Olympus Corporation of the Americas recalled 116 units of the BF Type XT40 bronchoscope on September 11, 2025. The recall addresses safety concerns regarding the device's use with laser and high-frequency therapy equipment. Healthcare providers must halt use immediately and follow specific instructions from Olympus.
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 OES Bronchoscope Olympus BF Type XT40, with all serial numbers affected. It was distributed nationwide in the U.S. and is classified as a Class I medical device.
The recall addresses the need for updated instructions for safe use of the bronchoscope with laser and argon plasma coagulation equipment. Misuse can result in serious complications during medical procedures.
No specific incidents or injuries have been reported as a result of this issue. However, the potential for serious injury exists if the device is used incorrectly.
Stop using the bronchoscope immediately. Follow the recall instructions provided by Olympus Corporation of the Americas or consult your healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas at their official website or through the recall notice linked here: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0067-2026.
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