Class I

Medical Device Recall: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

Olympus Corporation of the Americas · September 11, 2025

Reason for Recall

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.

Distribution

US Nationwide Distribution.

States Affected

NATIONWIDE

Quantity Affected

5,221 units US; 4,321 units OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0053-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.