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Recall Observatory FDA recall evidence

Device product

BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

Z-0064-2026

September 11, 2025

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 97441
Status
Ongoing
Classification
Class I
Quantity
1 unit US; 5,286 units OUS
Official record key
device-enforcement:Z-0064-2026

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-TE2; UDI: 4953170339998; 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.