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Recall Observatory FDA recall evidence

Device product

Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.

Z-2445-2025

July 03, 2025

Class II

Product summary

Firm
Orascoptic Surgical Acuity
Event
Event 97260
Status
Ongoing
Classification
Class II
Quantity
22 kits.
Official record key
device-enforcement:Z-2445-2025

Official wording

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

Code information: All kits manufactured between June 6, 2023 - May 14, 2025

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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