Recall Z-2444-2025— Orascoptic Surgical Acuity

Name: FDA recall Z-2444-2025
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 Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.. 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 Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.

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.