ECHELON Linear Cutters (Ethicon) – Unsterilized Devices (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Brand
Ethicon Endo-Surgery Inc
Lot Codes / Batch Numbers
UDI-DI: 10705036030881, Lot Number: 904C12
Products Sold
UDI-DI: 10705036030881; Lot Number: 904C12
Ethicon Endo-Surgery Inc is recalling ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of an due to The devices were shipped unsterilized.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The devices were shipped unsterilized.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026