Device recall
Z-1396-2022: YelloPort Elite Universal Seal. For use in laparoscopic procedures.
FDA device recall · Class II · Surgical Innovations Ltd
Key facts
| Recall number (Z-number) | Z-1396-2022 |
|---|---|
| Recall event | 90447 |
| Product | YelloPort Elite Universal Seal. For use in laparoscopic procedures. |
| Product code | GCJ |
| Recalling firm | Surgical Innovations Ltd |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K190592 |
| FEI number | 3002808173 |
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