Olympus Corporation of the Americas: Device Recall

Recall #Z-0049-2026 · 09/11/2025

Class I: Dangerous

Recall Details

Recall Number: Z-0049-2026
Classification: Class I
Product Type: Device
Recalling Firm: Olympus Corporation of the Americas
Status: Ongoing
Date Initiated: 09/11/2025
Location: Center Valley, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,297 units US; 4,290 units OUS

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.

Product Description

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190

Distribution Pattern

US Nationwide Distribution.

Other Recalls by Olympus Corporation of the Americas

Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.