Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 ...

FDA Recall #Z-1488-2026 — Class II — January 29, 2026

Recall #Z-1488-2026 Date: January 29, 2026 Classification: Class II Status: Ongoing

Product Description

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 for Recall

Potential for rubber fragment detachment during use.

Recalling Firm

Olympus Corporation of the Americas — Center Valley, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

95,882 boxes (20 per box)

Distribution

US Nationwide distribution.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated