Recall Z-2441-2025— Orascoptic Surgical Acuity
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 Custom loupes configured with Phantom Frames. 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 Custom loupes configured with Phantom Frames
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.