TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
UDI/DI: 04953170441271, Lot Numbers: H2530 or later
- Why
- Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
- Distributed
- US Nationwide distribution.
- Company
- Olympus Corporation of the Americas
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2676-2026 · retrieved 7 July 2026
Read the official notice