ConvaTec EsteemBody Drainable Pouches
Convatec EsteemBody Drainable Pouch may leak due to a manufacturing issue.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
ConvaTec, Inc. of Greensboro, North Carolina, began a recall on February 16, 2026, for EsteemBody Drainable Pouches because the drainable large pouch may leak due to a manufacturing issue. The recall was added to the FDA's Enforcement Report on March 19, 2026.
The pouches were distributed nationwide in the US and worldwide in countries including Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, and the UK.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your pouch affected?
3 products
Match the UDI-DI and lot code listed under your product.
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
- UDI-DI
- 00768455221264
- Lot
- 5K00011
- 5K00714
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
- UDI-DI
- 00768455221363
- Lot
- 5K01728
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
- UDI-DI
- 00768455221400
- Lot
- 5J03908
Details
- Company began the recall
- Sold in
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.
- Event ID
- 98455
- Recall numbers
- Z-1582-2026 to Z-1584-2026
- Company
- ConvaTec, IncGreensboro, North Carolina
- Hazard
- Manufacturing deviation
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
