FDA-Device2026-03-25Class II

Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm

ConvaTec, Inc
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:423653 10-35mm

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1583-2026

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