Convatec Esteem — Class II medical device recall Z-1890-2018
Terminated recall by ConvaTec, Inc, reported 2018-05-23, distributed nationwide. It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is lar
| Recall number | Z-1890-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2018-04-25 |
| Classified | 2018-05-16 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2023-02-27 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 7F00987 |
| Model numbers | 405475 |
Product
Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.
Reason for recall
It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.
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-1890-2018. 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.