Recalling firm
Olympus Corporation of the Americas
Product type
Device
Status
Ongoing
Report date
2026-04-01
Distribution
US Nationwide distribution.
Firm state
PA
Product quantity
2,929 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Product description
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Code / lot info
Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.