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
- Multiple Retailers
- 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: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
- Sold at
- Multiple Retailers
- 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 OER-Elite is an automated endoscope reprocessor used by healthcare facilities to clean and disinfect endoscopes between patients.
Why This Is Dangerous
Incompatibility of MAJ-1443/MAJ-1444 with the OER-Pro and OER-Elite could compromise reprocessing efficacy, increasing infection risk.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Facilities may need to halt use of affected reprocessors and coordinate with Olympus for remediation, potentially impacting patient throughput and facility costs.
Practical Guidance
How to identify if yours is affected
- Verify model number N5789340 on your OER-Elite unit.
- Cross-check catalog number N5789340 and any MAJ modules MAJ-1443/MAJ-1444.
Where to find product info
Recall notice and enforcement page linked in FDA recall reporting. Manufacturer communications and facility service records.
What timeline to expect
Remedy timelines are provided by Olympus in the recall notice; healthcare facilities should anticipate guidance within weeks.
If the manufacturer is unresponsive
- Escalate to hospital biosafety officer and Olympus recall liaison.
- File a complaint with the FDA if the manufacturer is unresponsive or if patient risk persists.
How to prevent similar issues
- Verify compatibility before deploying MAJ modules with reprocessors.
- Maintain updated service agreements and recall communication channels.
- Document all firmware/modification changes and module replacements.
- Train staff on recognizing non-compatible configurations.
- Monitor infection-control metrics during remediation.
Documentation advice
Keep the recall notification, vendor communications, and service records. Photograph serial numbers and MAJ modules for records.
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Product Details
Model numbers: OER-Elite, N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers. Distribution: US Nationwide distribution. Quantity: 2,929 units. Sold at: Not specified in recall notice. Price: Not specified.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- MAJ-1443 and MAJ-1444 incompatibility
- OER-Pro and OER-Elite affected
- No injuries reported
- Notice served by letter
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Safety Guide
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