Reported Sep 3, 2025 · Ongoing
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Orascoptic Surgical Acuity
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orascoptic Surgical Acuity · 717 W Collins Ave · Orange, CA · 92867-5513
Is this the product you have?
- Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
- Lot codes and dates
- All serial numbers manufactured between June 6, 2023 - May 14, 2025
- Amount recalled
- 10,611 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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