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.
What this means for you
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
- 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
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 →Related recalls
Same manufacturer · Covidien LLC dba Uni-Patch
See all →- ModerateVoluntary Recall of Specific Lots of TENS Electrodes Due to Manufacturing Exposure
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FDA (Devices) · 2012-12-19
- HighVoluntary Recall of Specific Lots of Reusable TENS Electrodes
FDA (Devices) · 2012-12-19
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