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Recall Observatory FDA recall evidence

Device product

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190

Z-0049-2026

September 11, 2025

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 97441
Status
Ongoing
Classification
Class I
Quantity
4,297 units US; 4,290 units OUS
Official record key
device-enforcement:Z-0049-2026

Official wording

Reason: 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.

Code information: Model No. BF-1TH190; UDI: 4953170434778; All Serial No.

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.