PlainRecalls
FDA Devices Moderate Class II Ongoing

Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

Reported: September 3, 2025 Initiated: July 3, 2025 #Z-2442-2025

Product Description

Orascoptic Superior Visualization Dragonfly Essentials 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.

Details

Units Affected
32 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.
Location
Orange, CA

Frequently Asked Questions

What product was recalled?
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver). Recalled by Orascoptic Surgical Acuity. Units affected: 32 kits.
Why was this product recalled?
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 3, 2025. Severity: Moderate. Recall number: Z-2442-2025.