Voluntary Recall of Specific Lots of Reusable TENS Electrodes
Covidien is voluntarily recalling specific lots of reusable TENS electrodes because manufacturing process exposure to an employee with a minor cut may have occurred.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where potential exposure to a biological hazard (minor cut) has not yet resulted in reported illness or injury, fitting the 'High' severity criteria for risk-of-harm products without reported harm.
Plain-English summary
Covidien LLC dba Uni-Patch is conducting a voluntary recall of specific lots of reusable, self-adhering TENS/NMES/FES electrodes. The recall involves 3,594 pouches distributed nationwide, including in California, Illinois, Massachusetts, Minnesota, and South Dakota. The affected lots are 202404, 202506, and 203431.
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. This potential exposure raises concerns regarding the sterility and safety of the medical devices.
Consumers and healthcare facilities should stop using the affected lots immediately and contact the manufacturer or their supplier for instructions on how to return or dispose of the product. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 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 electrocardi
- Manufacturer
- Covidien LLC dba Uni-Patch
- Category
- Medical Device — Electrodes
- Hazard
- Affected units
- 3,594
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 (3)
- Lots 202404
- 202506
- 203431
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
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