Recall Z-0052-2026— Olympus Corporation of the Americas

Name: FDA recall Z-0052-2026
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: K250862. Product: BRONCHOVIDEOSCOPE OLYMPUS BF-H1100. 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

K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190) +4 moreOlympus Medical Systems Corp.·cleared 2025-06-23

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

BRONCHOVIDEOSCOPE OLYMPUS BF-H1100

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.