Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
Reported: September 3, 2025 Initiated: July 3, 2025 #Z-2445-2025
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.
Details
- Recalling Firm
- Orascoptic Surgical Acuity
- Units Affected
- 22 kits.
- 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.
- Location
- Orange, CA
Frequently Asked Questions
What product was recalled? ▼
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.. Recalled by Orascoptic Surgical Acuity. Units affected: 22 kits..
Why was this product recalled? ▼
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2025. Severity: Moderate. Recall number: Z-2445-2025.
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