Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-121...
FDA Recall #Z-1489-2026 — Class II — January 29, 2026
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.
Recalling Firm
Olympus Corporation of the Americas — Center Valley, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,276 boxes (20 units per box)
Distribution
US Nationwide distribution.
Code Information
Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated