Medical device recalls High risk

Olympus Corporation of the Americas recalls BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100

Recall date
September 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0048-2026
FDA classification
Class I
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
US Nationwide Distribution.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100

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