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Recall Observatory FDA recall evidence

Device product

Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

Z-1610-2026

February 12, 2026

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 98371
Status
Ongoing
Classification
Class II
Quantity
47,383 units
Official record key
device-enforcement:Z-1610-2026

Official wording

Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Code information: Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.