Olympus Corporation of the Americas issued a Class I recall for 821 BF-XT40 bronchoscopes worldwide, including 116 units in the United States and 705 outside the U.S. The recall centers on updated Instructions For Use to clarify safe and effective use with laser, argon plasma coagulation and high-frequency therapy equipment. Hospitals and clinics should stop using the devices and follow Olympus’召v
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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Bronchoscopes are flexible endoscopes used to visualize the airways. The BF-XT40 is an Olympus model used in diagnostic and therapeutic procedures.
The recall updates IFU to clarify safe use when combined with laser, APC and high-frequency therapy equipment, aiming to prevent procedural misuse.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics should review updated IFU and training materials. Immediate action is required to stop use until guidance is applied.
IFU updates and recall notices available from Olympus and FDA enforcement pages
Not specified in the recall. Follow Olympus instructions and FDA updates for remediation timelines
Keep recall notice, update IFU documents, training records, and incident reports for compliance and audits
Model No.: BF-XT40. Distribution: US nationwide distribution; 705 units outside the US. When sold and price not provided. Serial numbers: All serial numbers affected.
No injuries or incidents have been reported.
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