Z-1584-2026 Class II Ongoing

Recalled by ConvaTec, Inc — Greensboro, NC

Recall Details

Product Type
Devices
Report Date
March 25, 2026
Initiation Date
February 16, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm

Reason for Recall

Drainable large pouch may leak due to manufacturing issue.

Distribution Pattern

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.

Code Information

UDI: 00768455221400/ Lot: 5J03908