Z-1489-2026 Class II Ongoing
FDA device recall Z-1489-2026 was initiated by Olympus Corporation of the Americas on January 29, 2026 and is designated Class II. Reason for recall: Potential for rubber fragment detachment during use. The recall status is ongoing. Affected quantity: 1,276 boxes (20 units per box).
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2026
- Initiation Date
- January 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,276 boxes (20 units per box)
Product Description
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 for Recall
Potential for rubber fragment detachment during use.
Distribution Pattern
US Nationwide distribution.
Code Information
Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.