FDAFDA · Food and drugs·Recall number Z-2442-2025
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Published September 3, 2025 · Recall initiated: July 3, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Orascoptic Surgical Acuity
- Distributor
- 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.
- Lot
- All kits manufactured between June 6, 2023 - May 14, 2025
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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