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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

Zoll Medical Corporation: Powerheart G5 AEDs Recalled Due to Protective Film Blocking Shock Button

Agency Publication Date: July 10, 2024
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Summary

Zoll Medical Corporation is recalling approximately 14,885 Powerheart G5 Semi-Automatic AEDs because a clear protective film used for shipping may still be attached to the device's front panel. If this film is not removed during setup, it can prevent the user from successfully pressing the shock button during a medical emergency. This recall affects the G5Sxxx family of automated external defibrillators (AEDs) distributed nationwide and internationally. Consumers should immediately check their devices to ensure no plastic film is covering the buttons or screen.

Risk

The presence of the protective shipping film can physically obstruct the shock button, preventing it from being activated. This may cause a critical delay or a total failure to deliver life-saving defibrillation therapy to a person suffering from sudden cardiac arrest, which can lead to permanent injury or death.

What You Should Do

  1. Locate your ZOLL Powerheart G5 Semi-Automatic AED and check the front panel for a clear, adhesive protective film covering the screen and shock button.
  2. Identify your device by checking the Model or Catalog number on the label; affected models include G5S-00A, G5S-01A, G5S-02A, G5S-05A, G5S-10A, G5S-11A, G5S-12C, and others in the G5Sxxx family with serial numbers between D00000276194 and D00000343449.
  3. If the clear plastic film is present, peel it off immediately and discard it to ensure the shock button is fully accessible for emergency use.
  4. Verify the GTIN on your device packaging matches one of the affected codes, such as 00812394021239, 00812394021277, 00847946038182, or 00847946039127.
  5. Contact your healthcare provider or Zoll Medical Corporation at 500 Burdick Pkwy, Deerfield, WI 53531 for further instructions regarding the safe deployment of your device.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Remove protective shipping film and contact manufacturer for instructions.

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

Affected Products

Product: ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family
Model / REF:
G5S-00A
G5S-00A-TSO
G5S-00C
G5S-01A
G5S-02A
G5S-02C
G5S-02-L
G5S-04A
G5S-05A
G5S-05C
G5S-06A
G5S-06C
G5S-08A
G5S-08C
G5S-10A
G5S-10C
G5S-11A
G5S-11C
G5S-12C
G5S-13A
G5S-14A
G5S-15A
G5S-17A
G5S-17C
G5S-19A
G5S-23C
G5S-29A
G5S-29C
G5S-31A
G5S-31A-SJA
G5S-31C-SJA
G5S-36A
G5S-37A
G5S-41A
G5S-41C
G5S-80A
G5S-80A-TSO
G5S-80C
G5S-80-L
G5S-82A
G5S-82C
G5S-83C
G5S-90C
UPC Codes:
00812394021239
00812394021277
00812394021284
00812394021413
00812394022779
00847946038182
00847946038199
00847946038243
00847946038250
00847946038304
00847946038328
00847946038335
00847946038342
00847946038359
00847946038380
00847946038397
00847946038403
00847946038410
00847946038434
00847946038441
00847946038496
00847946038519
00847946038533
00847946038571
00847946038588
00847946038663
00847946038816
00847946038830
00847946039028
00847946039035
00847946039066
00847946039127
Lot Numbers:
Serial Number Range: D00000276194-D00000343449

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94792
Status: Active
Manufacturer: Zoll Medical Corporation
Manufactured In: United States
Units Affected: 14885
Distributed To: Nationwide

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.