Device recall

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

FDA recall source

Recall number

Z-2922-2026

Event id

99390

Status

Ongoing

FDA classification

Class II

Recalling firm

Covidien, LP

Report date

Aug 19, 2026

Initiated

Jun 24, 2026

Center classification date

Aug 7, 2026

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.

Quantity

135,875 total

Code info

S8698GX UDI-DI 20612479214716 Lot D5M3438FY

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.

Voluntary or mandated

Voluntary: Firm initiated

Location

North Haven, CT, United States