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.

326–350 of 1375

  • ModerateFDA (Devices)·Z-1664-2023·2023-06-07

    VITROS Chemistry Calibrator Kit Cannot Calibrate Vancomycin Reagent

    Ortho-Clinical Diagnostics is recalling 132 units of VITROS Chemistry Calibrator Kit 11 with defective Assay Data Disk versions due to inability to calibrate vancomycin reagent, delaying laboratory testing.

    Product
    VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2023·2023-05-24

    Beckman Coulter Urine Analyzer Software Flag Display Issue Affects Carryover Detection

    Beckman Coulter is recalling 107 DxU 850m Iris Urine Microscopy Analyzers worldwide due to an intermittent software issue where a quality-control flag is enabled but not displayed, potentially preventing detection of sample carryover contamination.

    Product
    DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1579-2023·2023-05-17

    BD Pyxis MedStation ES software failure causes patient data loss

    BD Pyxis automated dispensing cabinet software versions 1.7.0 through 1.7.4 experience download failures causing partial loss of patient information and transaction data. This may result in dispensing incorrect medication doses, allergenic medications, or discontinued medications.

    Product
    BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V309000·2023-05-02

    Mercedes-Benz Recalls 2022-2023 EQS and EQE Models for Battery Software Defect

    Mercedes-Benz is recalling 3,828 vehicles because high-voltage battery monitoring software may fail to alert drivers of malfunctions, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQS450, S 580 E, EQS580, EQS 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1394-2023·2023-04-26

    Radiometer AQURE Software Recall Due to Patient Mix-up Risk

    Radiometer is recalling AQURE laboratory software versions 2.5.2 through 2.6.1 due to a potential issue that could cause patient data mix-ups.

    Product
    AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1353-2023·2023-04-19

    PET/CT Imaging System Recall: Software Issue Prevents Image Reconstruction

    Shanghai United Imaging uMI 550 PET/CT imaging system is recalled due to a software defect that may prevent scatter correction during patient scanning, potentially blocking diagnostic PET image generation.

    Product
    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V265000·2023-04-13

    2021 RAM 1500 Recalled for Engine Stall Risk from Software Defect

    Chrysler is recalling 2021 RAM 1500 trucks (5.7L eTorque) for an engine stall issue caused by powertrain control software. Engine stall can increase crash risk; dealers will update the software free of charge.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1307-2023·2023-04-05

    ACL ELITE PRO analyzer test definition removal for Anti-Xa reagent

    Instrumentation Laboratory is removing test definitions for HemosIL Liquid Anti-Xa reagent from ACL Elite and Elite Pro analyzers with Serial Number 16053360R and prior. The recall affects 33 units distributed worldwide.

    Product
    ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2023·2023-03-29

    BD Pyxis Automated Medication Dispensing Systems Firmware Downgrade Recall

    CareFusion recalls 7,914 units of BD Pyxis automated medication dispensing systems after firmware was inadvertently downgraded during installation, potentially causing drawer failures and medication delivery delays.

    Product
    BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2023·2023-03-29

    Wearable ECG smartwatch software bug eliminates physician review

    Withings Scan Monitor/ScanWatch (model hwa09) has a software defect preventing physicians from reviewing ECG recordings, which is critical to the device's FDA clearance requirement for physician-supervised use. Users should discontinue use until the defect is corrected.

    Product
    Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V156000·2023-03-23

    Spartan Fire Recalls 2022-2024 Firetrucks Due to Transmission Software Defect

    Spartan Fire is recalling 2022-2024 Gladiator, Metro Star, FC-94, and KME Panther firetrucks because the transmission may fail to engage the water pump after reversing.

    Product
    SPARTAN FIRE — SPARTAN FIRE, KME FC-94, redundant PANTHER, GLADIATOR, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2023·2023-03-08

    Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules

    Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.

    Product
    MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V120000·2023-02-23

    2022–2024 International and IC Bus Trucks/Buses: Engine Control Software Defect

    Navistar is recalling 2022-2024 International HV and MV trucks and 2022-2023 IC Bus TC buses. An engine control module software defect can cause the engine to override the parking brake when the transmission remains in drive or reverse and the power take-off switch is engaged, resulting in unintended vehicle movement.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS MV, TC, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V119000·2023-02-23

    International commercial trucks recalled for park brake software defect

    Navistar is recalling 2018-2022 International trucks with a software defect that may prevent the park brake from holding during power-take-off operation, risking unexpected vehicle movement.

    Product
    INTERNATIONAL — INTERNATIONAL MV, HV, RH, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0961-2023·2023-02-01

    Getinge Flow-e Anesthesia System Software Defect Prevents Patient Ventilation

    Getinge Flow-e Anesthesia System units with certain software versions contain a bug that can prevent pressure buildup and ventilation delivery. This may result in inadequate oxygen delivery and hypoxia in anesthesia patients.

    Product
    Getinge Flow-e Anesthesia System, Part No. 6887900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0959-2023·2023-02-01

    Getinge Flow-i Anesthesia Systems Recalled for Software Ventilation Defect

    Getinge Flow-i Anesthesia Systems models C20, C30, and C40 are being recalled due to a software bug that can prevent proper ventilation, potentially leading to hypoxia in patients.

    Product
    Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2023·2023-02-01

    Invisalign Orthodontic Aligners Recalled for Software Defect Causing Incorrect Quantities

    Align Technology is recalling Invisalign Express 10, Comprehensive, and Moderate systems due to a software defect that may produce incorrect numbers of aligners and incorrect packaging.

    Product
    Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V040000·2023-02-01

    2021 Volkswagen ID.4 Software Defect May Cause Loss of Drive Power

    Volkswagen is recalling 2021 ID.4 vehicles because a software defect in the battery management system may cause loss of drive power, increasing the risk of a crash. Free software updates will be provided by dealers.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1004-2023·2023-02-01

    Agfa HealthCare XERO Viewer Medical Imaging Software Class II Defect

    Agfa Healthcare has recalled XERO Viewer imaging software due to a software defect that can cause issues with images. The defect affects approximately 110 units distributed across the US and 19 other countries.

    Product
    Agfa HealthCare Enterprise Imaging XERO Viewer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0952-2023·2023-01-18

    Medical device software bug may cause patient sample order mismatches in rare cases

    A software bug in Roche Diagnostics' cobas infinity central lab may cause orders to be mismatched to wrong patient samples under rare circumstances. The issue affects 224 US units and 2,797 devices worldwide.

    Product
    cobas infinity central lab, Material Number 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V007000·2023-01-16

    Peterbilt 579 and Kenworth T680 electronic stability control software defect

    PACCAR is recalling approximately 46 Peterbilt 579 (2022-2023) and Kenworth T680 (2023) vehicles with faulty electronic stability control software that may underestimate vehicle mass, reducing crash prevention performance. Dealers will provide a free software update.

    Product
    KENWORTH — KENWORTH, PETERBILT T680, 579
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2023·2022-12-28

    Medical Imaging Software Update May Hide Patient Studies

    After installing the IAS tool, Centricity PACS-IW Universal Viewer version 5.0 may hide some medical imaging studies without notification. Accessing hidden studies requires GE Healthcare assistance and may cause diagnostic delays.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0268-2023·2022-11-30

    Diagnostic System Software Defects Affecting Sample Processing and Test Accuracy

    Abbott is recalling 883 Alinity m diagnostic systems due to software defects affecting sample identification, system operation, and test calibration. The issues affect all serial numbers running software version 1.6.5.

    Product
    Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V853000·2022-11-18

    Midwest Fire Recalls 2021-2022 All-Poly Series Fire Trucks

    Midwest Fire is recalling 2021-2022 All-Poly Series fire trucks because a software defect may prevent shifting between road and pump modes, potentially delaying emergency response.

    Product
    MIDWEST FIRE — MIDWEST FIRE ALL-POLY SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2023·2022-11-16

    Canon Aplio Ultrasound Systems Software Defect May Misassign Patient Images

    Canon Aplio ultrasound systems may fail to properly terminate the Stress Echo protocol, potentially causing patient images to be assigned to wrong patients or not saved. This could delay diagnosis and treatment.

    Product
    Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450
    Category
    Medical Device
    Distribution
    23 states