Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid

Class II

Recalling firm: Olympus Corporation of the Americas
Reason for recall: Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Affected products (lot / model / serial): UDI/DI: 04953170441271, Lot Numbers: H2530 or later
Units affected: 988700 units
Distribution pattern: US Nationwide distribution.
Firm location: Center Valley, PA, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-2676-2026
Recall initiated: June 5, 2026
FDA classification date: July 7, 2026
FDA report date: July 15, 2026
FDA event ID: 99106
Last updated on HTM Vibe: July 23, 2026