FDA Device recall Z-0905-2025
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type)
- FDA Device
- Class I
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class I recall of Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type) by Olympus, citing potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0905-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-12-18 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0905-2025%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.