FDA Device recall Z-0008-2013
Sterile, single-use, disposable electrosurgical electrode holder
- FDA Device
- Class III
- terminated
- Published 2012-10-10
On 2012-10-10 the FDA classified a Class III recall of Sterile, single-use, disposable electrosurgical electrode holder by Gynex, citing 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 ge….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0008-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-09-06 |
| Published | 2012-10-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Gynex |
| Distribution | US |
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.
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.
Identifiers
| code_info | Manufacturer's lot number: 54-12-2-21-12. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0008-2013%22
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