Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006

Recall Insight

This FDA Devices action (record #Z-0046-2015) 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 indicate 133,930 pairs units are affected, a scale large enough to require multi-state distribution tracking.

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 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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.