Z-2676-2026 Class II Ongoing
FDA device recall Z-2676-2026 was initiated by Olympus Corporation of the Americas on June 5, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 988700 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2026
- Initiation Date
- June 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 988700 units
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
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI: 04953170441271, Lot Numbers: H2530 or later