ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product N

FDA device recall Z-0147-2026 · posted 2025-10-14 · Open, Classified

Recall details

Recalling firm: Ethicon Endo-Surgery Inc
Reason for recall: The devices were shipped unsterilized.
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.
Root cause: Under Investigation by firm
Status: Open, Classified
Product code: GDW
Quantity affected: 3 units
Distribution: International distribution to the countries of United Arab Emirates.
Date initiated: 2025-09-11
Date posted: 2025-10-14
Location: Blue Ash, OH

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) (K223760)	Ethicon Endo-Surgery	2023-03-15