FDA (Devices) recall action 97260
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Orascoptic custom loupes with Dragonfly frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 15,245 units are affected.
Orascoptic Phantom Essential Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 74 kits are affected.
Orascoptic custom loupes configured with Phantom frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 10,611 units are affected.
Orascoptic Dragonfly Essentials Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 32 kits are affected.
Orascoptic Phantom Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 22 kits are affected.
Orascoptic Dragonfly Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 743 kits are affected.