Device recall
Z-1515-2025: PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
FDA device recall · Class II · Ethicon Endo Surgery, LLC
Key facts
| Recall number (Z-number) | Z-1515-2025 |
|---|---|
| Recall event | 96461 |
| Product | PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM |
| Product code | NEW |
| Recalling firm | Ethicon Endo Surgery, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K133356 |
| FEI number | 3005075853 |
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