Device recall
Z-0487-2025: MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated…
FDA device recall · Class II · ETHICON, INC.
Key facts
| Recall number (Z-number) | Z-0487-2025 |
|---|---|
| Recall event | 95583 |
| Product | MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery. |
| Product code | GAN |
| Recalling firm | ETHICON, INC. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K964072 |
| FEI number | 3006638824 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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