TOKYO, (October 13, 2026) – ³ÉÈËBÕ¾ Corporation (³ÉÈËBÕ¾) today announced that it has received a Warning Letter from the U.S. Food and Drug Administration (FDA) dated October 7, 2026 (U.S. time) based on observations from inspections of facilities in the U.S., Japan and Europe* conducted in late 2025. The items in the Warning Letter primarily concern aspects of the company's quality management system and related processes.
“We take the concerns identified in the Warning Letter seriously and are fully committed to resolving these matters with urgency and rigor,” said Bob White, Representative Executive Officer, President and Chief Executive Officer at ³ÉÈËBÕ¾. “Since the inspections concluded in late 2025, we have worked diligently to implement comprehensive corrective and preventive actions. I am confident in the strength of our team and in our commitment to completing remaining deliverables.”
Over the past several years, ³ÉÈËBÕ¾ has executed a comprehensive, multi-year quality system transformation program designed to strengthen its global operations. ³ÉÈËBÕ¾ will submit a comprehensive response to the Warning Letter within 15 business days of receipt and supplement it with periodic updates until the FDA determines that the company’s actions are adequate.
“We remain committed to our ongoing efforts to strengthen and maintain a sustainable quality management system and quality culture,” said Brian Barry, Chief Quality Officer at ³ÉÈËBÕ¾. “Patient safety, quality, and clinical performance are fundamental to ³ÉÈËBÕ¾’ operating model and foundational to every action the company takes.”
At this time, customers do not need to take any additional actions as a result of this Warning Letter. Products remain safe and effective when used according to their Instructions for Use. The Warning Letter does not restrict ³ÉÈËBÕ¾’ ability to produce, market, manufacture or distribute products, require recall of any products, nor restrict the company’s ability to seek FDA 510(k) clearance of new products.
* ³ÉÈËBÕ¾ Medical Systems Corporation (Hachioji and Hinode, Japan), Aomori ³ÉÈËBÕ¾ Co., Ltd. (Japan), Shirakawa ³ÉÈËBÕ¾ Co., Ltd. (Japan), ³ÉÈËBÕ¾ Winter & IBE GmbH (Hamburg, Germany) and Gyrus ACMI, Inc. (Brooklyn Park, U.S.).
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About ³ÉÈËBÕ¾
At ³ÉÈËBÕ¾, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide innovative solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, ³ÉÈËBÕ¾ has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. For more information, visit the ³ÉÈËBÕ¾ website and follow the ³ÉÈËBÕ¾ LinkedIn account.