Official recall notice
FDA DeviceClass IINotable
FDA Recall: 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.
Recommended action
What to do
135,875 total
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.