BIGFOOT BIOMEDICAL: Medical Device Recalls in 2025

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by BIGFOOT BIOMEDICAL in 2025. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

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.