← FDA ENFORCEMENT
Z-1584-2026Class II
ConvaTec, Inc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
ConvaTec, Inc
Product type
Device
Status
Ongoing
Report date
2026-03-25
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.
Firm state
NC
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
Drainable large pouch may leak due to manufacturing issue.
Product description
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Code / lot info
UDI: 00768455221400/ Lot: 5J03908
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See all Risk Management & CAPA recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →