Device recall
Z-3180-2026: EWO_02513 (Catalog number 320122) For Investigational Use Only Nano…
FDA device recall · Class II · embecta Medical II LLC
Key facts
| Recall number (Z-number) | Z-3180-2026 |
|---|---|
| Recall event | 99593 |
| Product | EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100 |
| Product code | FMI |
| Recalling firm | embecta Medical II LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K213478 |
| FEI number | 3022699058 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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