🔍 RecallPedia

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

Class I - Dangerous
🏥 Medical Devices Recalled: July 3, 2025 Orascoptic Surgical Acuity Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All serial numbers manufactured between June 6, 2023 - May 14, 2025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Orascoptic Surgical Acuity
Reason for Recall:
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

Product Codes/Lot Numbers:

All serial numbers manufactured between June 6, 2023 - May 14, 2025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2441-2025

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