Z-1904-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- March 25, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 373 units
Product Description
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Reason for Recall
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
Code Information
Model: MAJ-2116. UDI Number: 04953170404115. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 25A, 26A, 27A, 28A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 51A.