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Open, Classified

Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

FDA Recall Z-2921-2026 · Posted 2026-08-07

Recalling FirmCovidien, LP
Recall StatusOpen, Classified
Product CodeGAW
Date Initiated2026-06-24
Product Quantity135,875 total

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.

Firm 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.

Root Cause

Equipment maintenance

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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