FDA Device recall Z-0147-2026
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80 by Ethicon Endo Surgery, citing the devices were shipped unsterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0147-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-11 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | n/a |
Product
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Reason
The devices were shipped unsterilized.
Identifiers
| code_info | UDI-DI: 10705036030881; Lot Number: 904C12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0147-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.