Orascoptic Custom Loupes Recall: Nickel Allergic Reaction Risk

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Recalling firmOrascoptic Surgical Acuity717 W Collins Ave · Orange, CA 92867-5513

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Orascoptic is recalling custom loupes that come with Phantom Frames because they may contain nickel, which can cause allergic reactions. This affects users who bought these loupes between June 6, 2023, and May 14, 2025.

Why it’s dangerous

The loupe nose pads may contain nickel, a metal that can cause allergic reactions in some people. This is a potential health risk for individuals sensitive to nickel, though it does not cause serious injury in normal use.

Who’s affected

Users who purchased Orascoptic Superior Visualization Custom loupes with Phantom Frames between June 6, 2023, and May 14, 2025 are most at risk. People with nickel allergies are particularly vulnerable.

How to tell if you have this one

Check for the product name 'Orascoptic Superior Visualization Custom loupes' with Phantom Frames. The recall covers all units made between June 6, 2023, and May 14, 2025.

Brand
Orascoptic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately stop using the loupes if you have nickel allergies or experience skin irritation.

✎ GovInfoNow

Questions people ask

Do I need to return these loupes?

The recall record does not specify a return process, so contact Orascoptic directly for instructions.

When were these loupes made?

The loupes were manufactured between June 6, 2023, and May 14, 2025.

Are there any safety risks for people without nickel allergies?

The recall record states that the risk is only for people with nickel allergies, so no significant risk exists for others.

Take action

Contact Orascoptic

We’ve drafted a message you can send Orascoptic to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2441-2025 — Orascoptic Orascoptic

Hello,

I own a Orascoptic that is covered by recall Z-2441-2025 from Orascoptic.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2441-2025 (July 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2441-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Orascoptic Surgical Acuity recalls Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

Lower-risk recall