Z-2445-2025 Class II Ongoing
FDA device recall Z-2445-2025 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: 22 kits..
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
- 22 kits.
Product Description
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
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 kits manufactured between June 6, 2023 - May 14, 2025