Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0501-2013·Announced 2012-12-19

Voluntary Recall of Empi STIMC RE Self Adhesive Electrodes

Covidien is voluntarily recalling specific lots of Empi STIMC RE Self Adhesive electrodes because manufacturing exposure to an employee with a minor cut may have occurred.

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: The recall is classified as FDA Class II, but the source text describes a voluntary precautionary recall based on a theoretical exposure risk (minor cut) without reported illnesses or injuries, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary actions.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for specific lots of Empi STIMC RE Self Adhesive electrodes. These electrodes are used for TENS, NMES, and FES applications and are a DJO brand product manufactured by Covidien LLC dba Uni-Patch.

The recall is voluntary and was initiated because it was determined that during the manufacturing process, the surface of the wires in the affected lots may have been exposed to an employee who had a minor cut. The affected lots are 200300 and 201203, and the total quantity involved is 28,138 pouches.

The products were distributed nationwide, including in California, Illinois, Massachusetts, Minnesota, and South Dakota. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product: Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand 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: 28,138

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 200300 and 201203

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 Performa TENS Electrodes Due to Manufacturing Exposure
FDA (Devices) · 2012-12-19
High
Voluntary Recall of Specific Lots of Reusable TENS Electrodes
FDA (Devices) · 2012-12-19

Same hazard · contamination