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Orascoptic Surgical Acuity recalls Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head st
Recalled September 3, 2025 · FDA recall Z-2443-2025 · Orascoptic Surgical Acuity
Hazard
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. · FDA Class II
Units
74 kits
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 Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Manufacturer(s)
Orascoptic Surgical Acuity
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →