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Orascoptic Surgical Acuity recalls Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Recalled September 3, 2025 · FDA recall Z-2441-2025 · Orascoptic Surgical Acuity
Hazard
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. · FDA Class II
Units
10,611 units
Sold at
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.
Description
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Product
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Manufacturer(s)
Orascoptic Surgical Acuity
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →