Olympus Corporation of the Americas recalls 5,221 units sold in the U.S. and 4,321 units overseas. The recall covers the EVIS EXERA III BRONCHOVIDEOSCOPE BF-H190. It flags updated instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow 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-H190 is a bronchoscope used in diagnostic and therapeutic airway procedures. It may be used with laser, argon plasma coagulation and high-frequency therapy equipment during complex interventions.
The recall addresses updated IFU guidance. The risk relates to safe and effective use during procedures that involve energy-based devices.
This recall is not part of a broader industry pattern identified in the provided data.
Medical professionals must verify guidance before procedures. The recall may affect scheduling of procedures and replacement parts. There is potential for delays in care if guidance is not followed.
UDI plate and device labeling contain the UDI; manufacturer guidance documents contain the IFU update details
Refunds or replacements are handled per Olympus guidance; exact timeline not provided
Keep recall notice, communication with Olympus, and any replacement IFU materials
Product: EVIS EXERA III BRONCHOVIDEOSCOPE BF-H190. Brand: Olympus Corporation of the Americas. Model: BF-H190. UDI: 4953170335174. Serial numbers: All serial numbers affected. Units recalled: 5,221 in the United States; 4,321 outside the United States. Distribution: US nationwide.
No specific injuries or incidents are reported in the provided data.
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