a pedal tap and continuous restart.

    Product
    Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2026·2026-01-21

    Patient positioning systems recalled over stereotactic radiosurgery tolerance errors

    C-RAD Positioning is recalling 189 Catalyst and Catalyst+ systems because the system may indicate a patient as correctly positioned at the isocenter when it is outside tolerance.

    Product
    Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1091-2026·2026-01-21

    Azurion systems recalled over six identified software issues

    Philips Medical Systems Nederland is recalling 10,466 Azurion systems on software versions R2.1.10 and R2.2.10 over six identified software issues including continuous restart.

    Product
    Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1043-2026·2026-01-21

    Neurostimulator clinician programmer app recalled over faults during device use

    Medtronic is recalling 7,123 units of the Vanta Clinician Programmer Application after complaints that it does not function as intended during use.

    Product
    A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V017000·2026-01-16

    Lucid Air rearview camera image may not display when reversing

    Lucid is recalling certain 2022-2026 Air vehicles with the AD02 package on software versions 2.8.0 through 2.8.16, because the rearview camera image may not display when the vehicle is in reverse.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2026·2026-01-14

    Medication dispensing servers recalled over delayed updates from enterprise systems

    CareFusion 303 is recalling 2,079 BD Pyxis ES Enterprise Server systems over a software issue that may result in equipment not receiving timely updates of patient or medication information.

    Product
    BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0999-2026·2026-01-14

    Radiography systems recalled because collimation may be incorrect between programs

    Siemens Medical Solutions is recalling LUMINOS Lotus Max and Luminos dRF Max systems because switching quickly between organ programs may result in incorrect collimation.

    Product
    LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1007-2026·2026-01-07

    Ultrasound systems recalled over unexpected reboots that damage the transducer

    Philips Ultrasound is recalling 1,721 EPIQ Ultrasound Systems used with the X5-1c transducer because the system may experience an unexpected automatic reboot, resulting in damage to the transducer.

    Product
    Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
    Category
    Medical Device
    Distribution
    Distributed nationwide