FDA-Device2026-03-11Class II
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Olympus Corporation of the Americas
Hazard
Potential for rubber fragment detachment during use.
Sold states
US Nationwide distribution.
Affected count
95,882 boxes (20 per box)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1488-2026Original summary
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids. Potential for rubber fragment detachment during use. Model/Catalog Number: MAJ-210. UDI-DI: 14953170152433, 14953170452069. All Lot Numbers. 20 units per box. Distribution: US Nationwide distribution. Affected quantity: 95,882 boxes (20 per box)
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