FDAHealthFebruary 12, 2026
Olympus Corporation of the Americas — Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
⚠️ The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 12, 2026
US Nationwide distribution.
What's affected?
- Product
- Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
- Lot code
- /Serial
Additional details
Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2,929 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.