ConvaTec Esteem+ Durahesive Plus — Class II medical device recall Z-0128-2023
Ongoing recall by ConvaTec, Inc, reported 2022-11-02, distributed nationwide. impaired functionality of the release liner
| Recall number | Z-0128-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2022-08-16 |
| Classified | 2022-10-24 |
| Reported by FDA | 2022-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 182 units |
| UPC / GTIN / UDI-DI | 00768455115334 |
| Lot numbers | 2A02671 |
| Model numbers | 416975 |
Product
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.
Reason for recall
impaired functionality of the release liner
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-0128-2023. 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.