FDA · Medical devices ·
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX recall
Covidien, LP recalled Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX on August 19, 2026 because of product may contain a perforation or tear in the sterile barrier packaging. It was sold nationwide.
Why it was recalled
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.
What's recalled
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Quantity: 135,875 total
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Covidien, LP, North Haven, CT
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
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,… - Status
- Ongoing
- Recall number
- Z-2922-2026
- Source
- U.S. Food and Drug Administration
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