FDAHealthFebruary 16, 2026
ConvaTec, Inc — Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
⚠️ Drainable large pouch may leak due to manufacturing issue.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 16, 2026
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.
What's affected?
- Product
- Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
- Brand
- ConvaTec, Inc
- Lot code
- 5K00011
Additional details
UDI: 00768455221264 Lot: 5K00011,5K00714
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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