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

Recalled August 14, 2019 · FDA recall Z-2148-2019 · Olympus Corporation of the Americas

Hazard

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

Units

310000

Sold at

The products were distributed US Nationwide.

Description

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

Product

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.

Manufacturer(s)

Olympus Corporation of the Americas

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →