FDAClass IIAugust 14, 2019

Olympus MAJ-209 Single Use Suction Valves recall

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…

Why was Olympus MAJ-209 Single Use Suction Valves recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Olympus Corporation of the Americas
Quantity
310000
Distribution
The products were distributed US Nationwide.
Recall date
August 14, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls