Product Wiki · Recalls · U.S. FDA — Device Enforcement

Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm — recall Z-1582-2026

U.S. FDA — Device Enforcement · United States · 2026-02-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1582-2026
Date of alert
2026-02-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ConvaTec, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00768455221264
Reported risk: Drainable large pouch may leak due to manufacturing issue.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.