FDAFDA · Food and drugs·Recall number Z-2676-2026
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
Published July 15, 2026 · Recall initiated: June 5, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide distribution.
- Lot
- UDI/DI: 04953170441271, Lot Numbers: H2530 or later
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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