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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Monitoring Devices

LIFEPAK 20e Defibrillator/Monitor Recalled for Incorrect Keypad Installation

Agency Publication Date: February 25, 2025
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Summary

This recall affects one LIFEPAK 20e Defibrillator/Monitor (REF 99507-000001) because an incorrect keypad was installed on the device during manufacturing. The incorrect keypad could lead to confusion or operational errors when using the device to treat patients in cardiopulmonary arrest. No incidents or injuries have been reported, and the manufacturer is coordinating with the affected facility to correct the issue.

Risk

The incorrect keypad may prevent a healthcare provider from correctly operating the defibrillator during a cardiac emergency. Any delay or error in therapy for a patient in cardiopulmonary arrest poses a high risk of serious injury or death.

What You Should Do

  1. This recall affects a single LIFEPAK 20e Defibrillator/Monitor, model/catalog number 99507-000001, with Serial Number 38289467 and UDI-DI code 00883873813751.
  2. Stop using the recalled device. Contact the manufacturer, Physio-Control, Inc., or your equipment distributor immediately to arrange for a return, replacement, or on-site correction of the keypad.
  3. If you have additional questions regarding this recall, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: LIFEPAK 20e Defibrillator/Monitor
Model / REF:
99507-000001
Serial Numbers:
38289467
UDI:
00883873813751

The AED mode is to be used only on patients in cardiopulmonary arrest.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96095
Status: Active
Manufacturer: Physio-Control, Inc.
Manufactured In: United States
Units Affected: 1
Distributed To: West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.