Custom loupes with Phantom frames recalled over nickel nose pad allergy risk
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes a potential allergic reaction to nickel without reporting injuries.
Plain-English summary
Orascoptic Superior Visualization custom loupes configured with Phantom frames are being recalled. All serial numbers manufactured between June 6, 2023 and May 14, 2025 are covered. The recall involves 10,611 units distributed nationwide in the United States and internationally.
Following complaints, the manufacturer determined that loupe nose pads containing nickel may cause an allergic reaction. The FDA classified the action as Class II.
Users holding affected loupes should follow the manufacturer's instructions for return or replacement, and should speak to a clinician about any skin reaction.
The recalled product
- Product
- Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
- Manufacturer
- Orascoptic Surgical Acuity
- Hazard
- allergic-reaction-risk
- nickel
- loupes
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All serial numbers manufactured between June 6
- 2023 - May 14
- 2025
Distribution
Distributed nationwide across the United States.
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