Class 2 Device Recall Covidien EndoStitch"

• Date Initiated by Firm: April 15, 2026
• Date Posted: June 01, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2281-2026
• Recall Event ID: 98871
• 510(K)Number: K934738
• Product Classification: Endoscopic tissue approximation device - Product Code OCW
• Product: Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071
• Code Information: 1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y
• FEI Number: 1219930
• Recalling Firm/ Manufacturer: Covidien, LP; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: Medtronic Technical Services; 800-255-6774
• Manufacturer Reason for Recall: The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
• FDA Determined Cause: Process control
• Action: On April 23, 2026 URGENT: VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Customer actions: - Immediately identify and quarantine all unused impacted product listed above. - See Appendix A for guidance on identifying affected lots. - This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Return all unused impacted product listed above to Medtronic. Medtronic Actions: - Medtronic representatives will assist customers with the return of affected product, upon request. - Medtronic representatives will work with customers to ensure replacement products are available to avoid interruptions in patient care.
• Quantity in Commerce: 2448 units
• Distribution: Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy
• 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 = OCW