Class 2 Device Recall EEA Autosuture Circular Stapler

• Date Initiated by Firm: May 13, 2022
• Create Date: July 01, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1322-2022
• Recall Event ID: 90362
• Product Classification: Stapler, surgical - Product Code GAG
• Product: EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
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• Recalling Firm/ Manufacturer: Covidien, LP; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: Medtronic Customer Service; 203-492-5000
• Manufacturer Reason for Recall: The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.
• FDA Determined Cause: Process change control
• Action: Beginning 13-MAY-2022 communications to all affected consignees began. In the United States notifications are set via UPS 2-day delivery. Customers should return all unused affected product in inventory to Medtronic. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been transferred. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.
• Quantity in Commerce: 433,560
• Distribution: Worldwide distribution - US Nationwide.
• 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.