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OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

Class II
Recalling firm
Olympus Corporation of the Americas
Reason for recall
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Affected products (lot / model / serial)
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.
Units affected
373 units
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
Firm location
Center Valley, PA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-1904-2026
Recall initiated
March 25, 2026
FDA classification date
April 22, 2026
FDA report date
April 29, 2026
FDA event ID
98544
Last updated on HTM Vibe
July 24, 2026
View on openFDA