Class 2 Device Recall ECHELON LINEAR Cutters

• Date Initiated by Firm: September 11, 2025
• Date Posted: October 14, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0147-2026
• Recall Event ID: 97654
• 510(K)Number: K223760
• Product Classification: Staple, implantable - Product Code GDW
• Product: ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
• Code Information: UDI-DI: 10705036030881; Lot Number: 904C12
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery Inc; 4545 Creek Rd; Blue Ash OH 45242-2803
• For Additional Information Contact: 513-337-7000
• Manufacturer Reason for Recall: The devices were shipped unsterilized.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 3 units
• Distribution: International distribution to the countries of United Arab Emirates.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GDW