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BIGFOOT BIOMEDICAL Recalls

1 recall on record · July 2, 2025 to July 2, 2025 · Medical Devices

July 2, 2025Medical DevicesFDA

BIGFOOT BIOMEDICAL recalls Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuratio

Hazard: 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.

BIGFOOT BIOMEDICAL Recalls | RecallWatchUSA