Official recall notice
FDA DeviceClass IINotable
FDA Recall: Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 7
- 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
88861757-31 UDI-DI 10884521070912 Lot D6A3020FY UDI-DI 20884521070919 Lot D6A3020FY 88861799-31 UDI-DI 20884521071060 Lot D6A2861FY