ConvaTec EsteemBody drainable pouch recalled for possible leaks
ConvaTec has recalled certain EsteemBody Drainable Pouches (model REF:423653, 10-35mm) because they may leak due to a manufacturing issue. The affected product has lot number 5K01728. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Stop using the recalled pouch if you have lot number 5K01728
- Contact ConvaTec for a replacement or refund
- If you have questions, check the product box for contact information or visit ConvaTec's website
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 7815 National Service Rd Ste 600, N/A, Greensboro, NC, United States
- Classification
- Class II
- Recall number
- Z-1583-2026
In the FDA's words
- Description
- Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm Drainable large pouch may leak due to manufacturing issue. UDI: 00768455221363 Lot: 5K01728 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. Affected quantity: N/A
- Hazard
- Drainable large pouch may leak due to manufacturing issue.
3 products in this recall
The agency lists each product separately. Check every one you might have.
- Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mmZ-1582-2026 · N/A
- Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm (this page)Z-1583-2026 · N/A
- Convatec, EsteemBody Drainable Pouch REF:423657 10-35mmZ-1584-2026 · N/A
More from ConvaTec
- ConvaTec Esteem Body urostomy pouches recalled for possible cap leaks
ModerateFDAAug 26, 2026