Loupe Recall: Orascoptic Dragonfly Essentials Kit
Announced 2025-09-03 · FDA
The FDA is recalling 74 Orascoptic Superior Visualization Dragonfly Essentials Kit due to nickel-containing loupe nose pads that may cause an allergic reaction. The recall covers worldwide distribution, including the United States; all affected kits were manufactured between June 6, 2023 and May 14, 2025. No corrective action is provided.
| Brand | Orascoptic Surgical Acuity |
|---|---|
| Product | Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver) |
| Reason | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| Severity | moderate |
| Units affected | 32 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | All kits manufactured between June 6, 2023 - May 14, 2025 |
WHAT YOU SHOULD DO
- Stop using the kit immediately.
- If you own an affected kit (manufactured between 6/6/2023 and 5/14/2025), contact Orascoptic for remedy instructions and return or replacement options.
- Follow any instructions from the FDA or Orascoptic for disposal or return of the product.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.