Recall Z-1132-2023— Olympus Corporation of the Americas

Name: FDA recall Z-1132-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-21

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2022-12-21. It names one FDA 510(k) clearance: K100584. Product: EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL. Reason: A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2022-12-21
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K100584 — EVIS EXERAII 180 SYSTEMOlympus Medical Systems Corporation·cleared 2010-07-02

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 III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL

Reason for recall

A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

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