Z-2441-2025 Class II Ongoing
FDA device recall Z-2441-2025 was initiated by Orascoptic Surgical Acuity on July 3, 2025 and is designated Class II. Reason for recall: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. The recall status is ongoing. Affected quantity: 10,611 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- July 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,611 units
Product Description
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Reason for Recall
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
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.
Code Information
All serial numbers manufactured between June 6, 2023 - May 14, 2025