🔍 RecallPedia

OPMI LUMERA 300, REF 6137

Class I - Dangerous
🏥 Medical Devices Recalled: August 18, 2023 Carl Zeiss Suzhou Co. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613
  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:
Carl Zeiss Suzhou Co., Ltd.
Reason for Recall:
Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

OPMI LUMERA 300, REF 6137

Product Codes/Lot Numbers:

UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0183-2024