HIGH

Olympus OER-Pro Endoscope Reprocessor Recall for 3,354 Units Over MAJ-1443/1444 Compatibility (2026)

Olympus Corporation of the Americas recalled 3,354 units of the OER-Pro endoscope reprocessor on February 12, 2026. MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals and clinics should stop using the device immediately and follow the manufacturer’s recall instructions.

Quick Facts at a Glance

Recall Date
February 12, 2026
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Olympus OER-Pro is an automated endoscope reprocessor used in healthcare facilities to clean and disinfect endoscopes. The MAJ-1443 and MAJ-1444 components previously supported its reprocessing function. Users rely on compatible upgrades to ensure effective sterilization.

Why This Is Dangerous

The MAJ-1443/MAJ-1444 upgrades are no longer compatible with the OER-Pro and OER-Elite reprocessors, which could impair reprocessing effectiveness.

Industry Context

This recall is not indicated as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics must halt use of the affected devices and await manufacturer instructions. The situation could disrupt endoscope reprocessing workflows and require procurement of compatible replacements.

Practical Guidance

How to identify if yours is affected

  1. Confirm model N3058140 is in use.
  2. Check if MAJ-1443 and/or MAJ-1444 upgrades are installed or planned.
  3. Look for a manufacturer recall notice or letter in your facility records.

Where to find product info

Check the unit label for Model N3058140 and UDI-DI 04953170258589; review the recall page linked by FDA and Olympus communications.

What timeline to expect

The manufacturer has not published a universal timeline for replacement or remediation beyond the recall instruction period.

If the manufacturer is unresponsive

  • Escalate to hospital procurement and biomedical engineering leadership
  • Document all communications with Olympus
  • Consider filing a report with the FDA if concerns persist (as appropriate in your jurisdiction)

How to prevent similar issues

  • Verify compatibility lists before applying upgrades to reprocessors
  • Maintain an updated inventory of reprocessing equipment and model numbers
  • Establish a clear procedure for recalls and equipment decommissioning
  • Train staff on recognizing recall notices and following vendor instructions

Documentation advice

Retain the recall letter, unit labels, model numbers, and all correspondence with Olympus for records and potential audits.

Product Details

Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers. Quantity: 3,354 units. Distribution: US nationwide.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 3,354 units affected
  • MAJ-1443/MAJ-1444 incompatibility with OER-Pro and OER-Elite
  • Model N3058140; UDI-DI 04953170258589
  • US nationwide distribution
  • Recall status: ACTIVE

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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