FDA DevicesClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116...
Published: April 29, 2026Recall ID: Z-1904-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product Description & Identification
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98544 |
| Address 1 | 3500 Corporate Pkwy |
| Address 2 | N/A |
| Code info | Model: MAJ-2116. UDI Number: 04953170404115. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 25A, 26A, 27A, 28A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 51A. |
| Postal code | 18034-8229 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 373 units |
| Reason for recall | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260325 |
| Initial firm notification | Letter |
| Center classification date | 20260422 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.