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FDA (Device enforcement)Recalled 2025-07-03class ii

Orascoptic Surgical Acuity: Orascoptic Superior Visualization Custom loupes with Dragonfly frames

Hazard

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

Details from the source

Reason for recall: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. 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, P Quantity: 15,245 units Lot/code info: All Serial numbers manufactured between September 7, 2023 - May 14, 2025

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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