Covidien LLC dba Uni-Patch: Medical Device Recall in 2012 - (Recall #: Z-0499-2013)

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, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Product Classification:

Class II

Date Initiated: February 9, 2012

Date Posted: December 19, 2012

Recall Number: Z-0499-2013

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: 3594 pouches

Code Information:

Lots 202404, 202506, 203431,

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated