Olympus Corporation of the Americas confirms a Class I recall of the BRONCHOFIBERSCOPE BF TYPE PE2. The recall covers 2 units in the US and 4,289 units outside the US. Updated IFU guidance aims to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
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 medical devices used to visualize and sample airways. They may be used in procedures that involve laser or energy-based devices.
The updated IFU aims to prevent misuse during procedures that involve laser, argon plasma coagulation, and high-frequency devices by clarifying safe and effective use.
This recall is not part of a broader industry pattern.
The recall could delay procedures unless mitigated by updated instructions and clear usage guidance.
FDA recall page linked in notice; Olympus customer support
Remedies and replacement instructions will be issued by Olympus; expect communication within weeks
Keep the recall notice, purchase records, serial numbers, and all correspondence with Olympus
Brand: Olympus Corporation of the Americas. Product: BRONCHOFIBERSCOPE BF TYPE PE2. Model No.: BF-PE2. UDI: 4953170339974. Serial numbers: All serial numbers. Sold/distributed: US nationwide and international distribution. Recall date: 2025-09-11. Status: ACTIVE.
No specific incidents or injuries are cited in the recall notice. The hazard level is listed as HIGH due to potential misuse if IFU are not followed.
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