Surgical Loupes Recalled Due to Nickel Allergy Risk in Nose Pads
Orascoptic Surgical Acuity is recalling 74 Orascoptic Superior Visualization Phantom Essential kits because the nose pads contain nickel, which may cause allergic reactions in users with nickel sensitivity. The kits were manufactured between June 6, 2023, and May 14, 2025.
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: FDA Class II classification applies. The recall addresses a potential allergen hazard (nickel) without reported hospitalizations or illnesses in the source text. The product poses a risk of harm to individuals with nickel sensitivity through direct skin contact.
Plain-English summary
Orascoptic Surgical Acuity is recalling 74 Orascoptic Superior Visualization Phantom Essential kits manufactured between June 6, 2023, and May 14, 2025. Each kit contains surgical loupes with nose pads, a screw, lens cleaning wipe, side shields, head strap, and screwdriver.
The kits are being recalled due to complaints that the loupe nose pads contain nickel, which may cause allergic reactions in individuals with nickel sensitivity. Skin contact with the nickel-containing pads during use creates exposure potential for users with nickel allergies.
The affected kits were distributed nationwide throughout the United States and internationally to multiple countries.
Users with a known nickel allergy or sensitivity should be aware of this potential reaction hazard from using these kits.
The recalled product
- Product
- Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
- 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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