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BIGFOOT BIOMEDICAL, INC.

Last updated September 17, 2026

Information

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Device	Model / Reference	Registries	Class	Status
Bigfoot Unity Diabetes Management System	FG-300173	FDA UDI	Class II	Active
Bigfoot Unity	FG-301192	FDA UDI	Class II	Active
Bigfoot Unity Diabetes Management System	FG-300175	FDA UDI	Class II	Active
Bigfoot Unity Diabetes Management System	FG-300176	FDA UDI	Class II	Active
Bigfoot Unity Diabetes Management System	FG-300206	FDA UDI	Class II	Active
Bigfoot Unity Diabetes Management System	FG-300192	FDA UDI	Class II	Active
Bigfoot Unity Diabetes Management System	ASM-10060	FDA UDI	Class II	Active
Bigfoot Unity Diabetes Management System	FG-300200	FDA UDI	Class II	Active
Bigfoot Unity	FG-301190	FDA UDI	Class II	Active
Bigfoot Unity	FG-301185	FDA UDI	Class II	Active
Bigfoot Unity Report	SW-300983	FDA UDI	Class I	Active
Bigfoot Unity Diabetes Management System	K202145	FDA 510(k)FDA UDI	Class II	Active
Bigfoot Unity® Diabetes Management System	K222280	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 21, 2025	Z-1997-2025	—	open, classified	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.