Olympus OER-Elite Reprocessor Class II Recall Z-1612-2026
Summary
FDA issued Class II recall Z-1612-2026 for Olympus OER-Elite Endoscope Reprocessor (Model N5789340) due to incompatibility of MAJ-1443 and MAJ-1444 reprocessing components with OER-Pro and OER-Elite automated endoscope reprocessors. The recall affects devices distributed nationwide. Healthcare facilities using these reprocessors must identify affected units and take corrective action.
What changed
FDA issued Class II medical device recall Z-1612-2026 for Olympus OER-Elite Endoscope Reprocessor (Model N5789340). The recall was initiated due to incompatibility issues where MAJ-1443 and MAJ-1444 reprocessing components no longer function properly with OER-Pro and OER-Elite automated endoscope reprocessors. This affects devices distributed throughout the United States.
Healthcare facilities utilizing Olympus OER-Elite reprocessing systems must immediately assess their inventory for affected units and discontinue use of incompatible components. Medical device users should contact Olympus Corporation of the Americas for guidance on replacement options and corrective actions. Continued use of incompatible reprocessing components may result in improper endoscope sterilization, posing infection control risks to patients undergoing endoscopic procedures.
What to do next
- Identify and locate all OER-Elite reprocessors (Model N5789340) in your facility
- Cease use of MAJ-1443 and MAJ-1444 reprocessing components with affected devices
- Contact Olympus Corporation of the Americas for replacement options and corrective measures
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-1612-2026 · 20260401 · Ongoing
Product
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.
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API
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