Olympus Corporation of the Americas: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

Hazard

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Details from the source

Reason for recall: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. Quantity: 373 units Lot/code info: 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.

UPC codes

04953170404115

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.