FDA-Device2026-08-26Class IIPROCESSING DEFECT
ConvaTec Esteem Body Soft Convex Urostomy Pouch recalled for potential cap leak
What this means
ConvaTec's Esteem Body Soft Convex Urostomy Pouches may leak from the cap during normal use. This affects multiple model numbers distributed nationwide across the U.S. No injuries have been reported to date.
- Check if you have one of the affected model numbers (423703–423727).
- Review the lot/serial numbers listed in the full recall notice to confirm your product is affected.
- Contact ConvaTec or your healthcare provider for a replacement or guidance on safe use.
- Do not discard the product; follow instructions from ConvaTec on return or disposal.
The agency's original wording
Hazard
Urostomy Pouches may leak from cap during use.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution including in the states of AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.
Affected count
617850 units
Manufactured in
7815 National Service Rd Ste 600, Greensboro, NC, United States
Products
Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2986-2026Want us to check the next one for you?
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