Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Recall Insight

This FDA Devices action (record #Z-0498-2013) was formally reported on December 19, 2012, with the manufacturer initiating the action on February 9, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Covidien LLC dba Uni-Patch is listed as the recalling firm, operating out of Wabasha, MN. Federal records list the affected scope as 2,014 pouches.

The documented reason for this recall is: 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 emp… Distribution data in the federal record shows the product reached: Nationwide Distribution including CA, IL, MA, MN, and SD.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.