Device recall
Z-0903-2025: Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a…
FDA device recall · Class II · ConvaTec, Inc
Key facts
| Recall number (Z-number) | Z-0903-2025 |
|---|---|
| Recall event | 95955 |
| Product | Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479 |
| Product code | EXE |
| Recalling firm | ConvaTec, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3011987967 |
At a glance
- None 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