CLASS II Device recall · Reported 19 Dec 2012 · FDA Enforcement Report

Reusable, Self-Adhering Tens/Nmes/Fes electrodes Single recalled

Covidien is recalling Reusable, Self-Adhering Tens/Nmes/Fes electrodes Single Patient Use Only, distributed nationwide in the US. The recall was initiated on 9 Feb 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 202404, 202506, 203431,

Quantity recalled3594 pouches

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0499-2013
FDA event ID: 61209
Recalling firm: Covidien, Wabasha, MN
Classification: Class II
Status: Terminated
Recall initiated: 9 Feb 2012
FDA classified: 10 Dec 2012
Reported: 19 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

9 Feb 2012	Recall initiated by company
10 Dec 2012	Classified by FDA	+305 days
19 Dec 2012	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes 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.

Product as listed by the FDA

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 electrocardiogram or vectorcardiogram.

Where it was distributed

Nationwide Distribution including CA, IL, MA, MN, and SD.

Nationwide California Illinois Massachusetts Minnesota South Dakota

Questions about this recall

Why was it recalled?

Which lots are affected?

Lots 202404, 202506, 203431,

Where was it sold?

Nationwide Distribution including CA, IL, MA, MN, and SD.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 61209

This product is part of a recall event; the main page for the event is Empi Stimc RE Self Adhesive electrodes recalled by Covidien.

Reported	Class	Recall	Company	Reason	Where
19 Dec 2012	CLASS II	Empi Stimc RE Self Adhesive electrodes recalled by Covidien	Covidien	Other	Nationwide
19 Dec 2012	CLASS II	Performa reusable and self-adhering Tens/Nmes/Fes recalled by Covidien	Covidien	Other	Nationwide
19 Dec 2012	CLASS II	Reusable, non-sterile, self-adhering electrodes for use recalled	Covidien	Other	Nationwide

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