Olympus Shares Plunge Up to 17% After FDA Warning Letter Targets Six Facilities

Olympus Corp. shares slumped as much as 17% in Tokyo—their steepest drop since April 2025—after the US Food and Drug Administration issued a warning letter regarding six of the Japanese medical device maker's facilities. In a Tuesday filing, Olympus stated that the FDA letter stems from quality management system and process observations recorded during inspections conducted in late 2025. The company said the warning will not disrupt production and is not expected to impact its financial results, adding that it is set to respond within 15 business days of receiving the letter. Jefferies Japan Ltd. analysts Stephen Barker and Miyabi Yamakita noted that investors had hoped the FDA had accepted Olympus's corrective actions since nearly a year had elapsed since the late 2025 inspections. The analysts wrote that the warning follows an earlier regulatory hit in June 2025, when Olympus shares sank as much as 12% after the FDA alerted healthcare providers that certain Japan-manufactured devices from an Olympus unit faced import alerts. "The letter is not entirely unexpected, but it disappoints... The new letter confirms that Olympus's quality issues are systemic." — Stephen Barker and Miyabi Yamakita, Jefferies Japan Ltd. analysts.