Surgical Loupes with Nickel-Containing Nose Pads Recalled for Allergic Reaction Risk
Orascoptic Surgical Acuity is recalling Dragonfly Essentials Kits because the nose pads may contain nickel, which can 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: This FDA Class II recall involves a common allergen (nickel) in a medical device. While complaints indicate adverse reactions have occurred, no hospitalizations or serious injuries are explicitly reported in the source material. The recall meets the high-severity criterion as a risk-of-harm product with known allergen exposure.
Plain-English summary
Orascoptic Surgical Acuity is recalling the Dragonfly Essentials Kit, which includes a surgical loupe with nose pad, screw, lens cleaning wipe, side shields, head strap, and screwdriver. The recall was initiated due to complaints that nose pads may contain nickel, which can cause allergic reactions in individuals with nickel sensitivity.
32 kits manufactured between June 6, 2023 and May 14, 2025 have been distributed nationwide in the United States and internationally.
If you have this product and have a known nickel allergy or experience allergic symptoms, discontinue use immediately and contact the manufacturer for return or replacement instructions. Consult with a healthcare provider if you develop any allergic symptoms such as rash, itching, or skin irritation where the nose pad contacts your skin.
The recalled product
- Product
- Orascoptic Superior Visualization Dragonfly Essentials 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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