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 Air/Water Valve
- Model numbers
- Model Number: MAJ-1444. UDI-DI: 04953170355929. Catalog number: N5363530. 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
Endoscope air/water valves are components used in cleaning and functioning of endoscopes in medical settings. They are used during endoscopic procedures and reprocessing workflows.
Why This Is Dangerous
If the valve is not compatible with OER-Pro or OER-Elite reprocessors, proper cleaning and disinfection could be compromised, potentially increasing infection risk.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals may need to halt certain reprocessing steps for affected valves and await guidance from Olympus or the FDA. No injuries have been reported to date.
Practical Guidance
How to identify if yours is affected
- Verify model numbers MAJ-1443 or MAJ-1444 on the device or packaging.
- Check UDI-DI 04953170355929 and catalog number N5363530 on the label.
- Confirm the lot/serial numbers are applicable to your inventory.
Where to find product info
UDI-DI and catalog numbers are printed on device labels and packaging.
What timeline to expect
Remediation timeline not specified; expect manufacturer guidance and potential replacement or disposal instructions within weeks.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a report with the device manufacturer and FDA if necessary
- Seek guidance from your vendor or medical device distributor
How to prevent similar issues
- Verify reprocessing compatibility before selecting a reprocessor
- Monitor for recall updates from FDA and Olympus
- Use only manufacturer-approved reprocessing instructions and materials
Documentation advice
Keep recall notice, model numbers, UDI-DI, catalog number, and all correspondence with Olympus for records.
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Product Details
Model numbers: MAJ-1444 and MAJ-1443. UDI-DI: 04953170355929. Catalog number: N5363530. All Lot/Serial Numbers. Distribution: US Nationwide. Brand: Olympus Corporation of the Americas. Sold since: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- MAJ-1444 model number affected
- Reprocessors compatibility issue with OER-Pro and OER-Elite
- Active recall as of 2026-02-12
- US nationwide distribution
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Safety Guide
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