Z-0887-2013Class II

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

Name: Z-0887-2013 Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation
Creator: Aesculap, Inc.
Published: 2013-01-18
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2013-01-18 / Terminated / root cause: manufacturing process

FDA source

Aesculap, Inc. began a recall of Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation on 2013-01-18. FDA classified it as Class II and gives the reason as "The bipolar energy did not stop after release of the foot pedal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0887-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-18
Posted: 2013-02-26
Terminated: 2014-01-08
Recalling firm: Aesculap Inc
Product: Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The bipolar energy did not stop after release of the foot pedal.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Aesculap AG sent an Important Recall Notification letter dated January 21, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return for a replacement product or credit. The letter included an inventory sheet to be completed by the customer and returned to the recalling firm. For question call 610-984-9265 or 610-984-9291.
Quantity in commerce: 59
Distribution: USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.
Product codes and lots: Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0887-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0887-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)