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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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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Physio-Control LIFEPAK Defibrillators Recalled for Missed Service Inspections

Agency Publication Date: September 2, 2025
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Summary

Physio-Control, Inc. has recalled 8 LIFEPAK 15, LIFEPAK 1000, and LIFEPAK CR2 defibrillators because required safety inspections were not performed after the devices underwent servicing. Approximately 8 units are affected by this recall. Without these final inspections, there is no assurance that the devices were properly reassembled or that all components are functioning according to specifications.

Risk

If a defibrillator has a hidden defect or was incorrectly serviced, it may fail to deliver life-saving electrical shocks or provide accurate monitoring during a cardiac emergency. This failure could result in serious injury or death for a patient in need of immediate resuscitation.

What You Should Do

  1. This recall affects specific LIFEPAK 15, LIFEPAK 1000, and LIFEPAK CR2 defibrillators that were recently serviced and returned to customers in Colorado and Montana.
  2. Identify your device by checking the model name and serial number printed on the product label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately. Contact Physio-Control, Inc. or your authorized distributor to arrange for a proper inspection, return, or replacement of the affected unit.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 with any additional questions regarding this recall.

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 15 Defibrillator/Monitor
Model / REF:
99577-001957
99577-000046
99577-000093
99577-001256
Serial Numbers:
49085553
38154524
39059475
40973093
UDI:
883873871690
883873988022
883873979020
883873911631

Intended for use by trained medical personnel in indoor and outdoor emergency settings.

Product: LIFEPAK 1000 Defibrillator
Model / REF:
99425-000025
Serial Numbers:
35942190
41012118
48988273
UDI:
885074698953

Automated External Defibrillator (AED) for use on patients in cardiopulmonary arrest.

Product: LIFEPAK CR2 Defibrillator
Model / REF:
99512-001434
Serial Numbers:
49638156
UDI:
883873785911

Includes cprCOACH Feedback Technology for CPR guidance.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96949
Status: Active
Manufacturer: Physio-Control, Inc.
Manufactured In: United States
Units Affected: 3 products (4 units; 3 units; 1 unit)
Distributed To: Colorado, Montana

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.