FDA-Device2026-04-01Class II
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Olympus Corporation of the Americas
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-1610-2026Original summary
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers. Distribution: US Nationwide distribution. Affected quantity: 47,383 units
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