Recall

Class III — Gynex Corporation

Recalling firm	GYNEX CORP.
Registered facility	Gynex Corporation (the firm's only registered facility)
Classification	Class III
Status	Terminated
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.
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.
Quantity	19 boxes (containing 12 electorde hand pieces each)
Distribution	Nationwide Distribution
Initiated	2012-09-06
Classified	2012-10-03
Terminated	2012-10-22
Recall number	Z-0008-2013
Initiation	Voluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class III recall — Gynex Corporation (Z-0008-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63253/

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