CLASS I Device recall · Reported 20 Dec 2017 · FDA Enforcement Report

Lifepak(R) defibrillation electrodes recalled by Physio-Control

Physio-Control is recalling Lifepak(R) defibrillation electrodes, distributed nationwide in the US. The recall was initiated on 27 Oct 2017 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes713609, 717912, 713904, 718033, 715008, 719323

Quantity recalled14,219 units in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0186-2018
FDA event ID: 78303
Recalling firm: Physio-Control, Redmond, WA
Classification: Class I
Status: Terminated
Recall initiated: 27 Oct 2017
FDA classified: 12 Dec 2017
Reported: 20 Dec 2017
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

27 Oct 2017	Recall initiated by company
12 Dec 2017	Classified by FDA	+46 days
20 Dec 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.

Product as listed by the FDA

LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.

Where it was distributed

Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia, China, Hong Kong, Japan, Argentina, Mexico, Norway, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and New Zealand.

Nationwide Puerto Rico

Questions about this recall

Is Lifepak(R) defibrillation electrodes recalled?

Yes. Physio-Control recalled Lifepak(R) defibrillation electrodes on 27 Oct 2017. The recall is Class I and its status is Terminated. Recall number Z-0186-2018.

Why was it recalled?

The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.

Which lots are affected?

713609, 717912, 713904, 718033, 715008, 719323

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Physio-Control

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13 May 2026Device	CLASS II	Lifepak 15, REF: 99577-000025, 99577 recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
18 Mar 2026Device	CLASS II	Physio Control Infant/Child Reduced Energy Defibrillator Electrodes recalled	Physio-Control	Other	Nationwide
10 Sep 2025Device	CLASS II	Lifepak 1000 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
10 Sep 2025Device	CLASS II	Lifepak 15 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
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