CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report

ZOLL Powerheart G5 AED recalled by ZOLL Medical

ZOLL Medical is recalling ZOLL Powerheart G5 AED, distributed nationwide in the US. The recall was initiated on 13 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; UDI-DI: (1) 00812394021246, (2) no UDI, (3) no UDI, (4) no UDI; Serial Numbers: (1) D00000089561, D00000089566, D00000089577, D00000105587, D00000111542, D00000111556, D00000111640, D00000111706, D00000111718, D00000113136, D00000113147, D00000113175, D00000113177, D00000113178, D00000113180, D00000113181, D00000113182, D00000113199, D00000113200, D00000113201, D00000113205, D00000113206, D00000113207, D00000134850, D00000134892, D00000135125, D00000136870, D00000136917, D00000136954, D00000157288, D00000170036, D00000170073, D00000172554, D00000178309, D00000178332, D00000183632, D00000191330, D00000191339, D00000191347, D00000191349, D00000191362, D00000191363, D00000191366, D00000221153, D00000221179, D00000221199, D00000221200, D00000221206, D00000221208, D00000221211, D00000221235, D00000221237, D00000221245, D00000221247, D00000221257, D00000221263, D00000221265, D00000221267, D00000221273, D00000221279, D00000221283, (2)D00000004566, D00000004687, D00000004688, D00000005214, D00000017929, D00000067528, D00000067585, D00000067595, D00000067685, D00000155123, (3) D00000171086, (4) M00000005364;

Quantity recalled73 units

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-1320-2025
FDA event ID: 96198
Recalling firm: ZOLL Medical, Chelmsford, MA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Feb 2025
FDA classified: 12 Mar 2025
Reported: 19 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Pacemakers & Defibrillators

Timeline

13 Feb 2025	Recall initiated by company
12 Mar 2025	Classified by FDA	+27 days
19 Mar 2025	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

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

Where it was distributed

Domestic: Nationwide Distribution International: AE, AI, AM, AR, AT, AU, BD, BE, BG, BH, BM, BN, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GH, GU, HK, HR, HU, ID, IE, IL, IN, IS, IT, JE, JM, JP, KR, KW, KZ, LB, LT, MA, MC, MD, ME, MQ, MS, MT, MX, MY, NC, NG, NL, NO, NZ, OM, PA, PE, PG, PH, PK, PL, PR, PT, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, SM, TC, TH, TN, TR, TW, UA, US, VG, ZA.

Nationwide Arkansas California Colorado Delaware Idaho Illinois Indiana Massachusetts Maryland Maine Mississippi Montana North Carolina Pennsylvania Puerto Rico Tennessee

Questions about this recall

Is ZOLL Powerheart G5 AED recalled?

Yes. ZOLL Medical recalled ZOLL Powerheart G5 AED on 13 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1320-2025.

Why was it recalled?

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Which lots are affected?

Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; UDI-DI: (1) 00812394021246, (2) no UDI, (3) no UDI, (4) no UDI; Serial Numbers: (1) D00000089561, D00000089566, D00000089577, D00000105587, D00000111542, D00000111556, D00000111640, D00000111706, D00000111718, D00000113136, D00000113147, D00000113175, D00000113177, D00000113178, D00000113180, D00000113181, D00000113182, D00000113199, D00000113200, D00000113201, D00000113205, D00000113206, D00000113207, D00000134850, D00000134892, D00000135125, D00000136870, D00000136917, D00000136954, D00000157288, D00000170036, D00000170073, D00000172554, D00000178309, D00000178332, D00000183632, D00000191330, D00000191339, D00000191347, D00000191349, D00000191362, D00000191363, D00000191366, D00000221153, D00000221179, D00000221199, D00000221200, D00000221206, D00000221208, D00000221211, D00000221235, D00000221237, D00000221245, D00000221247, D00000221257, D00000221263, D00000221265, D00000221267, D00000221273, D00000221279, D00000221283, (2)D00000004566, D00000004687, D00000004688, D00000005214, D00000017929, D00000067528, D00000067585, D00000067595, D00000067685, D00000155123, (3) D00000171086, (4) M00000005364;

Where was it sold?

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
19 Mar 2025Device	CLASS II	ZOLL Powerheart G5 AED recalled by ZOLL Medical	ZOLL Medical	Temperature Abuse	Nationwide
19 Mar 2025Device	CLASS II	ZOLL Powerheart G5 AED recalled by ZOLL Medical	ZOLL Medical	Temperature Abuse	Nationwide
19 Mar 2025Device	CLASS II	ZOLL Powerheart G5 AED recalled by ZOLL Medical	ZOLL Medical	Temperature Abuse	Nationwide
17 Jul 2024Device	CLASS II	ZOLL Powerheart G5 AED, Semi-Automatic recalled by Zoll Medical	Zoll Medical	Lead & Heavy Metals	Nationwide
26 Jun 2024Device	CLASS I	ZOLL 731 Ventilator (EMV+, AEV, Eagle II) recalled by ZOLL Medical	ZOLL Medical	Other	Nationwide

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