Olympus Shares Plunge After FDA Quality Warning

Olympus Corporation shares dropped 12.92% to a 12-week low of 1,770 yen on Tuesday following the disclosure of a warning letter from the U.S. Food and Drug Administration. The FDA issued the warning on October 7 after conducting inspections of company facilities in Japan, the United States, and Europe in late 2025.

The regulatory agency cited concerns regarding the medical-device maker's quality management system and associated procedures. Olympus stated that the warning does not block new 510(k) clearances, require product recalls, or restrict the company's ability to manufacture, market, and distribute its products.

The company maintains that its products remain safe and effective for use. Olympus plans to submit a detailed response to the FDA within 15 business days and is launching a multi-year program to strengthen its global quality systems.