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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Olympus Corporation of the Americas
- Product type
- Endoscope Reprocessor
- Model numbers
- Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 12, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Confirm model N3058140 is in use.
- Check if MAJ-1443 and/or MAJ-1444 upgrades are installed or planned.
- 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.
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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
- MAJ-1443/MAJ-1444 incompatibility with OER-Pro and OER-Elite
- Model N3058140; UDI-DI 04953170258589
- US nationwide distribution
- Recall status: ACTIVE
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Safety Guide
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