Recall Z-1583-2026— ConvaTec, Inc

Name: FDA recall Z-1583-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-16

Class II · Ongoing

Class II FDA medical device recall by ConvaTec, Inc, initiated 2026-02-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm. Reason: Drainable large pouch may leak due to manufacturing issue..

Recalling firm: ConvaTec, Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-02-16
Firm location: Greensboro, NC, United States

Product description

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

Reason for recall

Drainable large pouch may leak due to manufacturing issue.

Data sourced from openFDA. This site is unofficial and independent of the FDA.