FDA Device recall Z-0501-2013
Empi STIMC RE Self Adhesive electrodes
- FDA Device
- Class II
- terminated
- Published 2012-12-19
On 2012-12-19 the FDA classified a Class II recall of Empi STIMC RE Self Adhesive electrodes by Covidien, citing covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0501-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-02-09 |
| Published | 2012-12-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien |
| Distribution | US |
Product
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Reason
Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.
Identifiers
| code_info | Lots 200300 and 201203 |
|---|
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-0501-2013%22
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