Olympus Corporation of the Americas recalled 4,289 bronchofiberscopes on September 11, 2025. The recall addresses important updates to the instructions for use when combined with specific medical equipment. Healthcare providers and patients must stop using the 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
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The recall affects the Bronchofiberscope Olympus BF Type PE2. It includes model number BF-PE2 and the unique device identifier UDI: 4953170339974. The devices distributed nationwide in the U.S. have an unknown price.
The recall pertains to additional instructions for safe and effective use of bronchoscopes when used with laser, argon plasma coagulation, and high-frequency therapy equipment. The classification of this recall is Class I, indicating a high risk to patient safety.
No specific incidents or injuries related to the use of the bronchofiberscope have been reported, but the potential risks warrant immediate action.
Patients and healthcare providers must stop using the Bronchofiberscope Olympus BF Type PE2 immediately. They should follow the recall instructions provided by the manufacturer and contact Olympus Corporation of the Americas for further guidance.
For further inquiries, contact Olympus Corporation of the Americas. Visit the FDA website for more information on the recall.
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