Recall
FDAHealthJune 24, 2026

Covidien, LP — Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 24, 2026

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.

What's affected?

Product
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Lot code
D5M3438FY

Additional details

S8698GX UDI-DI 20612479214716 Lot D5M3438FY

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 135,875 total.

View original FDA notice →

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