Recalling firm
Olympus Corporation of the Americas
Product type
Device
Status
Ongoing
Report date
2026-07-15
Distribution
US Nationwide distribution.
Firm state
PA
Product quantity
988700 units
Initiated by
Voluntary: Firm initiated
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.
Product description
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
Code / lot info
UDI/DI: 04953170441271, Lot Numbers: H2530 or later
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.