FDA Medical Device Recalls (openFDA)
Aesculap, Inc.: Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
- Recall number
- Z-0887-2013
- Recalling firm
- Aesculap, Inc.
- Product
- Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
- Status
- Terminated
- Initiated
- 2013-01-18
- Posted
- 2013-02-26
- Terminated
- 2014-01-08
- Reason
- The bipolar energy did not stop after release of the foot pedal.
- 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
- 59
- Distribution
- USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.
- Lot, serial or model codes
- Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12
- 510(k) numbers
- not on file
- 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