ConvaTec EsteemBody Drainable Pouch Recall - Manufacturing Defect Causes Leaking
Summary
FDA announces Class II recall of ConvaTec EsteemBody Drainable Pouch (REF:423657, 10-35mm) due to manufacturing defect causing potential leaks. The recall affects worldwide distribution including US nationwide and multiple countries including Australia, Canada, Germany, Italy, and others. Affected parties should verify product and contact ConvaTec for replacement.
What changed
FDA initiated a Class II recall for ConvaTec EsteemBody Drainable Pouch (REF:423657, 10-35mm) due to a manufacturing issue that may cause the drainable large pouch to leak. The recall is ongoing and affects worldwide distribution.
Healthcare providers and patients using this ostomy product should verify whether they have affected units and contact ConvaTec for replacement or further guidance. distributors should coordinate with ConvaTec to manage the recall of this medical device.
What to do next
- Verify product against recall list
- Stop using affected devices
- Contact ConvaTec for replacement
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
ConvaTec, Inc
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1584-2026 · 20260325 · Ongoing
Product
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Reason for Recall
Drainable large pouch may leak due to manufacturing issue.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Ja...
Source: openFDA Enforcement API
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