Hazard

Firmware Error recalls

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

What the numbers show

Total: 12
Critical: 0
Severe: 0
Most recent: 2025-07-02

Of the 12 firmware error 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.

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 firmware 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.

1–12 of 12

HighFDA (Devices)·Z-1997-2025·2025-07-02
Bigfoot Unity Diabetes Management System Pen Caps Unresponsive Due to Firmware Error
Bigfoot Biomedical is recalling Bigfoot Unity Diabetes Management System Pen Caps due to a firmware issue that may cause insulin pens to become unresponsive. People with diabetes may lack information needed to make timely treatment decisions.
Product
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·25V368000·2025-06-11
Nova Bus turn signal indicator lights may remain solidly illuminated
Nova Bus is recalling certain 2022-2023 LFS buses because a digital display firmware error may leave the instrument panel turn signal indicators solidly lit, failing FMVSS 108.
Product
NOVA BUS — NOVA BUS LFS
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1686-2025·2025-05-07
IceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings
Boston Scientific is recalling 435 IceSeed 1.5 CX S cryoablation needles manufactured between April 2024 and February 2025 that were programmed with DEMO settings instead of Commercial settings, which can cause the Cryoablation System to prompt repeated tests if the needle is disconnected and reconnected.
Product
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0463-2022·2022-01-12
Abbott Alinity m System camera firmware installation issue
Abbott Molecular is recalling 74 Alinity m Systems due to an issue with the installation of updated camera firmware. Affected devices were distributed in the United States and internationally.
Product
Alinity m System, Part No. 08N53-002
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0031-2022·2021-10-13
Sleep Recording Device with Firmware Error Affecting Position Detection
Nox T3s Recorder sleep monitoring devices are being recalled due to a firmware error that causes inaccurate detection of device position, which may affect diagnostic accuracy.
Product
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2199-2020·2020-06-10
Inpeco Accelerator a3600 Automation System Recalled for Sample Dilution Risk
Inpeco is recalling 97 Accelerator a3600 Automation Systems because a firmware error may dilute primary samples with distilled water during clot detection.
Product
Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1085-2019·2019-04-10
Advanced Bionics Recalls Naída CI Q90 Sound Processor Due to Firmware Error
Advanced Bionics is recalling one Naída CI Q90 Sound Processor because it was loaded with incorrect firmware. The device was distributed in North Carolina and several foreign countries.
Product
Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0078-2018·2017-11-15
Boston Scientific Recalls 12 Resonate EL ICD Devices for Firmware Error
Boston Scientific is recalling 12 Resonate EL ICD DR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.
Product
RESONATE EL ICD DR, Model D433, Sterile.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0081-2018·2017-11-15
Boston Scientific Recalls 11 Resonate X4 CRT-D Devices for Firmware Error
Boston Scientific is recalling 11 Resonate X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.
Product
RESONATE X4 CRT-D, Model G447, Sterile.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0077-2018·2017-11-15
Boston Scientific Recalls Five Resonate EL ICD VR Devices for Firmware Error
Boston Scientific is recalling five Resonate EL ICD VR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.
Product
RESONATE EL ICD VR, Model D432, Sterile.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0079-2018·2017-11-15
Boston Scientific Recalls Four VIGILANT X4 CRT-D Devices for Firmware Error
Boston Scientific is recalling four VIGILANT X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.
Product
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1)
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0080-2018·2017-11-15
Boston Scientific Recalls Four Momentum X4 CRT-D Devices for Firmware Error
Boston Scientific is recalling four Momentum X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.
Product
MOMENTUM X4 CRT-D, Model G138, Sterile.
Category
Medical Device
Distribution
2 states