Changeflow GovPing Healthcare Olympus OER-Pro Endoscope Reprocessor Recall - ...
Urgent Enforcement Amended Final

Olympus OER-Pro Endoscope Reprocessor Recall - MAJ-1443/MAJ-1444 Compatibility Issue

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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

  1. Identify OER-Pro units (model N3058140) in your facility
  2. Stop using MAJ-1443 and MAJ-1444 accessories with affected reprocessors
  3. Contact Olympus for replacement or compatibility information

Archived snapshot

Apr 10, 2026

GovPing 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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Last updated

Classification

Agency
FDA
Filed
April 1st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Class II Z-1613-2026

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall response Endoscope reprocessing
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Product Safety

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