Japanese medical device maker Olympus experienced its largest one-day share price decline in 15 years following a fresh warning from the US Food and Drug Administration (FDA) regarding ongoing compliance concerns. On Monday, the company’s shares dropped 13.5 percent during trading in Tokyo, with intraday losses reaching as much as 16.5 percent. This marks the steepest single-day fall since Olympus revealed an accounting scandal in 2011.

The $12.4 billion medical technology group, a leading supplier of medical endoscopes—thin tubes used for non-surgical internal examinations—has faced FDA scrutiny over manufacturing quality issues since 2022. The US regulator has banned the import of certain Olympus devices due to concerns about production standards, and the latest warning letter specifically criticized the company’s quality management system. This action came after inspections at six of Olympus’s factories across the United States, Japan, and Europe toward the end of 2025 identified ongoing problems.

Olympus Chief Executive Bob White stated that the company takes the FDA’s concerns seriously and is fully committed to addressing the issues with urgency and thoroughness. The firm has pledged to submit a comprehensive response to the FDA within 15 business days. Founded over a century ago, Olympus has sought to distance itself from recent difficulties through structural reforms.

Earlier this year, White detailed efforts akin to private equity strategies to counter potential takeover attempts. These measures have included reducing the workforce by approximately 2,000 positions, restructuring regional operations, and divesting non-core assets to streamline the business. Despite a rebound in share value after a sharp decline in February tied to a weaker profit forecast, Olympus’s stock remains down 13.5 percent year-to-date.

The latest FDA warning has heightened speculation that Olympus is increasingly vulnerable to bids from private equity firms and industry competitors. Industry analysts view the persistent quality issues as systemic and unlikely to be resolved quickly. Stephen Barker, an analyst at Jefferies, noted that with more manufacturing sites now under regulatory warning, full remediation may take several years rather than months.

Sources familiar with Olympus’s turnaround efforts indicate that private equity investors remain closely watchful of the company’s progress under White’s leadership. The continuing regulatory challenges underscore the complex compliance environment facing medical device manufacturers operating in multiple jurisdictions.