FDAClass IIOctober 7, 2015

Histolock Resection Device recall: Sterility Concern

Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during…

Why was Histolock Resection Device recalled?

The company has determined the sterility cannot be assured for the affected lot.

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?

M/N: 00711117; Lot #: 1505956

Product
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during…
Recalling firm
US Endoscopy Group Inc
Quantity
41 units
Distribution
US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
Recall date
October 7, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls