Olympus Corporation of the Americas
Device Recalls (Class II)
Class II
Z-1612-2026
·
20260401
·
Ongoing
Product
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Reason for Recall
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API