Olympus Corporation Of The Americas: Duodenoscope And Accessories, Flexible/rigid
Olympus Corporation is recalling its Single Use Distal Cover (model MAJ-2315), a protective cover used with certain duodenoscopes during medical procedures, because a newly designed version has been developed to replace the previous design. The recall affects the earlier version of this cover that was distributed nationwide across all U.S. states.
- Recalling firm
- Olympus Corporation of the Americas
- 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
- Reason
- Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-05
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a8b48f97-450b-4244-bdf7-f32e0db9800d