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Physio-Control, Inc.

Physio-Control, Inc. Recalls

All product recalls associated with Physio-Control, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Jul 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 48 recalls

Physio-Control, Inc.: PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx T...

Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

FDAJan 14, 2021Nationwide• Physio-Control, Inc.

Physio-Control, Inc.: Infant Child Starter Kits, Part Number: 3202784-009, con...

Packaging of infant child reduced energy electrodes was not properly sealed.

FDAApr 24, 2020Nationwide• Physio-Control, Inc.

Physio-Control, Inc.: Infant/Child Reduced Energy Defibrillation Electrodes, Pa...

Packaging of infant child reduced energy electrodes was not properly sealed.

FDAApr 24, 2020Nationwide• Physio-Control, Inc.

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Physio-Control, Inc.: LifePAK 500 Automated External Defibrillator, model numbe...

Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment

FDAMar 20, 2020Nationwide• Physio-Control, Inc.

Physio-Control, Inc.: LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufact...

Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.

FDADec 20, 2019Nationwide• Physio-Control, Inc.

Physio Control, Inc.: Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 1...

Laceration Risk

Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, Branford, Connecticut who is recalling the modules. The NIBP modules may be susceptible to sudden changes in cuff pressure. Sudden changes in cuff pressure may possibly be caused by bumping or squeezing the cuff. In some instances this may result in a screen display

FDAAug 12, 2009Nationwide• Physio Control, Inc.

Physio Control, Inc.: Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Mo...

The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.

FDAJul 31, 2009MN, DC• Physio Control, Inc.

Physio Control, Inc.: Biphasic LIFEPAK 12 defibrillator / monitor.

Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contribute to the death of a viable patient.

FDAMar 31, 2009PR• Physio Control, Inc.

Physio Control, Inc.: Internal Sterilizable Paddles (electrodes) and Handles wi...

Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.

FDAFeb 16, 2009Nationwide• Physio Control, Inc.

Physio Control, Inc.: The LIFEPAK 20 defibrillator/monitor is an AC powered ext...

When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform.

FDADec 30, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: External Sterilizable Paddles for use with the LIFEPAK 9,...

Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments.

FDANov 17, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: Pediatric Paddles attachments used with LIFEPAK 9, LIFEPA...

Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments.

FDANov 17, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: LIFEPAK CR Plus Automated External Defibrillator. Device ...

This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device. Fully automatic defibrillators h

FDAAug 28, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: LIFEPAK CR Plus Automated External Defibrillator (AED). ...

The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.

FDAJul 24, 2008PR• Physio Control, Inc.

Physio Control, Inc.: LIFEPAK Express Automated External Defibrillator (AED). ...

The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.

FDAJul 24, 2008PR• Physio Control, Inc.

Physio Control, Inc.: Physio-Control Lifepak 20 defibrillator/monitor is intend...

Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.

FDAJun 18, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: Keypad replacement for LIFEPAK20 or LIFEPAK20e. This pro...

A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.

FDAMay 13, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: Physio-Control LIFEPAK 20e defibrillator/monitor. This p...

FDAMay 13, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: Physio-Control LIFEPAK 20 defibrillator/monitor. This pr...

A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.

FDAMay 13, 2008Nationwide• Physio Control, Inc.

Physio Control, Inc.: Physio-Control LIFEPAK 12 defibrillator/monitor. The LIF...

The LIFEPAK12 defibrillator/monitor series (LP12) contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock.

FDAMay 8, 2008Nationwide• Physio Control, Inc.