Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk a...

FDA Device Recall #Z-2444-2025 — Class II — July 3, 2025

Recall Summary

Recall Number Z-2444-2025
Classification Class II — Moderate risk
Date Initiated July 3, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Orascoptic Surgical Acuity
Location Orange, CA
Product Type Devices
Quantity 743 kits

Product Description

Orascoptic Superior Visualization Dragonfly 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.

Lot / Code Information

All kits manufactured between June 6, 2023 - May 14, 2025

Other Recalls from Orascoptic Surgical Acuity

Recall # Classification Product Date
Z-2442-2025 Class II Orascoptic Superior Visualization Dragonfly Es... Jul 3, 2025
Z-2445-2025 Class II Orascoptic Superior Visualization Phantom Nose... Jul 3, 2025
Z-2440-2025 Class II Orascoptic Superior Visualization Custom loupe... Jul 3, 2025
Z-2441-2025 Class II Orascoptic Superior Visualization Custom loupe... Jul 3, 2025
Z-2443-2025 Class II Orascoptic Superior Visualization Phantom Esse... Jul 3, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.