FDA Enforcement
Class II
Ongoing
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Recall: Z-0147-2026
·
Reported October 22, 2025
Enforcement
- Recall Number
- Z-0147-2026
- Event ID
- 97654
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ethicon Endo-Surgery Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 22, 2025
- Initiation Date
- September 11, 2025
- Classification Date
- October 14, 2025
- Address
- 4545 Creek Rd, Blue Ash, OH, 45242-2803, United States
Description
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.
Code Info
UDI-DI: 10705036030881; Lot Number: 904C12
Distribution
International distribution to the countries of United Arab Emirates.
Quantity
3 units