Recall Z-1905-2026 ยท FEB Accessories, Cleaning, For Endoscope
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
| Date | Apr 22, 2026 (initiated Mar 25, 2026) |
| Status | Open, Classified |
| Reason | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Root cause | Device Design |
| Action | Olympus notified consignees on about 03/25/2026 via letter titled "URGENT: MEDICAL DEVICE REMOVAL." Consignees were notified of the issue and hazard involved and were instructed to examine inventory and OER-ELITE devices for the affected product. The current version has black lock levers. The previous versions have gray lock levers or integrated lock levers, which are the same color as the rest of the connector. Consignees were instructed that if they have sufficient quantities of the current version (black) to support reprocessing needs, stop using the previous version and set aside for retu |
| Quantity | 1,929 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. |
| 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 |