Official recall notice
FDA DeviceClass IINotable
FDA Recall: Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
- Recall date
- 2026-04-01
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Recommended action
What to do
2,929 units
Product description
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.