Class II — Covidien LLC dba Uni-Patch
| Recalling firm | Covidien llc |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 | 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. |
| Quantity | 3594 pouches |
| Distribution | Nationwide Distribution including CA, IL, MA, MN, and SD. |
| Initiated | 2012-02-09 |
| Classified | 2012-12-10 |
| Terminated | 2013-01-03 |
| Recall number | Z-0499-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Covidien LLC dba Uni-Patch (Z-0499-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/61209/
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