Class II — ConvaTec, Inc
| Recalling firm | ConvaTec |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Drainable large pouch may leak due to manufacturing issue. |
| Product | Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm |
| Quantity | N/A |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK. |
| Initiated | 2026-02-16 |
| Classified | 2026-03-19 |
| Recall number | Z-1582-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ConvaTec, Inc (Z-1582-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98455/
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