Recall Z-1612-2026— Olympus Corporation of the Americas

Name: FDA recall Z-1612-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-12

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2026-02-12. It names one FDA 510(k) clearance: K201920. Product: Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.. Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2026-02-12
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K201920 — Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.·cleared 2020-09-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.