Covidien, LP: Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Covidien, LP
- Product
- Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-06-24
- Code info
- S8698GX UDI-DI 20612479214716 Lot D5M3438FY
- Product quantity
- 135,875 total
- Voluntary mandated
- Voluntary: Firm initiated
- City
- North Haven
- State
- CT
- Country
- United States
- Event id
- 99390
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