Z-2148-2019Class II

Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209

Name: Z-2148-2019 Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209
Creator: Olympus Corporation of the Americas
Published: 2019-04-01
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2019-04-01 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2019-04-01. FDA classified it as Class II and gives the reason as "There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2148-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-01
Posted: 2019-08-02
Terminated: 2020-06-09
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Medical Device Correction letters dated 4/1/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions call 484-896-5688.
Quantity in commerce: 310000
Distribution: The products were distributed US Nationwide.
Product codes and lots: Lot numbers: 88H, 89H, 8XH, 8YH, 8ZH, 91H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2148-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2148-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02

Product code EOQ

K920025Class IIOlympus Disposable Suction ValveOlympus Corp. / cleared 1992-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)