FDA-Device2026-03-25Class IIPROCESSING DEFECT
ConvaTec EsteemBody Drainable Pouch recalled for potential leakage due to manufacturing defect
What this means
ConvaTec's EsteemBody Drainable Pouch (model REF:423643, 10–45mm) may leak because of a manufacturing issue. The affected pouches have lot numbers 5K00011 or 5K00714 and have been distributed worldwide. No injuries have been reported.
- Check your pouch for lot number 5K00011 or 5K00714 on the packaging.
- Stop using the pouch if it matches the recalled lot numbers.
- Contact ConvaTec or your healthcare provider for a replacement or instructions.
- Report any leakage or injuries to the FDA at SafetyReporting.HHS.gov.
The agency's original wording
Hazard
Drainable large pouch may leak due to manufacturing issue.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
N/A
Manufactured in
7815 National Service Rd Ste 600, N/A, Greensboro, NC, United States
Products
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1582-2026Want us to check the next one for you?
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