FDAHealthMarch 25, 2026
Olympus Corporation of the Americas — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
⚠️ Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 25, 2026
Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
What's affected?
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
- Lot code
- 09A
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 373 units.
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