Class II

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

ConvaTec, Inc · February 16, 2026

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.

States Affected

NATIONWIDE

Quantity Affected

N/A

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1583-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.