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Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

Class II
Recalling firm
Olympus Corporation of the Americas
Reason for recall
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Affected products (lot / model / serial)
Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
Units affected
2,929 units
Distribution pattern
US Nationwide distribution.
Firm location
Center Valley, PA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-1612-2026
Recall initiated
February 12, 2026
FDA classification date
March 20, 2026
FDA report date
April 1, 2026
FDA event ID
98371
Last updated on HTM Vibe
July 24, 2026
View on openFDA