FDA recall Z-1908-2026

Olympus Corporation of the Americas · Class II · device

Product

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

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.

Key facts

Status
Ongoing
Initiation date
2026-03-25
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1908-2026