Recall Z-2498-2023— Olympus Corporation of the Americas

Name: FDA recall Z-2498-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-27

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-07-27. It names one FDA 510(k) clearance: K183419. Product: Olympus Bronchovideoscope, Models BF-XT190.. Reason: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-07-27
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K183419 — EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp.·cleared 2019-09-05

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

Olympus Bronchovideoscope, Models BF-XT190.

Reason for recall

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

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