Official recall notice
FDA DeviceClass IINotable
FDA Recall: Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
- 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
SP-623 UDI-DI 20884521037073 Lot D6A2963Y