TemporaryFDAOngoing
Can cause harm that is usually temporary.
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Check the device or its packaging for
S8698GX UDI-DI 20612479214716 Lot D5M3438FY
- Why
- 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.
- Distributed
- 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.
- Company
- Covidien, LP
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2922-2026 · retrieved 7 August 2026
Read the official notice