Olympus Corporation recalled 4,297 EVIS EXERA III bronchoscopes on September 11, 2025. The recall follows updates to the instructions for use regarding safe operation 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
The recalled product is the EVIS EXERA III Bronchoscope, Model No. BF-1TH190. It has a Unique Device Identifier (UDI) of 4953170434778. The devices were distributed across the United States.
The recall addresses additional instructions for safe and effective use of bronchoscopes in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. Improper use may lead to significant safety risks.
No specific incidents or injuries have been reported in connection with this recall. The classification is Class I, indicating a high level of hazard.
Stop using the bronchoscope immediately. Follow the recall instructions provided by Olympus Corporation and consult your healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas. Visit the FDA's recall page or call your healthcare provider.
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