Recall Z-0147-2026
Ethicon Endo-Surgery Inc · initiated September 11, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Codes / lots: UDI-DI: 10705036030881; Lot Number: 904C12
Reason for recall
The devices were shipped unsterilized.
FDA-determined cause: Under Investigation by firm
Action taken
An IMPORTANT CUSTOMER NOTIFICATION was sent to customers beginning 9/11/25. Actions Required Complete the Business Reply Form (BRF) (Attachment 1) confirming receipt and your understanding of this notification.
Details
- Recall number
- Z-0147-2026
- Initiated
- September 11, 2025
- Posted by FDA
- October 14, 2025
- Product code
- GDW – Staple, Implantable
- Quantity
- 3 units
- Distribution
- International distribution to the countries of United Arab Emirates.
- Recalling firm
- Ethicon Endo-Surgery Inc, Blue Ash, OH