Recall Z-1584-2026 ยท FON Bag, Drainage, With Adhesive, Ostomy
ConvaTec, Inc
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
| Date | Mar 19, 2026 (initiated Feb 16, 2026) |
| Status | Open, Classified |
| Reason | Drainable large pouch may leak due to manufacturing issue. |
| Root cause | Process control |
| Action | On February XX, 2026 Convatec issued a updated Urgent Medical Device Recall Notification via E-Mail. The initial notification was issued February 16, 2026. Convatec asked consignees to take the following actions: 1. Review your personal supplies and determine if you are affected by this communication. 2. Discontinue use and dispose of the affected product. 3. Complete Response Form and return to Convatec within 30 days. 4. Acknowledgment of this action is critical. If you re not able to provide a written response liaise with your distributor or Convatec Customer Services can support. 5. |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.