Z-2597-2016Class II

Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number...

Name: Z-2597-2016 Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number...
Creator: Conmed Corporation
Published: 2016-05-18
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2016-05-18 / Terminated / root cause: design

FDA source

Conmed Corporation began a recall of Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and... on 2016-05-18. FDA classified it as Class II and gives the reason as "A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2597-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-18
Posted: 2016-08-19
Terminated: 2018-05-24
Recalling firm: ConMed Corporation
Product: Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
Root cause tag: design
FDA root cause: Device Design
Action: On May 17, 2016 CONMED Corporation distributed Urgent Device Recall notification letters and Business Reply Forms to their customers via courier service. CONMED Corporation has decided to recall these ThermoGard Dual Dispersive Electrodes for all customers who do not use an electrosurgical generator that employs the Contact Quality Monitoring systems listed. If your electrosurgical generator is not listed, your generator should not be used with the lot codes of the ThermoGard Dual Dispersive Electrodes identified. Customers are advised to inspect inventory for any of the recalled devices. If you use the ThermoGard Dual Dispersive Electrodes in conjunction with an electrosurgical generator listed, no further action is required. However, if your electrosurgical generator and CQM system is not listed above, do not use the affected lot codes of ThermoGard Dual Dispersive Electrodes. Please note that ThermoGard Dual Dispersive Electrodes produced after July 5, 2015, are not subject to this recall. Customers should contact all of those departments or organizations within their facility and any other facilities that you may have supplied or given these affected products to. It is imperative that all end users of these devices receive this notice and respond immediately. If you have questions, please contact Patricia Cotter, CONMED Recall Coordinator 315-624-3237 (8AM-5PM EST, M-F) or fax to 315-624-3225 or email [email protected].
Quantity in commerce: 6,640 units
Distribution: Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.
Product codes and lots: Beginning Lot Code 141001X with Ending Lot Code 20150705X.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2597-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2595-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2596-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2597-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2598-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2599-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19

Product code GEI

K140658Class IIThermogard Dispersive Electrodes, Thermogard Plus Abc Dispersive ElectrodesConmed Corporation / cleared 2014-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)