Olympus Corporation of the Americas recalls 361 units in the US and 258 units overseas as of September 11, 2025. The recall targets the EVIS EXERA b Bronchovideoscope BF-XT190. The update adds safety instructions for using bronchoscopes with laser, argon plasma coagulation, and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow a
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-XT190 bronchovideoscope is used in bronchoscopy procedures to visualize airways. It is involved in procedures using adjunctive laser, APC, or high-frequency therapy equipment.
IFU updates clarify safe and effective use when combined with certain energy devices. Misuse could lead to procedural complications.
This recall is not part of a broader industry pattern at this time.
Clinicians may need to pause procedures involving the BF-XT190 while awaiting updated instructions.
Official recall notices and FDA enforcement page Z-0066-2026
Remedies and guidance will be communicated by Olympus; timeline will vary by facility.
Keep recall notices, purchase records, serial numbers, and all correspondence with Olympus.
Brand: Olympus Corporation of the Americas. Product: EVIS EXERA b Bronchovideoscope BF-XT190. Model No.: BF-XT190. UDI: 4953170402470. Serial numbers: All serial numbers affected. Units recalled: 361 in the US; 258 overseas. Distribution: US nationwide.
No injuries or incidents have been reported in the recall notice. The hazard level is classified as HIGH due to potential misapplication risks.
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