FDAClass IIJune 21, 2017

Video Bronchoscope recall

Video Bronchoscope

Why was Video Bronchoscope recalled?

This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.

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?

Model #'s: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK and EB-1970UK

Product
Video Bronchoscope
Recalling firm
Pentax of America Inc
Quantity
1,349 - (Total - US) and 352 (Total - OUS)
Distribution
US Nationwide and Internationally
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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