Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX recall (Covidien, LP)
Medical deviceClass IIOngoing
Summary: Covidien, LP is recalling 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.
What is being recalled
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.
How to tell if yours is affected
S8698GX UDI-DI 20612479214716 Lot D5M3438FY
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2922-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 24, 2026 |
| Reported | August 19, 2026 |
| Company | Covidien, LP |
| Company location | North Haven, CT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 135,875 total |
More recalls from Covidien, LP · all medical device recalls · recalls from June 2026