CLASS II ONGOING Device recall · Reported 17 Jul 2024 · FDA Enforcement Report
ZOLL Powerheart G5 AED, Semi-Automatic recalled by Zoll Medical
Zoll Medical is recalling ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator, distributed nationwide in the US. The recall was initiated on 31 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2324-2024
- FDA event ID
- 94792
- Recalling firm
- Zoll Medical, Deerfield, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 May 2024
- FDA classified
- 10 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Lead & Heavy Metals
- Device type
- Pacemakers & Defibrillators
Timeline
| 31 May 2024 | Recall initiated by company | |
| 10 Jul 2024 | Classified by FDA | +40 days |
| 17 Jul 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: 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
Where it was distributed
Nationwide including PR. Foreign: AU BM CA CH DE DK ES FR GB HK HU ID IE IL IT KR MA MT NL NO PR SA SE SI SN TR
Nationwide CaliforniaIllinoisMassachusettsMontanaPuerto Rico
Questions about this recall
Is ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator recalled?
Yes. Zoll Medical recalled ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator on 31 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-2324-2024.
Why was it recalled?
G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest
Which lots are affected?
GTIN: 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 Serial Number Range: D00000276194-D00000343449
Where was it sold?
Nationwide including PR. Foreign: AU BM CA CH DE DK ES FR GB HK HU ID IE IL IT KR MA MT NL NO PR SA SE SI SN TR
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zoll Medical
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ZOLL Powerheart G5 AED recalled by ZOLL Medical | ZOLL Medical | Temperature Abuse | Nationwide |
| Device | CLASS II | ZOLL Powerheart G5 AED recalled by ZOLL Medical | ZOLL Medical | Temperature Abuse | Nationwide |
| Device | CLASS II | ZOLL Powerheart G5 AED recalled by ZOLL Medical | ZOLL Medical | Temperature Abuse | Nationwide |
| Device | CLASS II | ZOLL Powerheart G5 AED recalled by ZOLL Medical | ZOLL Medical | Temperature Abuse | Nationwide |
| Device | CLASS I | ZOLL 731 Ventilator (EMV+, AEV, Eagle II) recalled by ZOLL Medical | ZOLL Medical | Other | Nationwide |
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