Olympus announced recently that it is committed to addressing the concerns of the FDA around its device manufacturing in Japan.
Last week, the FDA notified healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus and its subsidiaries.
According to the notice, the FDA has “concerns related to outstanding quality system regulation violations by Olympus.” The agency cites “extensive and ongoing efforts to address compliance issues” with the company as well. As a result, it issued import alerts to prevent future shipments of certain devices manufactured in Japan from entering the U.S.
Devices included in the warning are ureterorenoscopes, bronchoscopes, laparoscopes and automated endoscope reprocessors.
On June 27, Olympus responded to the FDA notice with a statement in a news release:
“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.”
The company also notes that the revenue generated by the affected 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,” the company said.
Olympus stock recovered somewhat on the Tokyo Stock Exchange today, although the price per share remains down more than 10% over the past five trading days.
