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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Orascoptic Surgical Acuity: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

Agency Publication Date: August 26, 2025
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Summary

Orascoptic Surgical Acuity is recalling approximately 15,245 pairs of Orascoptic Superior Visualization Custom loupes with Dragonfly frames because the nose pads contain nickel. These surgical loupes were manufactured between September 7, 2023, and May 14, 2025, and have been distributed worldwide. Consumers should be aware that the nickel in the nose pads can trigger allergic reactions in sensitive individuals.

Risk

The nose pads of these loupes contain nickel, which can cause an allergic skin reaction or contact dermatitis when it comes into direct contact with the user's skin. The firm has received complaints regarding these reactions.

What You Should Do

  1. Check your device frames to determine if they are the Orascoptic Superior Visualization Custom loupes with Dragonfly frames.
  2. Identify if your loupes were manufactured between September 7, 2023, and May 14, 2025, by checking your serial number against the production date range.
  3. If you are experiencing skin irritation or have a known nickel allergy, contact Orascoptic Surgical Acuity or your healthcare provider for further instructions regarding the use of these loupes.
  4. Contact Orascoptic Surgical Acuity to discuss potential remedies or replacement parts for the affected nose pads.
  5. If you have additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Consultation with manufacturer or healthcare provider

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Orascoptic Superior Visualization Custom loupes with Dragonfly frames
Lot Numbers:
All Serial numbers manufactured between September 7, 2023 - May 14, 2025
Date Ranges: Manufactured September 7, 2023 - May 14, 2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97260
Status: Active
Manufacturer: Orascoptic Surgical Acuity
Manufactured In: United States
Units Affected: 6 products (15,245 units; 10,611 units; 32 kits; 74 kits; 743 kits; 22 kits.)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.