Recall Z-0379-2022— Olympus Corporation of the Americas

Name: FDA recall Z-0379-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-02

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2021-11-02. It names one FDA 510(k) clearance: K143153. Product: EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V. Reason: Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2021-11-02
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K143153 — EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180VOlympus Medical Systems Corp.·cleared 2016-01-15

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

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Reason for recall

Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

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