Orascoptic Surgical Acuity: Medical Device Recall in 2025 - (Recall #: Z-2440-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Orascoptic Superior Visualization Custom loupes with Dragonfly frames

Product Classification:

Class II

Date Initiated: July 3, 2025

Date Posted: September 3, 2025

Recall Number: Z-2440-2025

Event ID: 97260

Reason for Recall:

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

Status: Ongoing

Product Quantity: 15,245 units

Code Information:

All Serial numbers manufactured between September 7, 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.

Voluntary or Mandated:

Voluntary: Firm initiated