RegWardenFDA facility compliance records
Recall

Class II — Covidien LLC

Recalling firmCovidien llc
Registered facilityView this company's 22 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonMulti-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns
ProductMediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
Quantity114,000 sets
DistributionNationwide Foreign: Canada Australia Denmark Germany New Zealand
Initiated2015-08-19
Classified2015-09-02
Terminated2017-05-24
Recall numberZ-2546-2015
InitiationVoluntary: 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 (Z-2546-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71963/

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