Reusable — Class II medical device recall Z-0499-2013
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-0499-2013 |
|---|---|
| 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 | 3,594 pouches |
| Lot numbers | 202404, 202506, 203431 |
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 electrocardiogram or vectorcardiogram.
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-0499-2013. 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.