Z-0500-2013Class II

Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an...

Name: Z-0500-2013 Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an...
Creator: Covidien LLC dba Uni-Patch
Published: 2012-02-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-02-09 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC dba Uni-Patch began a recall of 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... on 2012-02-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0500-2013
Classification: Class II
Status: Terminated
Initiated: 2012-02-09
Posted: 2012-12-10
Terminated: 2013-01-03
Recalling firm: Medtronic, Inc.
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.
Product code: GXY Electrode, Cutaneous
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Covidien sent An Urgent Product Recall letter, dated February 9, 2012, to all affected consignees. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the affected product if found. The letter asked customers to fill in teh quantity remaining in their inventory and fax it to 651-565-5888. A Covidien Customer Service rep would contact the consignee for returning product. Consignees were also requested to notify their customers of the recall. For questions regarding this recall call 508-261-8532.
Quantity in commerce: 3290
Distribution: Nationwide Distribution including CA, IL, MA, MN, and SD.
Product codes and lots: Lot 202406

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0500-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0498-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-10
Z-0499-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-10
Z-0500-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-10
Z-0501-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-10

Product code GXY

K915333Class IIElectrode Using Promeon Rg-60 Series GelLabeltape Meditect, Inc. / cleared 1992-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)