Olympus Corporation of the Americas recalled 262 EVIS EXERA bronchoscopes on September 11, 2025. The recall addresses safety issues related to the use of bronchoscopes with laser and coagulation equipment. Healthcare providers and patients must stop using the devices immediately for safety reasons.
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 Bronchoscope, model BF-XT160, UDI 4953170340147. A total of 262 units were distributed in the United States and 558 units outside the U.S. The devices were distributed nationwide.
The recall addresses the need for additional instructions for safe use of bronchoscopes when combined with laser and high-frequency therapy equipment. Misuse may lead to serious complications during procedures.
There have been no reported injuries or deaths related to this recall. However, the classification of the recall as Class I indicates a high hazard level.
Stop using the bronchoscope immediately. 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 official website or call customer service for assistance.
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