Reported Mar 18, 2026 · Ongoing

PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code:…

Physio-Control, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Physio-Control, Inc. · 11811 Willows Rd Ne · Redmond, WA · 98052-2003

Is this the product you have?

  • PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator
  • Electrodes Catalog Numbers11101-000016
  • UDI-DI code00721902629013
  • Catalog Number11101-000017
  • UDI-DI code00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered
  • to the patient by a factor of 41. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs)
Lot codes and dates
  • Catalog Numbers11101-000016
  • UDI-DI code00721902629013
  • Catalog Number11101-000017
  • UDI-DI code00721902682483
  • Lot Numbers
    • 315303
    • 315639
    • 315858
    • 316007
    • 320529
    • 318931
Amount recalled
16,499 electrodes (US/OUS: 8327/8172)

Where it was sold

Why it was recalled

Due to pediatric defibrillator electrode delamination

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.