Home / Recalls / Olympus Corporation of the Americas / Z-1613-2023

Z-1613-2023 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
May 31, 2023
Initiation Date
April 18, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
309278 pieces

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.

Distribution Pattern

US Nationwide.

Code Information

UDI-DI: 04953170403019; Item code: Catalog N5786100 Lots Lower than H2530

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