Recall Ledger

Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. ... recall (Olympus Corporation of the Americas)

Medical deviceClass IIOngoing

Summary: Olympus Corporation of the Americas is recalling 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.. Reason: Potential for rubber fragment detachment during use.

What is being recalled

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.

Why

Potential for rubber fragment detachment during use.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution.

How to tell if yours is affected

Model/Catalog Number: MAJ-210. UDI-DI: 14953170152433, 14953170452069. All Lot Numbers. 20 units per box.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1488-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJanuary 29, 2026
ReportedMarch 11, 2026
CompanyOlympus Corporation of the Americas
Company locationCenter Valley, PA, United States
Initiated byVoluntary: Firm initiated
Quantity95,882 boxes (20 per box)

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