Olympus Corporation of the Americas recalled 1,473 EVIS EXERA II Bronchoscopes on September 11, 2025. The recall addresses critical updates to the instructions for use when combined with laser and coagulation therapies. Healthcare professionals must stop using the device immediately and follow the manufacturer's instructions.
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 II Bronchoscope, model BF-1T180. The recall impacts 1,473 units distributed in the U.S. and 3,774 units internationally. The product has no specified retail price.
The recall addresses additional instructions for safe use of the bronchoscope when used with laser and high-frequency therapy equipment. Improper usage may lead to serious risks during medical procedures, necessitating immediate cessation of use.
No specific incidents or injuries have been reported in relation to this recall. However, the classification as Class I indicates a high potential risk associated with the device.
Patients and healthcare providers must stop using the bronchoscope immediately. Contact Olympus Corporation of the Americas or your healthcare provider for detailed instructions regarding the recall.
For more information, contact Olympus Corporation of the Americas. Visit their website or call their customer service for assistance.
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