Olympus Corporation of the Americas recalls Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be att…

Recall date

April 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2148-2019

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

The products were distributed US Nationwide.

Why it was recalled

There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.