FDA-Device2026-03-25Class IIPROCESSING DEFECT
ConvaTec EsteemBody Drainable Pouch recalled for potential leakage due to manufacturing defect
What this means
ConvaTec has recalled certain EsteemBody Drainable Pouches (REF: 423657, 10-35mm) because they may leak due to a manufacturing issue. The affected pouches have lot number 5J03908. No injuries have been reported.
- Stop using the affected pouch if you have lot number 5J03908
- Check your pouch packaging for the lot number
- Contact ConvaTec for a replacement pouch
- Call your healthcare provider if you have questions
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:423657 10-35mm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1584-2026Want us to check the next one for you?
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