FDA DevicesClass II
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per bo...
Published: March 11, 2026Recall ID: Z-1489-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for rubber fragment detachment during use.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98240 |
| Address 1 | 3500 Corporate Pkwy |
| Address 2 | N/A |
| Code info | Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box. |
| Postal code | 18034-8229 |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 1,276 boxes (20 units per box) |
| Reason for recall | Potential for rubber fragment detachment during use. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260129 |
| Initial firm notification | Letter |
| Center classification date | 20260303 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.