← FDA ENFORCEMENT
Z-1613-2026Class II

Olympus Corporation of the Americas

Recalling firm
Olympus Corporation of the Americas
Product type
Device
Status
Ongoing
Report date
2026-04-01
Distribution
US Nationwide distribution.
Firm state
PA
Product quantity
3,354 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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

Product description

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

Code / lot info

Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.

Other recalls SPEQ maps to Risk Management & CAPA
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.