Olympus BF-H1100 bronchovideoscopes sold nationwide in the US were recalled. The recall updates the IFU to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Stop using the device immediately and follow the manufacturer’s 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 flexible endoscopes used during bronchoscopy to examine the airways and airways passages.
The updated IFU provides guidance on safe and effective use when used with laser, APC, and high-frequency therapy equipment.
This recall is not part of a broader industry pattern.
Healthcare facilities should review the updated IFU guidance and ensure staff are trained on compatible equipment use.
Label on device, packaging, IFU, and FDA recall page.
4-8 weeks for remedy processing if applicable; follow manufacturer instructions in the meantime.
Keep recall notices, device labels, UDI, and all correspondence.
Model No.: BF-H1100; UDI: 4953170424229; Serial numbers: All Serial No.; Sold at: US nationwide distribution; 1,867 units overseas; Recall date: 2025-09-11; Status: Active
No injuries or incidents have been reported.
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