The Recall Desk

Hazard

Software Update recalls

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

What the numbers show

Total
35
Critical
27
Severe
1
Most recent
2025-10-22

Of the 35 software update recalls we have scored against our rubric, 27 (77%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) 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 update 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.

26–35 of 35

  • CriticalFDA (Devices)·Z-0095-2026·2025-10-22

    Pacemakers recalled for software update preventing Safety Mode from battery impedance

    Boston Scientific is recalling 223,163 ESSENTIO DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L111, ESSENTIO DR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0083-2026·2025-10-22

    ACCOLADE dual chamber extended life pacemakers recalled for software update

    Boston Scientific is recalling 7,488 ACCOLADE DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    ACCOLADE DR EL (Model L321)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2127-2025·2025-07-23

    Medtronic SmartSync software update removes an erroneous electrical reset message

    Medtronic SmartLink Software on the SmartSync Patient Connector is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 3,909 units affected.

    Product
    Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2128-2025·2025-07-23

    Medtronic CareLink SmartSync software update removes an erroneous reset message

    Medtronic SmartLink software on the CareLink SmartSync Device Manager is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 5,418 units affected.

    Product
    Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3.…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateNHTSA·24V051000·2024-01-30

    Tesla brake warning light font size fails federal display standard

    Tesla is recalling certain 2012-2024 vehicles because the Brake, Park and ABS warning lights display at an incorrect font size, failing FMVSS 105 and 135. A free over-the-air update fixes it.

    Product
    TESLA — TESLA MODEL S, MODEL X, MODEL 3, MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0978-2018·2018-03-21

    Philips HeartStart XL+ Defibrillator Software Update Recall

    Philips is recalling 4,315 HeartStart XL+ defibrillators in China to update software that improves device readiness information.

    Product
    HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2051-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Software and Hardware Update Recall

    St. Jude Medical is updating software and hardware for HeartMate II LVAS devices to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1040-2017·2017-01-25

    Beckman Coulter AutoMate 2500 Family Recalled for Operating System Update

    Beckman Coulter is recalling four AutoMate 2500 Family units in Maryland to update the PC image for Windows 10 compatibility.

    Product
    AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1024-2013·2013-04-10

    Zyno Medical Recalls Z-800 Volumetric Infusion Systems for Software Update

    Zyno Medical LLC is recalling 2,589 Z-800 Volumetric Infusion Systems to update the Preventative Maintenance schedule and add software to monitor fluid volume.

    Product
    Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0950-2013·2013-03-20

    Philips Brilliance 64 and Ingenuity CT Systems Software Update Recall

    Philips Medical Systems is recalling 42 Brilliance 64 and Ingenuity CT systems to update software and customer release notes.

    Product
    Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different…
    Category
    Medical Device
    Distribution
    19 states