Z-0147-2026 Class II Ongoing
FDA device recall Z-0147-2026 was initiated by Ethicon Endo-Surgery Inc on September 11, 2025 and is designated Class II. Reason for recall: The devices were shipped unsterilized. The recall status is ongoing. Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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.
Distribution Pattern
International distribution to the countries of United Arab Emirates.
Code Information
UDI-DI: 10705036030881; Lot Number: 904C12