Class IIReported 2026-04-01

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

Recalled by Olympus Corporation of the Americas

Reason for Recall

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

Recall Number

Z-1613-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-02-12

Reported

2026-04-01

Distribution

US Nationwide distribution.

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.