Recall Z-2922-2026 ยท GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Covidien, LP
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
| Date | Aug 7, 2026 (initiated Jun 24, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 reca |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE United States Surgical, A Division of Tyco Healthc, Jun 1, 2005 |