Medical DeviceSep 3, 2025
Orascoptic Superior Visualization Dragonfly Essentials Kit recall — FDA Z-2442-2025
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class IIFDA: OngoingOrascoptic Surgical Acuity
Recall history in this database
Classification mix: Class II: 6.
Medical DeviceSep 3, 2025
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. recall — FDA Z-2445-2025
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class IIFDA: OngoingOrascoptic Surgical Acuity
Medical DeviceSep 3, 2025
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 recall — FDA Z-2444-2025
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class IIFDA: OngoingOrascoptic Surgical Acuity
Medical DeviceSep 3, 2025
Orascoptic Superior Visualization Custom loupes with Dragonfly frames recall — FDA Z-2440-2025
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class IIFDA: OngoingOrascoptic Surgical Acuity
Medical DeviceSep 3, 2025
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames recall — FDA Z-2441-2025
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class IIFDA: OngoingOrascoptic Surgical Acuity
Medical DeviceSep 3, 2025
Orascoptic Superior Visualization Phantom Essential kit recall — FDA Z-2443-2025
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class IIFDA: OngoingOrascoptic Surgical Acuity
Understanding this recall history
This page summarizes recall records in which the official source identifies Orascoptic Surgical Acuity as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.