TOYKO – The U.S. Food and Drug Administration (FDA) has issued an import alert for certain medical devices made by Olympus.
Olympus is based in Tokyo, Japan, but the company’s North American headquarters have been in Upper Saucon Township, Lehigh County since 2006.
“Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the FDA wrote.
The agency’s alert prevents future shipments of certain products from entering the U.S., including specific models of ureterorenoscopes, bronchoscopes, laparoscopes and enteroscopes.
The alert follows a warning letter issued to the company earlier this month, based on FDA inspections of facilities in the U.S., Japan and Europe in June 2025.
According to the FDA’s website, warning letters are issued after inspections identify concerns, such as “poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.”
Olympus acknowledged receipt of the letter. The company said in a news release it is taking the FDA’s concerns seriously and is committed to resolving the issues with “urgency and rigor.”
In a separate news release issued Wednesday, following the FDA’s announcement of the import alert, Olympus said it is “committed to ensuring that its products meet the highest quality standards and supporting the customers and healthcare professionals who depend on them.”
The company also pledged to work “transparently and constructively” with the FDA.
The import alert involves three manufacturing sites in Japan. It only impacts products being shipped to the U.S.; other countries can still receive them.
The FDA has taken several actions related to quality system requirements and compliance concerns with Olympus in recent years. Records show the agency previously issued several warning letters to the company or its subsidiaries in 2022 and 2023.
An import alert for certain devices made at the company’s Aizu facility in Fukushima, Japan, was issued last year.
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