Olympus recalls 3,046 BF-P190 bronchovideoscopes sold nationwide in the US and 2,414 overseas. The recall centers on updated IFU guidance to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Clinicians and facilities should stop using the device immediately and follow Olympus 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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Bronchovideoscopes are used by respiratory specialists to visualize airways during bronchoscopy. They are part of diagnostic and therapeutic procedures.
The issue relates to updated IFU clarity for safe and effective use with laser, APC, and high-frequency therapy equipment, which could affect procedural safety if misapplied.
This recall is not described as part of a broader industry pattern.
Clinicians must verify guidance before use. Delay in proper instruction could impact patient safety during complex endoscopic therapies.
FDA recall page for Z-0057-2026 and Olympus recall communications
Remedies and instructions will be issued by Olympus through the recall process; no specific timeline provided
Retain recall notices, model/UDI, serial numbers, correspondence with Olympus, and any replacement or refund documents
Model BF-P190 UDI 4953170342110 All Serial Numbers affected Quantity recalled: 3,046 US units; 2,414 outside US Sold/distributed: US nationwide; worldwide distribution Recall date: 2025-09-11 Status: ACTIVE Brand: Olympus Corporation of the Americas Category: Health & Personal Care, Medical Devices
No injuries or incidents have been reported.
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