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.

101–125 of 1332

  • 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
  • HighFDA (Devices)·Z-1991-2025·2025-06-25

    ICU Medical Plum Solos Infusion Pump Software Safety Defect Recall

    ICU Medical is recalling Plum Solos infusion pumps (Item 400011001) with software version 1.1.1 due to a workflow that may bypass the Maximum Dose Limit alert, which is designed to prevent overdose. The defect affects 214 units distributed across nine US states and the Philippines.

    Product
    ICU Medical Plum Solos, Item number 400011001; infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1868-2025·2025-06-18

    Z-800WF Infusion System software verification defect recall

    Zyno Medical LLC is recalling 613 units of the Z-800WF Infusion System because unreleased software versions were installed on distributed devices without verification or validation.

    Product
    Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2025·2025-06-18

    iBOT PMD Personal Mobility Device Software Update Recall

    Mobius Mobility LLC is recalling 442 units of the iBOT PMD (Personal Mobility Device) with software version 01.05.24 due to a software issue that could cause the device to tip over during Balance Mode operation.

    Product
    iBOT PMD with software version 01.05.24. Personal Mobility Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V403000·2025-06-13

    Lincoln Navigator side marker and daytime running lights may fail

    Ford is recalling certain 2022 Lincoln Navigator vehicles previously repaired under recall 22V455 because headlight control module software may fail the side marker and daytime running lights.

    Product
    LINCOLN — LINCOLN NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V324000·2025-06-04

    2025 Nissan Frontier rear display may blank in reverse

    The 2025 Nissan Frontier's center information display may show a blank screen in reverse, violating federal rear-visibility standards. This could reduce driver visibility and increase crash risk.

    Product
    NISSAN — NISSAN FRONTIER, KICKS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V369000·2025-06-02

    2023 Mitsubishi Outlander: Rearview Camera Software Defect Recall

    Mitsubishi is recalling 198,940 certain 2022-2024 Outlander and 2023-2025 Outlander PHEV vehicles due to a software error that may freeze or prevent the rearview camera from displaying, reducing rear visibility and increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, OUTLANDER PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1803-2025·2025-05-28

    Philips Ingenia Elition X MRI System Alignment Error Recall

    Philips has recalled specific Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25E037000·2025-05-22

    Zoox Recalls Driverless Vehicles for Software Defect in Person Detection

    Zoox is recalling Automated Driving Systems with older software that may fail to detect people next to the vehicle, increasing injury risk.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1763-2025·2025-05-21

    LifeShield Infusion Safety Software Recalled for Drug Library Defects

    ICU Medical is recalling LifeShield Drug Library Management software v2.1 and v2.2 due to defects that could allow over-delivery of medication to patients or unauthorized modification of drug parameters.

    Product
    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25E034000·2025-05-12

    Waymo Recalls 5th Generation Automated Driving Systems for Collision Risk

    Waymo is recalling 5th Generation Automated Driving Systems with older software that may cause vehicles to collide with roadway barriers like chains and gates.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V315000·2025-05-09

    Ford recalls over a million vehicles for rearview camera software error

    Ford is recalling a wide range of 2021-2025 vehicles because a software error may cause the rearview camera image to freeze or go missing. 1,076,138 units are affected.

    Product
    FORD — FORD, LINCOLN TRANSIT, EDGE, ESCAPE, F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V297000·2025-05-08

    Ram 2500 and 3500 gear selection displays may be inaccurate

    Chrysler is recalling certain Ram 2500 and 3500 vehicles with a 3.5 inch cluster and column shifter because a software error may make the gear selection display inaccurate.

    Product
    RAM — RAM 2500, 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V282000·2025-05-08

    Volvo rearview camera image may not display when reversing

    Volvo is recalling certain 2021-2025 vehicles because the rearview camera image may not display when the vehicle is placed in reverse. 413,151 units are affected.

    Product
    VOLVO — VOLVO EC40, V90CC, C40BEV, V60CC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1703-2025·2025-05-07

    myQA iON dosimetry device analysis result miscalculation issue

    IBA Dosimetry GmbH is recalling the myQA iON dosimetry device (Article Number MQ10-000) because creating two structures with identical names except for a special character causes wrong analysis results.

    Product
    myQA iON; Article Number: MQ10-000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2025·2025-04-30

    BD PYXIS MEDBANK Automated Dispensing Cabinet Software Defect

    CareFusion's BD PYXIS MEDBANK and MEDFLEX automated dispensing cabinets may experience a software issue during bin restocking that doubles bin quantities, potentially delaying access to medications and supplies.

    Product
    BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2025·2025-04-30

    Abbott CELL-DYN Ruby hematology analyzer affected by expired reagent date masking

    Abbott is recalling the CELL-DYN Ruby hematology analyzer because expired reagents may have their expiration dates automatically changed to current or future dates without user notification, potentially leading to use of expired reagents.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2025·2025-04-30

    CELL-DYN Ruby hematology analyzer expiration date software defect

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because a software defect allows expired reagents to be used without user notification. The system may incorrectly update expiration dates to current or future dates, contrary to the operator's manual.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2025·2025-04-30

    CELL-DYN Ruby Hematology Analyzer Expiration Date Software Defect

    Abbott's CELL-DYN Ruby hematology analyzer may accept expired reagents without alerting the operator, potentially allowing use of expired materials in patient testing.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2025·2025-04-30

    CELL-DYN Ruby hematology analyzer medical device recall

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because expired reagents may be used without user notification when scanned or manually entered into the system, contrary to manufacturer guidelines.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E029000·2025-04-25

    Zoox Recalls Robotaxis Due to Software Crash Risk

    Zoox is recalling 2024 robotaxis because a software defect may cause the vehicle to fail to avoid a crash when another vehicle stops perpendicularly.

    Product
    ZOOX — ZOOX ZOOX ROBOTAXI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1520-2025·2025-04-23

    Tandem Mobi Insulin Pump Software Defect Risks Incorrect Insulin Delivery

    Tandem Diabetes Care is recalling Tandem Mobi Insulin Pumps with software version 7.9 due to a defect that can cause incorrect insulin delivery when glucose data gaps occur, potentially leading to severe high or low blood sugar.

    Product
    Tandem Mobi Insulin Pump with Interoperable Technology
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-1519-2025·2025-04-23

    t:slim X2 Insulin Pump Software Defect Affecting Glucose Delivery

    Tandem Diabetes Care is recalling 63 units of the t:slim X2 Insulin Pump with software version 7.9 due to a defect that can cause incorrect insulin delivery. The defect may lead to dangerous blood sugar levels when glucose monitoring loses connection.

    Product
    t:slim X2 Insulin Pump with Interoperable Technology
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-1543-2025·2025-04-16

    Stimulation RC Clinician Programmer Application Software Communication Issue

    The Stimulation RC Clinician Programmer Application (Model A71400) has a software issue that can permanently disable communication with certain implantable neurostimulators when a specific intraoperative programming sequence is used. Approximately 1,493 devices were distributed worldwide.

    Product
    Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
    Category
    Medical Device
    Distribution
    Distributed nationwide