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Home › FDA recalls › Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
CLASS II · ModerateFDA

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

📅 Jun 24, 2026 · 📍 Nationwide
Recalling company
Covidien, LP
Product
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jun 24, 2026
Reported
Aug 19, 2026
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.
Status
Ongoing
Quantity
135,875 total
Lot / codes
S8698GX UDI-DI 20612479214716 Lot D5M3438FY
Company location
North Haven, CT
Recall type
Voluntary: Firm initiated
Recall number
Z-2922-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2922-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.