Olympus says it will act swiftly to address FDA concerns over quality system regulation violations at its Japan-based manufacturing facilities. The agency recently issued import alerts that block certain Olympus devices—such as ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors—from entering the U.S.
The FDA cited “extensive and ongoing” compliance issues, prompting this latest action to protect patient safety. Olympus responded on June 27, affirming that ensuring product quality remains its “highest priority” and pledging to correct deficiencies promptly.
The company emphasized that the affected devices represent about 1% of Olympus’ total revenue for FY2025 and that other international markets remain unaffected. Despite the setback, Olympus shares partially rebounded in Tokyo today but remain down over 10% in the past week.
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