ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of...
FDA Recall #Z-0147-2026 — Class II — September 11, 2025
Product Description
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Reason for Recall
The devices were shipped unsterilized.
Recalling Firm
Ethicon Endo-Surgery Inc — Blue Ash, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 units
Distribution
International distribution to the countries of United Arab Emirates.
Code Information
UDI-DI: 10705036030881; Lot Number: 904C12
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated