BIGFOOT BIOMEDICAL: Device Recall

Recall #Z-1997-2025 · 05/21/2025

Class II: Risk

Recall Details

Recall Number: Z-1997-2025
Classification: Class II
Product Type: Device
Recalling Firm: BIGFOOT BIOMEDICAL
Status: Ongoing
Date Initiated: 05/21/2025
Location: Milpitas, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 57 pen caps

Reason for Recall

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.

Product Description

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 Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) are part of the Bigfoot Unity Diabetes Management System.

Distribution Pattern

U.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX, and WA.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.