Recall Z-0147-2026 · GDW Staple, Implantable
Ethicon Endo-Surgery Inc
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
| Date | Oct 14, 2025 (initiated Sep 11, 2025) |
| Status | Open, Classified |
| Reason | The devices were shipped unsterilized. |
| Root cause | Under Investigation by firm |
| Action | An IMPORTANT CUSTOMER NOTIFICATION was sent to customers beginning 9/11/25. Actions Required Complete the Business Reply Form (BRF) (Attachment 1) confirming receipt and your understanding of this notification. |
| Quantity | 3 units |
| Distribution | International distribution to the countries of United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON Ethicon Endo-Surgery, Mar 15, 2023 |