Reusable — Class II medical device recall Z-0498-2013
Terminated recall by Covidien LLC dba Uni-Patch, reported 2012-12-19, distributed nationwide. Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined
| Recall number | Z-0498-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC dba Uni-Patch, Wabasha, MN, United States |
| Recall initiated | 2012-02-09 |
| Classified | 2012-12-10 |
| Reported by FDA | 2012-12-19 |
| Terminated | 2013-01-03 |
| Distributed | Nationwide (US) |
| Quantity | 2,014 pouches |
| Lot numbers | 202028, 202722 |
Product
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0498-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.