Orascoptic Surgical Acuity recalls Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

Recall date

July 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2441-2025

FDA classification

Class II

Brand / firm

Orascoptic Surgical Acuity

Sold / distributed

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, C…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames