FDA Medical Device Recalls (openFDA)
Aesculap, Inc.: Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
- Recall number
- Z-0479-2014
- Recalling firm
- Aesculap, Inc.
- Product
- Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
- Status
- Terminated
- Initiated
- 2013-09-10
- Posted
- 2013-12-11
- Terminated
- 2014-10-20
- Reason
- Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
- Root cause
- Device Design
- Action
- Aesculap sent an Important Recall Notification letter dated September 23, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return affected product and receive replacement product or credit. An Inventory Sheet is attached and must be completed. For questions call 610-984-9265 or 610-984-9414.
- Quantity
- 85
- Distribution
- Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.
- Lot, serial or model codes
- all GN161's distributed between 4/28/2009 and 5/22/2013.
- 510(k) numbers
- ["K952524"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28