The Recall Desk

FDA (Devices) recall action 98240

Olympus Corporation of the Americas recalled 2 products on 2026-03-11

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2026-03-11
Critical
0
Units
—

Why these products were recalled

Potential for rubber fragment detachment during use.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Devices)··2026-03-11

    Olympus biopsy valve MAJ-1218 may shed rubber fragments during use

    Olympus is recalling all lots of its Single Use Biopsy Valve, model MAJ-1218, because of the potential for rubber fragment detachment during use.

    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-03-11

    Olympus single use biopsy valve may shed rubber fragments during use

    Olympus is recalling all lots of its Single Use Biopsy Valve, model MAJ-210, because of the potential for rubber fragment detachment during use.

    Product
    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.
    Category
    Distribution
    0 states