FDA Medical Device Recalls (openFDA)
Gynex Corporation: Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
- Recall number
- Z-0008-2013
- Recalling firm
- Gynex Corporation
- Product
- Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
- Status
- Terminated
- Initiated
- 2012-09-06
- Posted
- 2012-10-03
- Terminated
- 2012-10-22
- Reason
- The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were first notified by phone with a follow up e-mail or fax. The consignees were asked to complete the response section regarding the destruction/return of the device. For questions regarding this recall call 425-882-1179.
- Quantity
- 19 boxes (containing 12 electorde hand pieces each)
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Manufacturer's lot number: 54-12-2-21-12.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HGI
- Firm FEI
- 3001238683
- Firm city
- Redmond
- Firm state
- WA
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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