← FDA ENFORCEMENT
Z-0147-2026Class II
Ethicon Endo-Surgery Inc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Ethicon Endo-Surgery Inc
Product type
Device
Status
Ongoing
Report date
2025-10-22
Distribution
International distribution to the countries of United Arab Emirates.
Firm state
OH
Product quantity
3 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
The devices were shipped unsterilized.
Product description
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Code / lot info
UDI-DI: 10705036030881; Lot Number: 904C12
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →