Class 2 Device Recall Surgipro

• Date Initiated by Firm: June 24, 2026
• Date Posted: August 07, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2922-2026
• Recall Event ID: 99390
• 510(K)Number: K050947
• Product Classification: Suture, nonabsorbable, synthetic, polypropylene - Product Code GAW
• Product: Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
• Code Information: S8698GX UDI-DI 20612479214716 Lot D5M3438FY
• 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: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
• FDA Determined Cause: Equipment maintenance
• Action: The firm began notifying consignees on 7/7/26 via email, mail, or electronically. Notices were titled, "URGENT: VOLUNTARY MEDICAL DEVICE RECALL." Customers were informed of the manufacturing nonconformance. If products in scope of this field action have been used in patients under the customer's care, the customer is instructed to monitor for signs of infection or vision issues due to the possibility of biocontamination. Customers were instructed to immediately identify, cease use, and quarantine all unused impacted product. Unused impacted product is to be returned to Medtronic. The recall notice should be passed on to all those who need to be aware within the customer's organization or to any organization where devices have been transferred.
• Quantity in Commerce: 135,875 total
• Distribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
• 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 = GAW