FDA Device recall Z-1489-2026
Olympus Single Use Biopsy Valve
- FDA Device
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Olympus Single Use Biopsy Valve by Olympus, citing potential for rubber fragment detachment during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1489-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-29 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Reason
Potential for rubber fragment detachment during use.
Identifiers
| code_info | Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1489-2026%22
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