Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0500-2013·Announced 2012-12-19

Voluntary Recall of Performa TENS Electrodes Due to Manufacturing Exposure

Covidien is voluntarily recalling specific lots of Performa 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 for a theoretical contamination risk (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 Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes. The recall involves 3,290 units from Lot 202406.

The recall was initiated 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. This exposure occurred during the production of the cutaneous electrodes, which are applied directly to a patient's skin to apply electrical stimulation.

The affected products were distributed nationwide, including in California, Illinois, Massachusetts, Minnesota, and South Dakota. Consumers and healthcare providers should stop using the recalled electrodes and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, 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.
Manufacturer: Covidien LLC dba Uni-Patch
Category: Medical Device — Electrodes
Hazard: contamination
Affected units: 3,290

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)

Lot 202406

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 Specific Lots of 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