—#218481

Product

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

FDA product code: FEB — Accessories, Cleaning, For Endoscope
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K201920
Affected lot / code info: Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.

Why it was recalled

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Root cause (FDA determination)

Reprocessing Controls

Action the firm took

Olympus notified consignees on about 02/12/2026 via URGENT: MEDICAL DEVICE CORRECTION letter. Consignees were instructed to immediately cease reprocessing the MAJ-1443 and MAJ-1444 valves in an OER-Pro or OER-Elite and ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the full extent of the MAJ-1443 and MAJ-1444 reprocessing steps as detailed in the provided Instructions for Use (IFU). The updated IFU can also be accessed electronically through OlympusConnect.com. Additionally, consignees were instructed to replace any existing copies of the MAJ-1443/MAJ-1444 IFU with the updated IFU provided in this letter, identify and notify all customers if affected units were further distributed and complete and confirm receipt of the notification via the Olympus web portal.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2026-02-12
Posted by FDA: 2026-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218481. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.