Device recall
Z-1997-2025: Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap…
FDA device recall · Class II · BIGFOOT BIOMEDICAL
Key facts
| Recall number (Z-number) | Z-1997-2025 |
|---|---|
| Recall event | 96925 |
| 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… |
| Product code | QLG |
| Recalling firm | BIGFOOT BIOMEDICAL |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K202145 |
| FEI number | 3016525500 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database