Olympus Corporation of the Americas Recall 95898
Description: Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
Olympus Corporation of the Americas Recall 95898 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0905-2025 |
| Event ID | 95898 |
| Event Description | Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories. |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 30,140 units |
| Recall Reason | Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device. |
| Device Classification | 20250122 |
| Device Code Info | Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers. |
| Center Classification Date | 20250116 |
| Recall Initiation Date | 20241218 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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