FDA recall Z-1583-2026

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, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.

Key facts

Status

Ongoing

Initiation date

2026-02-16

Report date

2026-03-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greensboro, NC, United States

Primary source

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