Official recall notice
FDA DeviceClass IINotable
Surgipro II Recall (Aug 2026) – Covidien
Product: Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
- Recall date
- 2026-08-19
- Brand
- Covidien, LP
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
S8698GX UDI-DI 20612479214716 Lot D5M3438FY