FDAHealthMarch 25, 2026

Olympus Corporation of the Americas — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

⚠️ 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-2112
Brand: Olympus Corporation of the Americas
Lot code: 09A

Additional details

Model Number: MAJ-2112. UDI Number: 04953170404078. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 21A, 22A, 23A, 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.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 8,994 units.

View original FDA notice →

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