FDAHealthFebruary 16, 2026
ConvaTec, Inc — Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
⚠️ 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:423653 10-35mm
- Brand
- ConvaTec, Inc
- Lot code
- 5K01728
Additional details
UDI: 00768455221363 Lot: 5K01728
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
Get Health recall alerts
Delivered to your inbox. Free. No account required.