FDA recall Z-1612-2026

Olympus Corporation of the Americas · Class II · device

Product

Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

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

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-02-12
Report date
2026-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1612-2026