Olympus Corporation of the Americas recalls the BF-TE2 bronchofiberscope distributed nationwide in the United States. The recall updates the Instructions for Use to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Stop using the device immediately and follow the manufacturer’s recall 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 BF-TE2 bronchofiberscope is a flexible endoscope used for bronchoscopy to visualize airways. It is designed for procedures potentially used alongside laser, APC and high-frequency therapy equipment.
The recall updates the IFU to clarify safe and effective use with adjacent equipment. Misuse may lead to harm during procedures that involve lasers or energy devices.
This recall is not part of a broader industry pattern.
Hospitals and clinics must review the updated IFU, train staff, and halt use of affected devices until guidance is followed. Consumers may experience procedural delays while guidance is updated.
Recall notices on FDA enforcement page and Olympus website; device label may reference updated IFU.
No specific timeline published for refunds or replacements. Follow manufacturer instructions. Resolution timelines for medical device recalls vary by
Keep a copy of the recall notice, correspondence with the manufacturer, and records of any device use involving lasers or energy devices.
Model No.: BF-TE2. UDI: 4953170339998. All Serial No. units affected. Sold in the United States and internationally. Quantity: 1 unit US; 5,286 units outside the US. Distribution: US Nationwide Distribution. Price: Unknown.
No injuries or incidents have been reported.
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