Pediatric ThermoGard¿ Dual Dispersive Electrodes — Class II medical device recall Z-2597-2016
Terminated recall by Conmed Corporation, reported 2016-08-31, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placin
| Recall number | Z-2597-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conmed Corporation, Utica, NY, United States |
| Recall initiated | 2016-05-18 |
| Classified | 2016-08-19 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2018-05-24 |
| Distributed | 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, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AE, AU, BE, CA, CN, ES, FR, GT, HK, IL, IT, JP, KR, MX, MY, NO, NZ, PT, SA, SE |
| Quantity | 6,640 units |
| Lot numbers | 141001X, 20150705X |
| Model numbers | 51-7710 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2597-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.