Orange, CA, United States
Orascoptic Surgical Acuity recalls
1 recall recorded since 2018, most recently on 3 July 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 July 2025
- Reason
- Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
- 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, C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2442-2025, Z-2445-2025, Z-2444-2025, Z-2440-2025, Z-2441-2025, Z-2443-2025
- Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
- Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
- Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
- Orascoptic Superior Visualization Custom loupes with Dragonfly frames
- Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
- Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.