ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm

Recall date

February 16, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1582-2026

FDA classification

Class II

Brand / firm

ConvaTec, Inc

Sold / distributed

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.

Why it was recalled

Drainable large pouch may leak due to manufacturing issue.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm