Recall Z-2148-2019— Olympus Corporation of the Americas

Name: FDA recall Z-2148-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-01

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2019-04-01, terminated 2020-06-09. It names one FDA 510(k) clearance: K920025. 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.. Reason: There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2019-04-01
Terminated: 2020-06-09
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K920025 — OLYMPUS DISPOSABLE SUCTION VALVEOlympus Corp.·cleared 1992-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.