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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

Physio-Control, Inc.: LIFEPAK 15 Defibrillators Recalled for Potential Battery Power Failure

Agency Publication Date: November 14, 2023
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Summary

Physio-Control, Inc. is recalling 32 units of the LIFEPAK 15 defibrillator/monitor because the battery pins inside the device can become loose. This mechanical defect can cause the device to lose power or fail to operate during a medical emergency. The affected units include various model configurations (REF numbers) sold across five U.S. states. Consumers and medical facilities should check their device serial numbers immediately to determine if their life-saving equipment is affected and contact the manufacturer for a resolution.

Risk

If the battery pins become loose, the defibrillator may not receive consistent power, which can lead to the device shutting down or failing to deliver a life-saving shock during cardiac arrest. This failure to operate during a critical emergency could result in serious injury or death.

What You Should Do

  1. Check the back of your LIFEPAK 15 device for the REF (model) number and Serial Number to see if it matches any of the 32 affected units.
  2. Verify if your unit's serial number is included: 38370274, 38290540, 38291328, 38315311, 38315314, 38324196, 38324199, 38332345, 38898631, 38166543, 40644322, 40644323, 40644331, 42221204, 42934131, 49618486, 44174756, 46013280, 46966395, 48149013, 46687975, 43393466, 44142362, 44739628, 44742060, 47821623, 49025144, 49663485, 49887344, 48839976, 48433670, or 48744028.
  3. Contact Physio-Control, Inc. or your healthcare provider immediately to discuss the defect and arrange for the necessary inspection or repair.
  4. Follow any specific instructions provided in the manufacturer's notification letter sent on September 29, 2023.
  5. Report any device failures or power issues to the FDA's MedWatch program.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for repair or replacement instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: LIFEPAK 15 (REF: 99577-000046)
Model / REF:
99577-000046
V15-2-000051
UPC Codes:
00883873988022
Lot Numbers:
Serial number: 38370274
Product: LIFEPAK 15 (REF: 99577-000055)
Model / REF:
99577-000055
V15-2-000061
UPC Codes:
00883873979426
Lot Numbers:
Serial numbers: 38290540, 38291328, 38315311, 38315314, 38324196, 38324199, 38332345, 38898631
Product: LIFEPAK 15 (REF: 99577-000061)
Model / REF:
99577-000061
V15-2-000067
UPC Codes:
00883873979358
Lot Numbers:
Serial number: 38166543
Product: LIFEPAK 15 (REF: 99577-001255)
Model / REF:
99577-001255
V15-2-001602
UPC Codes:
00883873911648
Lot Numbers:
Serial numbers: 40644322, 40644323, 40644331, 42221204, 42934131
Product: LIFEPAK 15 (REF: 99577-001373)
Model / REF:
99577-001373
V15-7-000002
UPC Codes:
00883873884331
Lot Numbers:
Serial number: 49618486
Product: LIFEPAK 15 (REF: 99577-001955)
Model / REF:
99577-001955
V15-5-000584
V15-7-000020
UPC Codes:
00883873871713
Lot Numbers:
Serial numbers: 44174756, 46013280, 46966395, 48149013
Product: LIFEPAK 15 (REF: 99577-001956)
Model / REF:
99577-001956
V15-7-000021
UPC Codes:
00883873871706
Lot Numbers:
Serial number: 46687975
Product: LIFEPAK 15 (REF: 99577-001957)
Model / REF:
99577-001957
V15-5-000586
V15-7-000022
UPC Codes:
00883873871690
Lot Numbers:
Serial numbers: 43393466, 44142362, 44739628, 44742060, 47821623, 49025144, 49663485, 49887344
Product: LIFEPAK 15 (REF: 99577-001958)
Model / REF:
99577-001958
V15-7-000023
UPC Codes:
00883873871683
Lot Numbers:
Serial number: 48839976
Product: LIFEPAK 15 (REF: 99577-001960)
Model / REF:
99577-001960
V15-7-000026
UPC Codes:
00883873871669
Lot Numbers:
Serial numbers: 48433670, 48744028

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93233
Status: Active
Manufacturer: Physio-Control, Inc.
Sold By: Authorized Medical Distributors; Direct Sales
Manufactured In: United States
Units Affected: 10 products (1 unit; 8 yrs.; 1 unit; 5 units; 1 unit; 4 units; 1 units; 8 units; 1 unit; 2 units)
Distributed To: Arizona, California, North Carolina, New Jersey, New York

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.

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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.