The Recall Desk

Hazard

Software Defect recalls

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

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 316

  • HighFDA (Devices)·Z-2038-2025·2025-07-09

    VITROS 5600 Integrated System Software Anomaly Causes Erroneous Test Results

    A software anomaly in the VITROS 5600 causes the system to incorrectly treat unexpired reagent packs as expired, potentially producing erroneous test results. The manufacturer is recalling affected units.

    Product
    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V508000·2025-07-08

    2025 Nissan Frontier daytime running lights may dim unexpectedly

    Nissan is recalling certain 2025 Frontier vehicles due to a software error that can cause daytime running lights to dim unexpectedly when the engine restarts. This may confuse other drivers and increase crash risk.

    Product
    NISSAN — 2025 NISSAN FRONTIER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2025·2025-07-02

    Medical device software defect affecting laboratory result validation and reference ranges

    REMISOL Advance laboratory data management system has a software bug that incorrectly identifies patients as newborns when date of birth is empty or set to 01/01/1900, potentially affecting result validation and reference range calculations.

    Product
    REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2025·2025-06-18

    Philips Azurion X-ray imaging systems affected by software communication defect

    A software communication issue in Philips Azurion X-ray imaging systems can cause loss of imaging functionality during use, potentially delaying critical treatment for emergency patients.

    Product
    Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: Al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2025·2025-06-18

    Personal Mobility Device Software Issue May Cause Tipping

    Mobius Mobility's iBOT personal mobility device may tip over due to a software issue affecting balance mode. The FDA recalls 442 units distributed across multiple states.

    Product
    iBOT PMD with software version 01.05.24. Personal Mobility Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2025·2025-06-18

    Guardian System 2 Controller software update addresses missing battery alerts

    Turncare is issuing a software update to the Guardian System 2 Controller to correct a bug where low and terminal battery alerts did not display under certain conditions.

    Product
    Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V665000·2025-06-10

    2024-2025 RAM ProMaster Loss of Drive Power Software Defect

    Chrysler is recalling 2024-2025 RAM ProMaster electric vehicles due to a software defect in the electric drive module that can cause loss of drive power and increase crash risk. No injuries have been reported.

    Product
    RAM — 2025 RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V065000·2025-06-02

    2025 Hyundai IONIQ 5 N Braking Software Defect Recall

    Hyundai is recalling certain 2025 IONIQ 5 N vehicles with left-foot braking feature due to software defect that may reduce braking performance. Affected owners should stop using the LFB feature until the software update is applied.

    Product
    HYUNDAI — 2025 HYUNDAI IONIQ 5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2025·2025-05-28

    Philips SmartPath MRI device recalled for potential alignment errors

    Philips is recalling SmartPath to dStream 1.5T MRI systems for potential alignment errors in the MobiView image review application. 80 units affected worldwide.

    Product
    Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1797-2025·2025-05-28

    Ingenia 3.0T MRI System Software Defect Affecting Image Alignment

    Philips Ingenia 3.0T MRI systems may display misaligned cross reference lines in the MobiView image review application, potentially affecting diagnostic accuracy. Firmware updates are required for affected units.

    Product
    Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1789-2025·2025-05-28

    Medical imaging device alignment error in cross-reference functionality

    Philips SmartPath to dStream medical imaging devices may display alignment errors in cross-reference lines when reviewing images with the MobiView application, potentially affecting diagnostic accuracy.

    Product
    Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1792-2025·2025-05-28

    Philips MR 7700 upgrade recalled for image alignment errors

    Philips recalls upgrade to MR 7700 system due to potential alignment errors in MobiView cross-reference line functionality when reviewing images. No injuries or illnesses reported.

    Product
    Product Name: Upgrade to MR 7700; Model Number: 782130;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2025·2025-04-30

    Abbott CELL-DYN Ruby Hematology Analyzer Recall for Expired Reagent Handling Defect

    Abbott is recalling CELL-DYN Ruby hematology analyzers that silently accept expired reagents without user notification, potentially allowing inaccurate laboratory test results.

    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
  • HighFDA (Devices)·Z-1652-2025·2025-04-30

    Medical analyzer software permits expired reagent use without notification

    Abbott's CELL-DYN Ruby analyzer has a software defect allowing expired reagents to be used without notification. The system incorrectly changes expiration dates to current or future dates.

    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-1655-2025·2025-04-30

    Abbott CELL-DYN Ruby analyzer silently accepts expired reagents

    Abbott's CELL-DYN Ruby analyzer has a software defect where expired reagents cause it to change their expiration dates without alerting operators, risking inaccurate test results.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 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

    Medical device software malfunction may use expired reagents

    Abbott's CELL-DYN Ruby hematology analyzer contains a software flaw that masks expired reagent warnings, potentially allowing use of expired reagents in patient testing.

    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-1639-2025·2025-04-30

    Automated Dispensing Cabinet Software Bug Causes Double Inventory Quantities

    BD PYXIS automated dispensing cabinets have a software bug that can double bin quantities during restocking, potentially delaying medication access.

    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
  • SevereFDA (Devices)·Z-1519-2025·2025-04-23

    t:slim X2 and Mobi Insulin Pump Software Defect Affecting Glucose Readings

    Tandem Diabetes Care is recalling t:slim X2 and Mobi insulin pumps with software version 7.9 due to a defect that miscalculates glucose trends during sensor connection gaps, potentially causing incorrect insulin dosing.

    Product
    t:slim X2 Insulin Pump with Interoperable Technology
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-1520-2025·2025-04-23

    Tandem Mobi Insulin Pump Software Defect Can Cause Incorrect Insulin Dosing

    Tandem Mobi and t:slim X2 insulin pumps with Version 7.9 software may deliver incorrect insulin doses due to a glucose-reading defect, risking dangerous high or low blood sugar levels.

    Product
    Tandem Mobi Insulin Pump with Interoperable Technology
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1550-2025·2025-04-16

    Software defect in automated medication dispensing cabinet prevents restocking

    A software defect in BD Pyxis MedBank dispensing cabinets prevents medication restocking, potentially delaying patient access. Affected cabinets display an error message blocking the restocking process.

    Product
    BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXI
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1543-2025·2025-04-16

    Medtronic neurostimulator programmer software issue disables implant communication

    The Stimulation RC Clinician Programmer Application (Model A71400) has a software issue that can permanently disable communication with implanted neurostimulators when a specific intraoperative programming sequence is used.

    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
  • HighFDA (Devices)·Z-1517-2025·2025-04-09

    Clinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation

    Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to a software defect that prevents calculated test results from being recalculated when constituent tests are rerun, potentially delaying patient result reporting.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V324000·2025-04-06

    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 — 2025 NISSAN FRONTIER
    Category
    Vehicle
    Distribution
    Distributed nationwide