Recall StatusOpen, Classified
Date Initiated2026-07-06
Product Quantity617850 units
Reason for Recall
Urostomy Pouches may leak from cap during use.
Firm Action
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
[email protected] no later than by August 07, 2026.
Root Cause
Material/Component Contamination
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.