Recall Z-2986-2026 ยท EXG Bag, Urine Collecting, Ureterostomy
ConvaTec, Inc
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.
| Date | Aug 19, 2026 (initiated Jul 6, 2026) |
| Status | Open, Classified |
| Reason | Urostomy Pouches may leak from cap during use. |
| Root cause | Material/Component Contamination |
| 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 th |
| Quantity | 617850 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.