FDAClass IINovember 20, 2019

EndoTool SubQ recall

EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

Why was EndoTool SubQ recalled?

Product was distributed prior to approval or clearance from FDA.

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?

versions: v 1.7.1, 1.7.4, 1.7.5

Product
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Recalling firm
Monarch Medical Technologies
Quantity
6 units
Distribution
SC, IL IN, CA
Recall date
November 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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