Custom loupes with Dragonfly frames recalled over nickel nose pad allergy risk
Orascoptic custom loupes with Dragonfly frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 15,245 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes a potential allergic reaction to nickel without reporting injuries.
Plain-English summary
Orascoptic Superior Visualization custom loupes with Dragonfly frames are being recalled. All serial numbers manufactured between September 7, 2023 and May 14, 2025 are covered. The recall involves 15,245 units distributed nationwide in the United States and internationally.
Following complaints, the manufacturer determined that loupe nose pads containing nickel may cause an allergic reaction. The FDA classified the action as Class II.
Users holding affected loupes should follow the manufacturer's instructions for return or replacement, and should speak to a clinician about any skin reaction.
The recalled product
- Product
- Orascoptic Superior Visualization Custom loupes with Dragonfly frames
- Manufacturer
- Orascoptic Surgical Acuity
- Affected units
- 15,245
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
Part of a larger recall action
This product is one of 6 recalled by Orascoptic Surgical Acuity under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Orascoptic Surgical Acuity
See all →- HighPhantom Essential loupe kits recalled because nickel nose pads may cause allergy
FDA (Devices) · 2025-09-03
- HighCustom loupes with Phantom frames recalled over nickel nose pad allergy risk
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- HighDragonfly Essentials loupe kits recalled because nickel nose pads may cause allergy
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- HighPhantom nose pad kits recalled because nickel content may cause allergic reaction
FDA (Devices) · 2025-09-03
- HighLoupe nose pad kits recalled because nickel content may cause allergic reaction
FDA (Devices) · 2025-09-03
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