Recall Z-1612-2026 ยท FEB Accessories, Cleaning, For Endoscope
Olympus Corporation of the Americas
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
| Date | Mar 20, 2026 (initiated Feb 12, 2026) |
| Status | Open, Classified |
| Reason | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. |
| Root cause | Reprocessing Controls |
| Action | Olympus notified consignees on about 02/12/2026 via URGENT: MEDICAL DEVICE CORRECTION letter. Consignees were instructed to immediately cease reprocessing the MAJ-1443 and MAJ-1444 valves in an OER-Pro or OER-Elite and ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the full extent of the MAJ-1443 and MAJ-1444 reprocessing steps as detailed in the provided Instructions for Use (IFU). The updated IFU can also be accessed electronically through OlympusConnect.com. Additionally, consignees were instructed to replace any existing |
| Quantity | 2,929 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201920 | Endoscope Reprocessor OER-Elite Olympus Medical Systems Corp., Sep 1, 2020 |