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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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High RiskFDA Device
Medical Devices/Surgical Equipment

Carl Zeiss Suzhou Co., Ltd.: OPMI LUMERA 300 Surgical Microscope Recalled for Risk of Falling Components

Agency Publication Date: October 26, 2023
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Summary

Carl Zeiss Suzhou Co., Ltd. has recalled 8 units of the OPMI LUMERA 300 surgical microscope, model REF 6137, because a screw may be missing from the suspension arm. This defect can cause the heavy microscope components to detach and fall during medical procedures. These devices were distributed across Maryland, Texas, California, Georgia, and Louisiana. If you are a healthcare facility using this equipment, you should immediately contact the manufacturer to verify the safety of your unit.

Risk

A missing screw in the suspension arm allows the surgical microscope's suspended components to become unstable and potentially fall on patients or medical staff. This poses a significant risk of impact injuries to anyone positioned beneath the device during an ophthalmic surgery.

What You Should Do

  1. Identify your device by checking for the model OPMI LUMERA 300, REF 6137.
  2. Check the serial number on your device's identification plate to see if it matches any of the following 8 affected numbers: 6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, or 6137104613.
  3. Check for UDI-DI 06909262061375 on the product labeling.
  4. Contact your healthcare provider or Carl Zeiss Suzhou Co., Ltd. immediately for further instructions regarding the inspection and repair of the suspension arm.
  5. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer inspection and corrective action

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

Affected Products

Product: OPMI LUMERA 300, REF 6137
Model / REF:
REF 6137
UPC Codes:
06909262061375
Lot Numbers:
6137104455
6137104627
6137104623
6137104678
6137104233
6137104620
6137104480
6137104613

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93146
Status: Active
Manufacturer: Carl Zeiss Suzhou Co., Ltd.
Sold By: Carl Zeiss Suzhou Co., Ltd.; Authorized Medical Distributors
Manufactured In: China
Units Affected: 8
Distributed To: Maryland, Texas, California, Georgia, Louisiana

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.