Agency classClass IIOur severity:High FDA (Devices)·Z-2441-2025·Announced 2025-09-03

Custom loupes with Phantom frames recalled over nickel nose pad allergy risk

Orascoptic custom loupes configured with Phantom frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 10,611 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 configured with Phantom frames are being recalled. All serial numbers manufactured between June 6, 2023 and May 14, 2025 are covered. The recall involves 10,611 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 configured with Phantom Frames
Manufacturer: Orascoptic Surgical Acuity
Category: Medical Device — Dental Equipment
Hazard: allergic-reaction-risk
nickel
loupes
class-ii
Affected units: 10,611

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 June 6
2023 - May 14
2025

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

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 →

Same manufacturer · Orascoptic Surgical Acuity

See all →

High
Custom loupes with Dragonfly frames recalled over nickel nose pad allergy risk
FDA (Devices) · 2025-09-03
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Phantom Essential loupe kits recalled because nickel nose pads may cause allergy
FDA (Devices) · 2025-09-03
High
Dragonfly Essentials loupe kits recalled because nickel nose pads may cause allergy
FDA (Devices) · 2025-09-03
High
Phantom nose pad kits recalled because nickel content may cause allergic reaction
FDA (Devices) · 2025-09-03
High
Loupe nose pad kits recalled because nickel content may cause allergic reaction
FDA (Devices) · 2025-09-03

Same hazard · allergic reaction risk