Covidien LLC dba Uni-Patch: Medical Device Recall in 2012 - (Recall #: Z-0498-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 9, 2012

Date Posted: December 19, 2012

Recall Number: Z-0498-2013

Event ID: 61209

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2,014 pouches

Code Information:

Lots 202028 and 202722

Distribution Pattern:

Nationwide Distribution including CA, IL, MA, MN, and SD.

Voluntary or Mandated:

Voluntary: Firm initiated