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-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
- FDA-Device2026-07-22Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
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