FDAClass IIAugust 14, 2024

The Everest Bipolar Cutting Forceps are intended to be recall: Sterility Concern

The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the…

Why was The Everest Bipolar Cutting Forceps are intended to be recalled?

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

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?

UDI: N/A Batch Numbers: FR150448 FR154445 FR173022

Product
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the…
Recalling firm
Olympus Corporation of the Americas
Quantity
100 unirs
Distribution
Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.
Recall date
August 14, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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