Orascoptic surgical loupes recalled due to nickel allergy risk
Orascoptic Surgical Acuity is recalling surgical loupes with Phantom Frames because the nickel in the nose pads can cause allergic reactions. The recall affects 10,611 units distributed worldwide.
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: This is an FDA Class II recall involving a common allergen (nickel) in a medical device. While complaints of allergic reactions have been reported, the source text does not reference hospitalizations or serious injuries, meeting criteria for High severity.
Plain-English summary
Orascoptic Surgical Acuity is recalling Orascoptic Superior Visualization Custom loupes configured with Phantom Frames due to complaints of allergic reactions caused by nickel contained in the loupe nose pads.
The affected devices have serial numbers manufactured between June 6, 2023, and May 14, 2025. Approximately 10,611 units were distributed worldwide, including throughout the United States and internationally.
Users who experience signs of allergic reaction—such as skin irritation, redness, or itching where the loupe nose pads contact the face—should discontinue use and contact a healthcare provider if symptoms persist. For information about remedies or replacements, users should contact Orascoptic Surgical Acuity.
The recalled product
- Product
- Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
- Manufacturer
- Orascoptic Surgical Acuity
- Hazard
- allergen-nickel
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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