The Recall Desk

Hazard

Unapproved Software recalls

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

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2025-08-06

Of the 7 unapproved software recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 unapproved software 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.

1–7 of 7

  • ModerateFDA (Devices)·Z-2219-2025·2025-08-06

    ASPIRE Cristalle mammography systems shipped with unapproved slabbing software enabled

    ASPIRE Cristalle Mammography Systems with the Digital Breast Tomosynthesis option are being recalled because devices had an unapproved slabbing software function enabled for use. 293 units affected.

    Product
    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0549-2022·2022-02-09

    Philips eCareManager versions recalled due to unapproved Sentry Score software

    Philips is recalling certain versions of eCareManager software because the Sentry Score feature was not approved by FDA prior to distribution. Users should contact Philips for updated information.

    Product
    eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2020·2020-03-25

    Boston Scientific DYNAGEN EL ICD DR Recall for Unapproved Software

    Boston Scientific is recalling one DYNAGEN EL ICD DR device because a software update downloaded unapproved applications to four programmers.

    Product
    Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of lif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1511-2020·2020-03-25

    Boston Scientific LATITUDE Programming System Software Update Recall

    Boston Scientific is recalling four LATITUDE Programming System devices that downloaded unapproved software applications.

    Product
    Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all commu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0238-2020·2019-11-06

    Mindray Rosebud Vital Signs Monitor Recalled for Unapproved Software Features

    Mindray is recalling 9 Rosebud Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2016·2016-07-27

    WalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes

    WalkMed Infusion is voluntarily recalling Triton and Triton FP infusion pumps due to unapproved changes to software, specifications, and intended use.

    Product
    The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2220-2016·2016-07-27

    WalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes

    WalkMed Infusion is recalling Triton and Triton FP infusion pumps due to unapproved changes to software, specifications, and intended use.

    Product
    The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide