FDA-Device2026-03-25Class IIPROCESSING DEFECT
ConvaTec EsteemBody Drainable Pouch recalled for potential leakage due to manufacturing defect
OTHERNationwide distribution
Stop using ConvaTec EsteemBody Drainable Pouch
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.
Hazard
Drainable large pouch may leak due to manufacturing issue.
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-1582-2026More ConvaTec, Inc recalls
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief