Convatec — Class II medical device recall Z-1583-2026
Ongoing recall by ConvaTec, Inc, reported 2026-03-25, distributed nationwide. Drainable large pouch may leak due to manufacturing issue.
| Recall number | Z-1583-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2026-02-16 |
| Classified | 2026-03-19 |
| Reported by FDA | 2026-03-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CN, CZ, DE, DK, FI, GB, IE, IT, JP, NL, NO, PL, SE, SK |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00768455221363 |
| Lot numbers | 5K01728 |
| Model numbers | 10-35MM, 423653 |
Product
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Reason for recall
Drainable large pouch may leak due to manufacturing issue.
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-1583-2026. 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.