Olympus OER-Pro Endoscope Reprocessor Recall - MAJ-1443/MAJ-1444 Compatibility Issue
Summary
Olympus OER-Pro Recall, Class II, 1st Apr
What changed
Olympus Corporation of the Americas initiated a Class II recall for the OER-Pro automated endoscope reprocessor (model N3058140) due to incompatibility with MAJ-1443 and MAJ-1444 reprocessing accessories. The affected products were distributed nationwide throughout the United States. The recall is currently ongoing.
Healthcare facilities using these endoscope reprocessors must immediately identify affected units, discontinue use of incompatible accessories, and contact the manufacturer for guidance. Medical device makers and healthcare providers should review their inventory management and reprocessing protocols to ensure compliance with FDA safety requirements.
What to do next
- Identify OER-Pro units (model N3058140) in your facility
- Stop using MAJ-1443 and MAJ-1444 accessories with affected reprocessors
- Contact Olympus for replacement or compatibility information
Archived snapshot
Apr 10, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Olympus Corporation of the Americas
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1613-2026 · 20260401 · Ongoing
Product
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Reason for Recall
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API
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