FDAHealthJune 5, 2026

Olympus Corporation of the Americas — Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideosc

⚠️ Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: June 5, 2026

US Nationwide distribution.

What's affected?

Product: 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
Brand: Olympus Corporation of the Americas
Lot code: H2530

Additional details

UDI/DI: 04953170441271, Lot Numbers: H2530 or later

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 988700 units.

View original FDA notice →

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