Olympus Corporation has been hit with a warning letter from the US Food and Drug Administration (FDA) following inspections at its international manufacturing sites, prompting the Japanese conglomerate’s share price to plummet.
Olympus received the warning letter on 7 October, though it publicly revealed receipt on 13 October, following inspections at six of its manufacturing sites across the US, Japan, and Europe in late 2025. The FDA found deficiencies in the company’s quality management system and related processes.
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The disclosure prompted Olympus’ shares, listed on the Tokyo Stock Exchange, to fall by approximately 13% at market open on 14 October to around Y1,780 ($11.28) per share, down from around Y2,000 previously. Olympus, whose presence in the healthcare space is spearheaded by its endoscopy portfolio and diagnostic offerings, has a market cap of Y1.9trn.
The breadth of the deficiencies was not immediately clear, given that the letter has not yet been entered into the relevant FDA database. Medical Device Network has reached out to Olympus for more information.
In a statement regarding the FDA’s letter, Bob White, Olympus’ president and CEO, said: “We take the concerns identified in the warning letter seriously and are fully committed to resolving these matters with urgency and rigour.
“Since the inspections concluded in late 2025, we have worked diligently to implement comprehensive corrective and preventive actions,” White added, stating that the company is committed to completing remaining deliverables.
To remediate the failings uncovered by FDA inspectors, Olympus has pledged to submit a “comprehensive response” to the warning letter within 15 business days of receipt and to supplement it with “periodic updates” until the FDA “determines that the company’s actions are adequate”.
Brian Barry, chief quality officer at Olympus, commented: “We remain committed to our ongoing efforts to strengthen and maintain a sustainable quality management system and quality culture.
“Patient safety, quality, and clinical performance are fundamental to Olympus’ operating model and foundational to every action the company takes.”
In the healthcare space, Olympus’ main presence is in the endoscopy market, while the company also manufactures diagnostic accessories such as sampling needles and related airway intervention tools. GlobalData analysis projects that the endoscopy market is growing at a compound annual growth rate (CAGR) of 6.4% and is on course to reach a valuation of around $38.3bn in 2035.
According to GlobalData market models, Olympus held a leading US market share within several sub-sectors of the endoscope market in 2025, including a 45.9% and 51.5% share of the US gastroscope and duodenoscope markets, respectively.
Latest Warning Letter adds to Olympus’ quality management woes
This is not the first time Olympus has fallen short of FDA expectations in recent years. Olympus’ endoscope line was put under a Class I recall in December 2023 following reports of a patient death and several injuries linked to endobronchial burns following the use of the company’s bronchoscopes. In 2024, the company experienced issues as one of its endoscope components was linked to a patient death and 120 injuries.
Due to separate quality concerns in June 2025, the FDA blocked certain bronchoscope, laparoscope, and ureterorenoscopes manufactured by Olympus in Japan from entering the US.
These ongoing quality-related challenges have resulted in intense pressure being placed on White to turn Olympus’ fortunes around since taking on the role of CEO in June 2025, after former CEO Stefan Kaufmann was forced to leave the company in October 2024 after being accused of purchasing illicit drugs.
To shrug off its recent controversies, Olympus outlined plans to restructure its endoscopy business in November 2025. The plan involves laying off 2,000 staff across Olympus’ global workforce, with the move intended to simplify business operations — an action Olympus said would allow for clearer accountability within its endoscopy operations.
