Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe...
FDA Recall #Z-2443-2025 — Class II — July 3, 2025
Product Description
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
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
74 kits
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 kits 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.