Gynex Electrosurgical Electrode Holder Recalled Due to Assembly Error
Gynex Corporation is recalling 19 boxes of electrosurgical electrode holders because an incorrect connector pin was attached during assembly, rendering the devices unusable.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the defect renders the device unusable without causing harm, fitting the criteria for cosmetic or documentation issues with no reported injuries.
Plain-English summary
Gynex Corporation is recalling 19 boxes of sterile, single-use, disposable electrosurgical electrode holders (Gynex catalog number 950). The affected units are identified by manufacturer's lot number 54-12-2-21-12. These devices are used in gynecological procedures to connect electrodes to a foot-activated electric generator for cutting tissue and controlling bleeding.
The recall was initiated because the wrong electrical connector pin was attached to the cord during assembly by the manufacturer. This specific connector is too large to fit into the port on the foot-activated generator, which makes the device unusable. The source text does not report any injuries, illnesses, or adverse health consequences associated with this defect.
The affected products were distributed nationwide. Healthcare facilities and users should stop using the recalled electrode holders and contact Gynex Corporation for further instructions regarding the return or disposal of the units.
The recalled product
- 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…
- Manufacturer
- Gynex Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Manufacturer's lot number: 54-12-2-21-12.
Distribution
Distributed nationwide across the United States.
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