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Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

FDA Recall #Z-2441-2025 — Class II — July 3, 2025

Recall #Z-2441-2025 Date: July 3, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

Orascoptic Surgical Acuity — Orange, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

10,611 units

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.

Code Information

All serial numbers manufactured between June 6, 2023 - May 14, 2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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