FDA DevicesClass II
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Published: April 1, 2026Recall ID: Z-1612-2026Category: devicesCountry: US
Reason for Recall / Hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Product Description & Identification
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98371 |
| Address 1 | 3500 Corporate Pkwy |
| Code info | Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers. |
| Postal code | 18034-8229 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 2,929 units |
| Reason for recall | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260212 |
| Initial firm notification | Letter |
| Center classification date | 20260320 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.