FDAClass IIMarch 6, 2013

Aesculap Bipolar Generator Foot Pedal recall

Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.

Why was Aesculap Bipolar Generator Foot Pedal recalled?

The bipolar energy did not stop after release of the foot pedal.

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?

Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12

Product
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
Recalling firm
Aesculap, Inc.
Quantity
59
Distribution
USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.
Recall date
March 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls