Orascoptic Surgical Acuity

FDA Regulatory Profile

Orascoptic Surgical Acuity appears in FDA public data with 6 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2444-2025, Class II) was initiated on July 3, 2025.

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2444-2025Class IIOrascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and July 3, 2025
Z-2442-2025Class IIOrascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe,July 3, 2025
Z-2445-2025Class IIOrascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 2July 3, 2025
Z-2440-2025Class IIOrascoptic Superior Visualization Custom loupes with Dragonfly framesJuly 3, 2025
Z-2441-2025Class IIOrascoptic Superior Visualization Custom loupes configured with Phantom FramesJuly 3, 2025
Z-2443-2025Class IIOrascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, sJuly 3, 2025