FDA Device recall Z-1582-2026
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
- FDA Device
- Class II
- ongoing
- Published 2026-03-25
On 2026-03-25 the FDA classified a Class II recall of Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm by Convatec, citing drainable large pouch may leak due to manufacturing issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1582-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-16 |
| Published | 2026-03-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Convatec |
| Distribution | US |
Product
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Reason
Drainable large pouch may leak due to manufacturing issue.
Identifiers
| code_info | UDI: 00768455221264 Lot: 5K00011,5K00714 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1582-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.