Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

Recall date
February 12, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1613-2026
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
US Nationwide distribution.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

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