Device recall
Z-1096-2025: PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE…
FDA device recall · Class II · Ethicon, LLC
Key facts
| Recall number (Z-number) | Z-1096-2025 |
|---|---|
| Recall event | 96127 |
| Product | PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. |
| Product code | GAW |
| Recalling firm | Ethicon, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K133356 |
| FEI number | 2648650 |
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