Recall Z-0064-2026— Olympus Corporation of the Americas

Name: FDA recall Z-0064-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-11

Class I · Ongoing

Class I FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-09-11. It names one FDA 510(k) clearance: K023984. Product: BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2. 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class I
Status: Ongoing
Initiated: 2025-09-11
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESThe Olympus Optical Co.·cleared 2003-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.