Recall Z-1911-2025— Olympus Corporation of the Americas

Name: FDA recall Z-1911-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-05

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-05-05. It names one FDA 510(k) clearance: K220587. Product: Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V. Reason: Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2025-05-05
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K220587 — Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.·cleared 2022-05-11

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 EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V

Reason for recall

Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.

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