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
- Brand
- Covidien, LP
- 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.
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