Olympus Corporation of the Americas: Medical Device Recall in 2019 - (Recall #: Z-2148-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 1, 2019

Date Posted: August 14, 2019

Recall Number: Z-2148-2019

Event ID: 82519

Reason for Recall:

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

Status: Terminated

Product Quantity: 310000

Code Information:

Lot numbers: 88H, 89H, 8XH, 8YH, 8ZH, 91H

Distribution Pattern:

The products were distributed US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated