Olympus Acknowledges FDA Import Alerts for Certain Devices

On June 24, the U.S. Food and Drug Administration (FDA) published import alerts for certain medical devices manufactured at the company’s Aizu facility in Fukushima, Japan. This action prevents the import of the specified devices into the U.S. until further notice. The devices affected include certain bronchoscopes, laparoscopes, ureterorenoscopes, and automated endoscope reprocessors.

Olympus is committed to addressing the FDA’s concerns promptly and ensuring that our products meet the highest quality standards. Our highest priority is providing our customers with safe and effective solutions for patient care.

For reference, the revenue generated by these devices in the U.S. accounted for approximately 1% of Olympus’ consolidated revenue for the fiscal year ended March 2025. It is important to note that at this stage, and based on our initial evaluation, this action does not impact the import of these devices into any other countries globally.

Please refer to the FDA alerts for full scope information: Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers | FDA