Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0498-2013·Announced 2012-12-19

Voluntary Recall of Specific Lots of TENS Electrodes Due to Manufacturing Exposure

Covidien is voluntarily recalling specific lots of TENS electrodes because wire surfaces may have been exposed to an employee with a minor cut during manufacturing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary precautionary recall initiated due to a potential manufacturing exposure to a minor cut, with no reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Covidien LLC dba Uni-Patch is conducting a voluntary recall of specific lots of reusable, non-sterile, self-adhering electrodes used for TENS/NMES. The recall involves 2,014 pouches from Lots 202028 and 202722, which were distributed nationwide, including in California, Illinois, Massachusetts, Minnesota, and South Dakota.

The recall was initiated because it was determined that during the manufacturing process, the surface of the wires in these specific lots may have been exposed to an employee who had a minor cut. The product is made in the U.S.A. and is designed to be applied directly to a patient's skin to record physiological signals or apply electrical stimulation.

Consumers and healthcare providers who have these specific lots of electrodes should stop using them and contact the recalling firm for further instructions.

The recalled product

Product: 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…
Manufacturer: Covidien LLC dba Uni-Patch
Category: Medical Device — Electrodes
Hazard: contamination
Affected units: 2,014

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lots 202028 and 202722

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Covidien LLC dba Uni-Patch under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Covidien LLC dba Uni-Patch

See all →

Moderate
Voluntary Recall of Performa TENS Electrodes Due to Manufacturing Exposure
FDA (Devices) · 2012-12-19
Moderate
Voluntary Recall of Empi STIMC RE Self Adhesive Electrodes
FDA (Devices) · 2012-12-19
High
Voluntary Recall of Specific Lots of Reusable TENS Electrodes
FDA (Devices) · 2012-12-19

Same hazard · contamination