FDA Device recall Z-1612-2026
Olympus Endoscope Reprocessor OER-Elite
- FDA Device
- Class II
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class II recall of Olympus Endoscope Reprocessor OER-Elite by Olympus, citing the MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1612-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-12 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Reason
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Identifiers
| code_info | Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1612-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.