Olympus Corporation of the Americas recalled 3,046 units of its EVIS EXERA III bronchoscope BF-P190 on September 11, 2025. The recall addresses safety concerns regarding the use of the bronchoscope with laser and high-frequency therapy equipment. Healthcare providers must stop using this device immediately.
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
The recall involves the EVIS EXERA III bronchoscope, model BF-P190. It was distributed nationwide in the United States and includes 3,046 units. No pricing information is available.
The recall was initiated due to additional instructions for use (IFU) updates needed for safe and effective use with laser and argon plasma coagulation equipment. This situation poses a high hazard level.
As of now, there are no reported incidents or injuries related to this recall. The device's classification is Class I, indicating a high risk.
Patients and healthcare providers should stop using the bronchoscope immediately. Follow the recall instructions provided by Olympus Corporation or contact your healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas. Visit their website at www.olympus.com or call their customer service.
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