CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

Olympus MAJ- Use Suction Valves recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Olympus MAJ- Use Suction Valves, distributed nationwide in the US. The recall was initiated on 1 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: 88H, 89H, 8XH, 8YH, 8ZH, 91H

Quantity recalled310000

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2148-2019
FDA event ID: 82519
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 Apr 2019
FDA classified: 2 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

1 Apr 2019	Recall initiated by company
2 Aug 2019	Classified by FDA	+123 days
14 Aug 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

The products were distributed US Nationwide.

Nationwide

Questions about this recall

Is Olympus MAJ- Use Suction Valves recalled?

Yes. Olympus Corporation of the Americas recalled Olympus MAJ- Use Suction Valves on 1 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-2148-2019.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

The products were distributed US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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