The Recall Desk

Hazard

Software Error recalls

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

What the numbers show

Total
487
Critical
2
Severe
30
Most recent
2026-10-14

Of the 487 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 30 (6%) 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.

1–25 of 487

  • ModerateFDA (Devices)·Z-0084-2027·2026-10-14

    Beckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error

    Beckman Coulter is recalling DxC 500 AU Clinical Chemistry Analyzers due to a software issue that may cause test units to revert to defaults without warning, potentially resulting in falsely elevated reported results.

    Product
    DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3155-2026·2026-10-07

    Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk

    Philips is recalling Spectral CT 7500 software due to a tracking crash that may cause patients to receive additional radiation.

    Product
    Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3275-2026·2026-10-07

    Bard EnCor EnCompass Breast Biopsy System Software Recall

    Bard Peripheral Vascular Inc is recalling 99 EnCor EnCompass Breast Biopsy and Tissue Removal Systems due to software errors that may interrupt procedures.

    Product
    EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3332-2026·2026-10-07

    Beckman Coulter AU480 Chemistry Analyzer Software Error Recall

    Beckman Coulter is recalling AU480 Chemistry Analyzers because a software error prevents the instrument from starting, delaying patient results.

    Product
    Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3249-2026·2026-09-30

    Philips EPIQ Elite Ultrasound System Recalled for Software Error

    Philips is recalling 219 EPIQ Elite Diagnostic Ultrasound Systems due to a software issue that may cause inaccurate blood flow velocity measurements and potential misdiagnosis.

    Product
    Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2834-2026·2026-08-12

    REMISOL Advance Software Version 2.5 Recalled for Incorrect Test Result Reporting

    Beckman Coulter Biomedical GmbH is recalling REMISOL Advance Software Version 2.5 because it may incorrectly report combo assay test outcomes.

    Product
    REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2842-2026·2026-08-12

    Quantum Outback Powered Wheelchair Controller Recalled Due to Unexpected Braking Risk

    Pride Mobility Products Corp. is recalling Quantum Outback powered wheelchairs due to a software issue that may cause unexpected braking and potential injury.

    Product
    Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2844-2026·2026-08-12

    Quantum Rehab R-TRAK Powered Wheelchair Controller Recalled Due to Software Issue

    Pride Mobility Products Corp. is recalling Quantum Rehab R-TRAK powered wheelchairs due to a software issue that can cause unexpected braking or system crashes.

    Product
    Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2861-2026·2026-08-12

    DASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results

    Nuclein LLC is recalling the DASH Rapid PCR Instrument (Model SG-0002) because a software issue may result in false co-infection readings.

    Product
    Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2849-2026·2026-08-12

    Quantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking

    Pride Mobility Products Corp. is recalling the Quantum Rehab Q6 Edge 3 powered wheelchair controller due to a software issue that can cause unexpected braking and potential injury.

    Product
    Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2026·2026-07-29

    Boston Scientific TheraSphere 360 Y-90 Management Platform Software Recall Due to Calculation Error

    Boston Scientific Corporation is recalling the TheraSphere 360 Y-90 Management Platform (Model M00139509001) due to a software anomaly that may cause incorrect dose calculations.

    Product
    Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2793-2026·2026-07-29

    SafeOp Patient Interface Neuromonitoring Device Recalled Due to Software Issue

    Alphatec Spine, Inc. is recalling the SafeOp Patient Interface due to a software issue that may cause loss of electromyography functionality during surgery.

    Product
    SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2777-2026·2026-07-29

    Emano Flow Uroflowmetry App Recalled Over Biased Flow Estimates

    Emano Metrics is recalling 685 units of the Emano Flow smartphone-based acoustic uroflowmetry app (v2.0.0) because recordings captured at 48,000 Hz were processed by models trained on 44,100 Hz audio, producing systematically biased urinary flow rate and voided volume estimates.

    Product
    Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2675-2026·2026-07-29

    BOSS Xe Family Aiming Devices Recalled for Software Safety Enhancement

    Wilcox Industries Corp. is recalling BOSS Xe family aiming devices to implement a software enhancement designed to increase safety.

    Product
    The intended use is to be paired with a weapon for aiming purposes.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2554-2026·2026-07-01

    Thuvera Laser Console Software Version 2.2 Recall Notice

    IPG Medical Corporation is recalling the Thuvera Laser Console (Software Version 2.2) due to a software anomaly that causes false display of error code 5018. The defect affects 198 units distributed nationwide in Massachusetts.

    Product
    Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2360-2026·2026-06-24

    Automated Impella Controller software error affects left ventricular support devices

    Automated Impella Controllers are being recalled because of a potential software error when used with left ventricular Impella devices. 10,297 units are affected.

    Product
    Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V400000·2026-06-23

    Hyundai Tucson instrument panel displays may fail due to software error

    Hyundai is recalling certain 2025-2026 Tucson, Tucson Hybrid and Tucson Plug-In Hybrid vehicles because a software error may cause the instrument panel display to fail.

    Product
    HYUNDAI — HYUNDAI TUCSON, TUCSON HYBRID, TUCSON PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V321000·2026-05-20

    Volkswagen Tiguan rearview camera may fail to display after repair

    Volkswagen is recalling certain 2024 Tiguan vehicles previously repaired under recall 25V082 because a camera control unit error at startup can stop the rearview image displaying.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1947-2026·2026-05-06

    AIDBAG First Aid Kits with Recalled Blood Glucose Meters Recalled

    North American Rescue LLC. is recalling AIDBAG first aid kits containing McKesson TRUE Metrix PRO blood glucose meters that display an E-5 error code incorrectly, potentially delaying appropriate patient treatment.

    Product
    AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1962-2026·2026-05-06

    Philips Ingenia Elition S MRI stiffness value error correction

    Philips Ingenia Elition S MRI systems with MR Elastography may display incorrect voxel size settings in the default scan protocol when certain image reconstruction parameters are used, potentially leading to stiffness value errors.

    Product
    Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1966-2026·2026-05-06

    Philips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall

    Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.

    Product
    Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1828-2026·2026-04-29

    CUSA Clarity C7000 Ultrasonic Surgical Aspirator Touch Screen Unresponsiveness

    Integra LifeSciences is recalling the CUSA Clarity C7000 Console (Software Version 2.1.1.909) due to a software issue that renders the touch screen unresponsive during surgical use.

    Product
    CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V262000·2026-04-23

    Jeep Wagoneer S and Dodge Charger instrument panel displays may fail

    Chrysler is recalling certain Jeep Wagoneer S and Dodge Charger electric vehicles because a software error may cause the instrument panel display to fail, breaching five federal standards.

    Product
    JEEP — JEEP, DODGE WAGONEER S, CHARGER EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V227000·2026-04-09

    Honda Odyssey side air bags may deploy unexpectedly from software error

    Honda is recalling certain 2018-2022 Odyssey vehicles because a software programming error can cause the side and side curtain air bags to deploy unexpectedly. 440,830 vehicles are affected.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide