FDAClass IJanuary 22, 2025

Olympus MAJ-891 Forceps/Irrigation Plug recall

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument…

Why was Olympus MAJ-891 Forceps/Irrigation Plug recalled?

Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.

Product
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument…
Recalling firm
Olympus Corporation of the Americas
Quantity
30,140 units
Distribution
US Nationwide Distribution
Recall date
January 22, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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