BIGFOOT BIOMEDICAL
BIGFOOT BIOMEDICAL appears in FDA public data with 1 recall, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1997-2025, Class II) was initiated on May 21, 2025. Its most recent 510(k) clearance was granted on March 1, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1997-2025 | Class II | Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 | May 21, 2025 |