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 Suction Valve
- Model numbers
- Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. 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 suction valves MAJ-1443 and MAJ-1444 are components used with Olympus reprocessing equipment to clean and sterilize endoscopes. They are intended to be compatible with OER-Pro and OER-Elite systems.
Why This Is Dangerous
The valves are no longer reprocessing compatible with the specified reprocessors, which may compromise sterilization when used in routine reprocessing cycles.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics may need to adjust reprocessing workflows or obtain replacement valves to ensure proper sterilization. No injuries have been reported to date.
Practical Guidance
How to identify if yours is affected
- Verify model number MAJ-1443 or MAJ-1444.
- Check the UDI-DI 04953170355912.
- Check Catalog Number N5363430.
- Confirm all Lot/Serial Numbers are affected.
Where to find product info
UDI-DI on product packaging; Catalog Number on label on the device or packaging.
What timeline to expect
Timeline for refunds or replacements is not specified in the recall notice.
If the manufacturer is unresponsive
- Document all attempts to contact Olympus.
- Escalate to hospital compliance or regulatory authorities if needed.
How to prevent similar issues
- Verify reprocessor compatibility before use.
- Maintain an up-to-date inventory of endoscope reprocessing components.
- Exercise strict adherence to manufacturer recall notices.
Documentation advice
Keep the recall letter, model numbers MAJ-1443/MAJ-1444, UDI-DI 04953170355912, Catalog Number N5363430, and all correspondence with Olympus.
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Product Details
Model numbers: MAJ-1443 and MAJ-1444. Sold in the United States via nationwide distribution. Sold date and price not disclosed. Quantity: 47,383 units. Catalog Number: N5363430. UDI-DI: 04953170355912. All Lot/Serial Numbers affected.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- MAJ-1443 and MAJ-1444 models
- Incompatibility with OER-Pro and OER-Elite reprocessors
- US nationwide distribution
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Safety Guide
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