Recall Z-2442-2025— Orascoptic Surgical Acuity

Name: FDA recall Z-2442-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-03

Class II · Ongoing

Class II FDA medical device recall by Orascoptic Surgical Acuity, initiated 2025-07-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver). Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction..

Recalling firm: Orascoptic Surgical Acuity
Classification: Class II
Status: Ongoing
Initiated: 2025-07-03
Firm location: Orange, CA, United States

Product description

Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

Reason for recall

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

Data sourced from openFDA. This site is unofficial and independent of the FDA.