Milpitas, CA, United States
BIGFOOT BIOMEDICAL recalls
1 recall recorded since 2018, most recently on 21 May 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 May 2025
- Reason
- Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.
- Distribution
- U.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1997-2025
- 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 Th
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.