MACROLYTE Premie Dispersive Electrode — Class II medical device recall Z-1719-2014
Terminated recall by ConMed Corporation, reported 2014-06-11, distributed nationwide. ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connectio
| Recall number | Z-1719-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2014-05-08 |
| Classified | 2014-06-04 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2017-04-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, EC, ES, FI, FR, GB, HN, ID, IL, IN, IT, JP, LB, LV, MX, MY, PA, PH, PT, SA, SV, TH, TT, UY, ZA |
| Lot numbers | 1204275, 1401075 |
| Model numbers | 440-2400 |
Product
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Reason for recall
ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.
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-1719-2014. 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.