Z-1901-2026 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
- 8,936 units
Product Description
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
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 Number: MAJ-2113. UDI Number: 04953170404085. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.