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Orascoptic Surgical Acuity FDA Recalls

6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head Class IIJul 3, 2025Due to complaints, loupe nose pads containing nickel may cau
Orascoptic Superior Visualization Custom loupes configured with Phantom FramesClass IIJul 3, 2025Due to complaints, loupe nose pads containing nickel may cau
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.Class IIJul 3, 2025Due to complaints, loupe nose pads containing nickel may cau
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.Class IIJul 3, 2025Due to complaints, loupe nose pads containing nickel may cau
Orascoptic Superior Visualization Custom loupes with Dragonfly framesClass IIJul 3, 2025Due to complaints, loupe nose pads containing nickel may cau
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head stClass IIJul 3, 2025Due to complaints, loupe nose pads containing nickel may cau

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