Esteem Synergy Stomahesive Skin Barrier — Class II medical device recall Z-0903-2025
Ongoing recall by ConvaTec, Inc, reported 2025-01-22, distributed in IL, NY, OH. Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as st
| Recall number | Z-0903-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2024-11-29 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | IL, NY, OH |
| Quantity | 240 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00768455185399, 00768455185450 |
| Lot numbers | 405473/00768455185399/3J03813, 405479/00768455185450/3J03814 |
| Model numbers | 405473, 405479 |
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
Reason for recall
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0903-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.