FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
OTHERNationwide distribution
Stop using Olympus MAJ-1443 suction valve with OER reprocessors
Olympus endoscope suction valves (models MAJ-1443 and MAJ-1444) are no longer compatible with Olympus OER-Pro and OER-Elite automated cleaning systems. Using these valves with these reprocessors may result in improper cleaning and sterilization of medical equipment.
- Discontinue use of MAJ-1443 and MAJ-1444 suction valves with OER-Pro and OER-Elite reprocessors
- Contact Olympus Corporation for guidance on replacement parts or alternative reprocessing methods
- Review your endoscope equipment inventory to identify affected units
Hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Sold states
US Nationwide distribution.
Affected count
47,383 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1610-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus OER-Pro endoscope reprocessor incompatible with MAJ-1443 and MAJ-1444 adapters
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