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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 i

Medical DevicesSource: FDA (device) · Date: 2026-03-11

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
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.
Reason / hazard
Potential for rubber fragment detachment during use.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-01-29
Code info
Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.
Product quantity
1,276 boxes (20 units per box)
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
98240
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