ConvaTec, Inc recalls Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703

Urostomy Pouches may leak from cap during use.

On July 20, 2026 Convatec issued a Urgent Medical Device Recall notification to affected consignees via Email. Convatec asked consignees to take the following actions: 1. Examine your inventory and identify all affected product lots using the lot numbers provided in the communication. 2a. (end-user) If you identify affected product, discontinue use of the affected device and contact your supplier, healthcare provider, or Convatec representative to obtain replacement product as soon as possible. If replacement product is not immediately available and continued use is necessary, follow the interim precautionary instructions. 2b. (distributor) Immediately quarantine and discontinue distribution, sale, transfer, and use of all affected product to prevent further distribution or use. 3. Inform all appropriate personnel within your organization. 4.If you have further distributed, transferred, or supplied any affected product, you must immediately notify all consignees and customers who may have received the affected product. Provide them with a copy of this recall notification and instruct them to take the actions described in this notice. 5. Please confirm receipt of this notice and your compliance with the required actions by completing and returning the enclosed acknowledgement form to us.customerservice@CONVATEC.COM no later than by August 07, 2026.

• FDA enforcement recordOfficial FDA database entry for Z-2986-2026
• FDA device classification · EXGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5900The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ConvaTec, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.