Agency classClass IIOur severity:High FDA (Devices)·Z-2443-2025·Announced 2025-09-03

Phantom Essential loupe kits recalled because nickel nose pads may cause allergy

Orascoptic Phantom Essential Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 74 kits 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

The Orascoptic Superior Visualization Phantom Essential Kit, containing a nose pad, a screw, a lens cleaning wipe, side shields, a head strap and a screwdriver, is being recalled. All kits manufactured between June 6, 2023 and May 14, 2025 are covered. The recall involves 74 kits 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 kits 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 Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Manufacturer: Orascoptic Surgical Acuity
Category: Medical Device — Dental Equipment
Hazard: allergic-reaction-risk
nickel
accessory-kit
class-ii
Affected units: 74

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.

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 →

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