The Recall Desk

Hazard

Software Error recalls

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

What the numbers show

Total
482
Critical
2
Severe
26
Most recent
2026-08-12

Of the 482 software error recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (5%) 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 error 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.

151–175 of 482

  • ModerateFDA (Devices)·Z-1144-2021·2021-03-03

    Siemens ARTIS Icono Biplane and Floor Systems Recalled for Software Errors

    Siemens is recalling 41 ARTIS Icono systems with software version VE20B due to misleading error messages and manual gaps that may cause procedure termination.

    Product
    ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0934-2021·2021-02-10

    Brainreader Recalls Neuroreader Software Due to Database Discrepancy

    Brainreader ApS is recalling Neuroreader Medical Image Processing Software Version 2.4 because it was distributed with a reference database different from the FDA-cleared version.

    Product
    Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0940-2021·2021-02-10

    Biomeme PCR Thermocycler Recalled Due to Software Error Preventing Test Completion

    Biomeme, Inc. is recalling 147 Franklin Real-Time PCR Thermocycler systems because a software error causes instrument failure, preventing users from completing 2019-nCoV tests.

    Product
    Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,10000
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0883-2021·2021-01-27

    Roche Cobas Infinity Software Error May Allow Unreliable Lab Results

    Roche is recalling 76 licenses of Cobas Infinity software due to an error that may remove quality flags, allowing unreliable test results to be reported.

    Product
    A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2021·2020-12-30

    Haag-Streit Surgical Floor Stands Recalled for Software Error

    Haag-Streit USA Inc. is recalling surgical floor stands and operating microscopes due to a software error that may cause focusing movement to continue after the footswitch is released.

    Product
    Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling 9,353 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0715-2021·2020-12-30

    Baxter Spectrum IQ Infusion System Recalled for Potential Software Error

    Baxter Healthcare is recalling Spectrum IQ Infusion Systems with Dose IQ Safety Software due to a potential software error during programming.

    Product
    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0714-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling 140,006 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0564-2021·2020-12-23

    FDA Recalls Tempus LS Manual Defibrillators Due to Software Error

    Remote Diagnostic Technologies is recalling 175 Tempus LS manual defibrillators because a software error may delay therapy by disrupting ECG calibration.

    Product
    Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V771000·2020-12-10

    Honda Recalls Accord and Insight Vehicles for Software Error

    Honda is recalling 2018-2020 Accord and 2019-2020 Insight vehicles because a software error may cause system malfunctions that increase crash risk.

    Product
    HONDA — HONDA INSIGHT, ACCORD, ACCORD HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0513-2021·2020-12-09

    Biomeme SARS-CoV-2 PCR Test Recalled for False Positive Results

    Biomeme is recalling 105 units of its SARS-CoV-2 Real-Time RT-PCR Test because the software made false positive calls due to assay issues.

    Product
    The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V751000·2020-12-03

    Land Rover Recalls 2020 Models for Speedometer Display Software Error

    Land Rover is recalling 2020 Discovery Sport and Range Rover Evoque vehicles because a software error may cause the speedometer to randomly switch units, potentially distracting drivers.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE, DISCOVERY SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2021·2020-11-04

    Pentax 9310HD Digital Video Capture Module Recalled for Software Error

    Pentax of America Inc is recalling 39 units of the 9310HD Digital Video Capture Module due to a software issue that may copy patient exam videos to the wrong record.

    Product
    9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2983-2020·2020-09-30

    Beckman Coulter Recalls DxA 5000 Automated Sample Handling Systems

    Beckman Coulter is recalling 32 DxA 5000 automated sample handling systems because the instructions for use may be confusing regarding the re-use of sample IDs, leading to undetected barcode re-use.

    Product
    DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents samp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2899-2020·2020-09-02

    RayCare Oncology Software Recalled for Offline Image Review Error

    RaySearch Laboratories AB is recalling RayCare oncology software due to an error message that may prevent users from accessing offline images during review tasks.

    Product
    RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2020·2020-07-15

    United Imaging Recalls uDR 596i Digital Medical X-Ray Imaging Systems

    Shanghai United Imaging Healthcare is recalling six uDR 596i digital medical X-ray systems due to software errors that may cause incorrect anatomical positioning or loss of image tags, leading to additional radiation exposure.

    Product
    uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2506-2020·2020-07-15

    Medtronic Patient Connector Recall for Temporary Feature Suspension

    Medtronic is recalling 1,025 Patient Connectors because a rare communication error may temporarily suspend device features. The issue is unlikely to cause clinical impact and features restore automatically.

    Product
    Patient Connector, Model Number 24967
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2406-2020·2020-07-01

    Mevion Proton Radiation Treatment System Recalled for Software Error

    Mevion Medical Systems is recalling eight MEVION S250i and S250 Proton Radiation Treatment Systems because a software error can cause couch correction moves to be partially lost.

    Product
    MEVION S250i, MEVION S250; Proton Radiation Treatment System
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2202-2020·2020-06-10

    Agfa DR 800 X-Ray System Recalled for Dose Calculation Error

    Agfa N.V. is recalling 13 DR 800 digital radiography systems because a software error may cause incorrect dose calculations during specific fluoroscopic exams.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2020·2020-06-10

    Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error

    Insulet is recalling 400 Omnipod DASH insulin systems because the Bolus Calculator may fail to subtract insulin on board correctly after two months of use.

    Product
    Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2140-2020·2020-06-03

    Inpeco FlexLab Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling 37 FlexLab Automation Systems due to a firmware communication error that can cause sample tubes to be incorrectly associated with carriers.

    Product
    FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical proces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2142-2020·2020-06-03

    Inpeco Aptio Automation System Recalled for Sample Association Error

    Inpeco S.A. is recalling 70 Aptio Automation Systems with specific interface modules due to a firmware communication error that can cause erroneous sample-tube associations.

    Product
    Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2020·2020-06-03

    Inpeco Accelerator a3600 Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling three Accelerator a3600 Automation Systems due to a firmware communication error that can cause incorrect sample-tube associations.

    Product
    Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analyt
    Category
    Medical Device
    Distribution
    Distributed nationwide