PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: December 22, 2021 Initiated: November 2, 2021 #Z-0379-2022

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.

Details

Units Affected
14,447 units
Distribution
US Nationwide distribution.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V. Recalled by Olympus Corporation of the Americas. Units affected: 14,447 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 22, 2021. Severity: Moderate. Recall number: Z-0379-2022.