FDA recall, , Moderate risk
Olympus Endoscope Valves and Reprocessors
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, began a recall on February 12, 2026, for the Olympus Endoscope Suction Valve MAJ-1443 and the Olympus Endoscope Air/Water Valve MAJ-1444. The recall was added to the FDA's Enforcement Report and classified on March 20, 2026, with distribution nationwide. The agency stated that the MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Match the UDI-DI and model code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Olympus Endoscope Suction Valve - MAJ-1443.
- UDI-DI
- 04953170355912
- Lot code
- All Lot/Serial Numbers.
Olympus Endoscope Reprocessor OER-Pro.
- UDI-DI
- 04953170258589
- Model code
- N3058140.
- Lot code
- All Lot/Serial Numbers.
Olympus Endoscope Air/Water Valve - MAJ-1444.
- UDI-DI
- 04953170355929
- Model code
- MAJ-1444.
- Lot code
- All Lot/Serial Numbers.
Olympus Endoscope Reprocessor OER-Elite.
- UDI-DI
- 04953170404047
- Model code
- N5789340.
- Lot code
- All Lot/Serial Numbers.
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98371
- Recall numbers
- Z-1610-2026 to Z-1613-2026
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
