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.

76–100 of 487

  • ModerateFDA (Devices)·Z-1910-2024·2024-06-05

    Stryker Mako Surgical Robot Software Error Causes Treatment Delays

    Stryker's Mako surgical robots may experience software errors causing treatment delays when switching between surgical modes without proper system restart. This affects 334 units globally.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2024·2024-05-01

    ACUSON Redwood 1.0 ultrasound displays incorrect cardiac measurement values

    The ACUSON Redwood 1.0 Diagnostic Ultrasound System may display the last measured cardiac value instead of the minimum or maximum value as configured, potentially leading to misdiagnosis or improper patient management.

    Product
    ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2024·2024-05-01

    ACUSON Juniper ultrasound systems display incorrect cardiac measurements

    Siemens ACUSON Juniper ultrasound systems may display the wrong cardiac measurement value when configured to show minimum or maximum values, potentially leading to misdiagnosis.

    Product
    ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1001-2024·2024-02-28

    Baxter Exactamix Pro 1200 Software Error Causes Medication Over-delivery

    Baxter Healthcare is recalling the Baxter Exactamix Pro 1200 medication compounding device due to a software error that may cause ingredient over-delivery when using the 'Use Some Overfill' feature.

    Product
    Baxter Exactamix Pro 1200, REF EXM12DY
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-0708-2024·2024-01-17

    Robotic Drill Recall: Users Unable to Resolve Disconnection Errors

    Blue Belt Technologies is recalling 1,859 CORI REAL INTELLIGENCE Robotic Drills (models ROB10013 and ROB10013S) because users cannot resolve drill disconnection error messages. No illnesses or injuries have been reported.

    Product
    CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2024·2023-11-08

    RX Daytona Plus Clinical Chemistry Analyzer Rerun Settings Malfunction

    Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.

    Product
    RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V733000·2023-11-01

    Mercedes-Benz Recalls 2020 GLS 580 for Sunroof Software Error

    Mercedes-Benz is recalling 2020 GLS 580 vehicles because a software error may cause the sunroof to close unexpectedly, increasing the risk of injury.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLS 580 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2023·2023-10-04

    exoplan 3.1 Dental Software Filtering Error Affects Surgical Guide Planning

    Dental planning software exoplan 3.1 contains a filtering error that may display all surgical guide options instead of only supported ones, potentially causing patient injury.

    Product
    exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2023·2023-09-27

    Philips Tempus Pro Patient Monitor Software Error Impairs Critical Monitoring

    Certain Philips Tempus Pro Patient Monitors may display an error message when laryngoscopes are disconnected, requiring a 60-100 second restart that prevents vital sign monitoring and airway visualization during intubation. This may lead to treatment delays or hypoxia.

    Product
    Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
    Category
    Medical Device
    Distribution
    42 states
  • HighNHTSA·23V574000·2023-08-11

    Mercedes-Benz Recalls 2023 Models for Exit Warning System Software Error

    Mercedes-Benz is recalling 880 2023 vehicles because a software error may prevent the exit warning system from alerting occupants to approaching vehicles.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 350, AMG GT43, E 450, CLS 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2103-2023·2023-07-19

    Baxter SIGMA Spectrum Infusion Pump false upstream occlusion alarm correction

    Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.

    Product
    SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2023·2023-06-14

    Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results

    BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.

    Product
    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2023·2023-05-03

    Hamilton HAMILTON-C6 Ventilator Software Error Disables Patient Input Monitoring

    The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.

    Product
    HAMILTON-C6, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V062000·2023-02-09

    Spartan Motorhome Chassis Software Error Causes Loss of Drive Power and Visibility

    Shyft Group is recalling 2022–2024 Spartan motorhome chassis due to a software error that may cause loss of drive power or safety functions like headlights and wipers. Owners should contact Shyft Group at 1-800-237-7806 for a free software update.

    Product
    SPARTAN — SPARTAN K2, K3, K4, K1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2023·2023-01-18

    Medtronic Vanta/Seqenita LT Neurostimulation Programmer Software Anomalies Recalled

    Medtronic recalls the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies generating error messages that may affect device operation. The recall affects 22 units distributed worldwide.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0928-2023·2023-01-18

    BD Pyxis MedBank System may dispense wrong medication due to software error

    The BD Pyxis MedBank medication dispensing system has a software error that may cause the wrong medication to be loaded in a drawer compared to what the label shows, risking patient harm.

    Product
    BD Pyxis MedBank System - Product Label/labeling pending
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2022·2022-10-05

    Mobile X-Ray System Recalled for Software Calibration Error in Radiation Dose Meter

    Micro-X Rover mobile X-ray systems recalled due to a software calibration error that causes incorrect radiation dose readings. The malfunction may impede proper radiation exposure management decisions.

    Product
    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2022·2022-09-21

    SCENARIA View software error may require additional patient radiation exposure

    SCENARIA View imaging software errors prevent image reconstruction, which may require additional scans and expose patients to unnecessary radiation.

    Product
    SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2022·2022-09-21

    ZAP-X Radiosurgery System Software Issue May Cause Treatment Misalignment

    A software issue in the ZAP-X Radiosurgery System may cause incorrect treatment positioning in patients with large rotational deviations. The alignment algorithm could miscalculate treatment table offset values, potentially affecting treatment delivery.

    Product
    ZAP-X Radiosurgery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2022·2022-09-21

    Pinnacle3 Radiation Therapy Planning System dose-calculation software error

    Philips Pinnacle3 radiation therapy planning systems may export incorrect dose information when multiple beams are used with certain Edit Prescription settings. 169 systems are affected.

    Product
    Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1672-2022·2022-09-07

    Medical device software error affects toric IOL surgical planning accuracy

    A software defect in the Pentacam AXL Wave eye imaging device's IOL calculator may inaccurately reflect alignment axis and incision position for toric lens surgeries. This affects 21 systems distributed across the U.S.

    Product
    Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1674-2022·2022-09-07

    Pentacam HR Medical Device Software Error Impacts Surgical Planning

    A software error in the Pentacam HR eye imaging device causes inaccurate IOL calculator output for toric intraocular lens surgical planning. Nineteen systems are affected.

    Product
    Pentacam HR REF 70900. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • SevereNHTSA·22V662000·2022-09-01

    Honda CRF1100 Africa Twin Motorcycles Recalled for Engine Control Software Bug

    Honda is recalling 2020-2021 CRF1100 Africa Twin motorcycles due to an ECU software error that may cause engine stall or loss of drive power. Owners can get a free software update from dealers.

    Product
    HONDA — HONDA CRF1100 AFRICA TWIN
    Category
    Vehicle
    Distribution
    Distributed nationwide