Recall
FDAHealthJuly 3, 2025

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

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
July 3, 2025

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.

What's affected?

Product
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
Lot code
All kits manufactured between June 6, 2023 - May 14, 2025

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 22 kits..

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.