FDA recall, , Moderate risk
Esteem Body Soft Convex Urostomy Pouch
Esteem Body Soft Convex Urostomy Pouch may leak from cap during use.
Summary by Recall Canary from the FDA notice
What happened
ConvaTec, Inc., of Greensboro, North Carolina, recalled its Esteem Body Soft Convex Urostomy Pouch because the pouches may leak from the cap during use. The recall began on July 6, 2026, and was added to the FDA's Enforcement Report on August 19, 2026, with the agency classifying it on the same date.
The product was distributed nationwide, including in Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and the District of Columbia.
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?
Affected if its model number and UDI-DI are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Esteem Body Soft Convex Urostomy Pouch
- Model number
- 423703
- 423704
- 423705
- 423707
- 423708
- 423709
- 423710
- 423712
- 423713
- 423714
- 423715
- 423716
- 423717
- 423718
- 423721
- 423722
- 423723
- 423725
- 423726
- 423727
- UDI-DI
- 00768455204526
- 00768455204533
- 00768455204540
- 00768455204564
- 00768455204571
- 00768455204588
- 00768455204595
- 00768455204618
- 00768455204625
- 00768455204632
- 00768455204649
- 00768455204656
- 00768455204663
- 00768455204670
- 00768455204700
- 00768455204717
- 00768455204724
- 00768455204748
- 00768455204755
- 00768455204762
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington.
- Company
- ConvaTec, IncGreensboro, North Carolina
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99457
- Recall number
- Z-2986-2026
- Quantity recalled
- 617850 units
All recalls from ConvaTec, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
