🔍 RecallPedia

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Class I - Dangerous
🏥 Medical Devices Recalled: April 18, 2024 Olympus Corporation of the Americas Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;
  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:
Olympus Corporation of the Americas
Reason for Recall:
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Product Codes/Lot Numbers:

Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2029-2024

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