Olympus Corporation of the Americas recalled 5,221 units of the EVIS EXERA III Bronchoscope BF-H190 on September 11, 2025. The recall aims to address safety concerns when used with laser and high-frequency therapy equipment. Healthcare providers and patients must stop using the device immediately.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions
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The recalled product is the EVIS EXERA III Bronchoscope, model BF-H190. It was distributed nationwide in the U.S. and internationally with a total of 9,542 units. The device's unique device identifier (UDI) is 4953170335174.
This recall addresses updates to the Instructions for Use (IFU) for the bronchoscope. The updates clarify safe and effective use in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. The hazard level of this recall is classified as high.
No specific incidents of injury or death have been reported related to this recall. The manufacturer emphasizes the importance of adhering to the updated IFUs to avoid potential risks.
Patients and healthcare providers should immediately stop using the EVIS EXERA III Bronchoscope. Follow the recall instructions provided by Olympus Corporation of the Americas. Contact your healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas. Visit their website at www.olympus-global.com or call their customer service line.
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