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
What this means
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
The agency's original wording
Hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Intended for
Adults
Illnesses reported
None reported
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 recalls
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- FDA-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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