Z-1613-2026 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
April 1, 2026
Initiation Date
February 12, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,354 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Code Information

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