Company: Bigfoot Biomedical
Date of Enforcement Report: 6/20/2025
Class: II
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 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.
Recall Number:
Z-1997-2025
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.
RECALLING FIRM/MANUFACTURER:
Bigfoot Biomedical
VOLUME:
57 pen caps
DISTRIBUTION:
U.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX, and WA
