Orascoptic Phantom Nose Pad Kits Recalled for Nickel Allergy Risk
Orascoptic nose pad kits may contain nickel that could cause allergic reactions. The affected kits were manufactured between June 2023 and May 2025 and distributed nationwide and internationally.
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 medical device recall involving nickel, a common allergen. No illnesses or injuries have been reported. Per the severity rubric, allergen-related product hazards without reported illness are classified as High (score 3).
Plain-English summary
Orascoptic Surgical Acuity is recalling Phantom Nose Pad Accessory Kits because the nose pads may contain nickel, which can cause allergic reactions.
The recall affects 22 kits manufactured between June 6, 2023 and May 14, 2025. Distribution was worldwide, including all U.S. states and territories, and multiple international locations.
The recalled product
- Product
- Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
- 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 kits manufactured between June 6
- 2023 - May 14
- 2025
Distribution
Distributed nationwide across the United States.
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