Olympus recalled 6,450 BF-P60 bronchofiberscopes worldwide after updated instructions clarify safe use with laser, argon plasma coagulation and high-frequency therapy devices. The recall covers 1,007 US units and 5,443 units outside the US. Healthcare providers should stop using the device immediately and follow manufacturer instructions. Contact Olympus Corporation of the Americas for guidance.
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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Bronchofiberscopes are flexible endoscopes used to examine the airways and assist in airway-related procedures.
The recall updates safety guidance to ensure proper use with laser, APC and high-frequency therapy equipment to prevent misuse and potential patient harm.
This recall is not stated as part of a broader industry pattern.
Hospitals and clinicians should implement updated IFU guidance. Workflow changes may be needed, and there could be delays in device availability during transition.
FDA enforcement page for Z-0058-2026 and the manufacturer’s recall notices
Remediation timelines vary by institution; anticipate several weeks for approvals and implementation
Keep the recall notice, UDI, model BF-P60 documentation, and all correspondence with the manufacturer. Document staff training and protocol updates.
Model No.: BF-P60 UDI: 4953170339196 Sold in: US nationwide; international (OUS) Quantity recalled: 1,007 US units; 5,443 OUS units; total 6,450 Price: Unknown Recall date: 2025-09-11 Status: ACTIVE Manufacturer: Olympus Corporation of the Americas Additional notes: All serial numbers affected
No injuries or incidents have been reported.
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