Severity
Critical
FDA Devices recall · Reported October 22, 2014
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
Covidien LLC recalled Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, R… - a critical-severity action.
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, R… was recalled by Covidien LLC in October 22, 2014. Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model F…. Check the official notice for the remedy. Verify recall #Z-0043-2015 with the FDA Devices before acting.
The recall
Covidien LLC issued this critical-severity FDA Devices recall-Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model F….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0043-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0043-2015) was formally reported on October 22, 2014, with the manufacturer initiating the action on September 18, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Covidien LLC is listed as the recalling firm, operating out of Mansfield, MA. Federal records list the affected scope as 317,550 pairs.
The documented reason for this recall is: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators Distribution data in the federal record shows the product reached: Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Ch…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Critical
Affected scope
317,550 pairs
Related Recalls
6
3 from same agency
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0043-2015 |
| Date reported | October 22, 2014 |
| Date initiated | September 18, 2014 |
| Recalling firm | Covidien LLC |
| Firm location | Mansfield, MA |
| Affected scope | 317,550 pairs |
| Distribution | Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiw… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 22, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.