Recall Z-1613-2023— Olympus Corporation of the Americas

Name: FDA recall Z-1613-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-18

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-04-18. It names one FDA 510(k) clearance: K193182. Product: Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100. Reason: The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-04-18
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K193182 — Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.·cleared 2020-01-17

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 Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

Reason for recall

The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.

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