FDA DeviceClass IINotable

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

Date: 2026-04-01
Brand: Olympus Corporation of the Americas
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

3,354 units

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