Orascoptic Surgical Acuity: Device Recall
Recall #Z-2441-2025 · 07/03/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2441-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Orascoptic Surgical Acuity
- Status
- Ongoing
- Date Initiated
- 07/03/2025
- Location
- Orange, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,611 units
Reason for Recall
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Product Description
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
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.
Other Recalls by Orascoptic Surgical Acuity
- Class II: Risk 07/03/2025
- Class II: Risk 07/03/2025
- Class II: Risk 07/03/2025
- Class II: Risk 07/03/2025
- Class II: Risk 07/03/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.