ConvaTec EsteemBody Drainable Pouch Recall - Manufacturing Defect
Summary
FDA has issued a Class II recall for ConvaTec EsteemBody Drainable Pouch (REF:423653, 10-35mm) due to a manufacturing defect causing the drainable large pouch to leak. The recall affects products distributed nationwide in the US and internationally to multiple countries including Australia, Canada, China, Germany, Italy, and others. The recall is ongoing.
What changed
FDA has classified a recall for ConvaTec EsteemBody Drainable Pouch as Class II due to leaking caused by a manufacturing issue. The affected product is REF:423653, 10-35mm, distributed both domestically in the US and internationally.
Healthcare providers and patients using these drainable pouches should immediately check inventory for affected products and contact ConvaTec for guidance on return or replacement. The manufacturing defect poses a risk of device failure during normal use, requiring users to transition to alternative products until the issue is resolved.
What to do next
- Discontinue use of affected ConvaTec EsteemBody Drainable Pouch products
- Contact ConvaTec for return/replacement instructions
- Notify healthcare providers and patients using affected devices
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-1583-2026 · 20260325 · Ongoing
Product
Convatec, EsteemBody Drainable Pouch REF:423653 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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