Class 2 Device Recall ECHELON Endopath Stapler

• Date Initiated by Firm: December 11, 2023
• Date Posted: January 26, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0834-2024
• Recall Event ID: 93735
• 510(K)Number: K163454
• Product Classification: Staple, implantable - Product Code GDW
• Product: ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
• Code Information: UDI-DI 10705036014928 Lots 442C02 and 442C03
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery Inc; 4545 Creek Rd; Blue Ash OH 45242-2803
• For Additional Information Contact: Ethicon Resource Department; 877-384-4266
• Manufacturer Reason for Recall: There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
• FDA Determined Cause: Under Investigation by firm
• Action: On December 11, 2023, the firm notified affected consignees through URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters. Customers were instructed to cease use and distribution of affected product lots. Customers should examine their inventory immediately to determine if they have affected product. Affected product should be quarantined. Unused affected product should be returned. If you require any assistance with returning product, please contact Sedgwick at 888-591-5087 and reference Event # 6925. If you have additional questions regarding this voluntary medical device recall, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.
• Quantity in Commerce: 22,616 (US), 4,476 (OUS)
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
• 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