Orascoptic Custom Surgical Loupes Recalled for Potential Nickel Allergy Reactions
Orascoptic custom surgical loupes are being recalled because their nose pads contain nickel, which may cause allergic reactions in people with nickel sensitivity.
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 recall for a common allergen (nickel) with no documented hospitalizations or injury reports mentioned in the source. The recall addresses a potential allergic reaction hazard identified through customer complaints, meeting the criteria for a risk-of-harm product without reported injuries.
Plain-English summary
Orascoptic Surgical Acuity is recalling Orascoptic Superior Visualization Custom loupes with Dragonfly frames because the loupe nose pads contain nickel, which may cause allergic reactions in individuals with nickel sensitivity. The recall was initiated following complaints received about this issue.
The affected loupes have serial numbers manufactured between September 7, 2023, and May 14, 2025. Approximately 15,245 units were distributed worldwide, including throughout the United States and internationally.
Individuals who wear these loupes and have nickel allergies or sensitivity are at risk of experiencing an allergic reaction when the nose pads make contact with their skin. This risk is particularly relevant for healthcare professionals and others who wear these loupes frequently.
Consumers who own the recalled loupes should discontinue use and contact Orascoptic Surgical Acuity for instructions on return or replacement options. Anyone who has experienced symptoms of an allergic reaction should consult with a healthcare provider.
The recalled product
- Product
- Orascoptic Superior Visualization Custom loupes with Dragonfly frames
- Manufacturer
- Orascoptic Surgical Acuity
- Category
- Medical Device — Surgical loupes
- 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 September 7
- 2023 - May 14
- 2025
Distribution
Distributed nationwide across the United States.
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