FDAHealthJanuary 29, 2026
Olympus Corporation of the Americas — 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
⚠️ Potential for rubber fragment detachment during use.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 29, 2026
US Nationwide distribution.
What's affected?
- 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.
- Lot code
- s
Additional details
Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,276 boxes (20 units per box).
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