FDA (Devices) recall action 96198

ZOLL Medical Corporation recalled 8 products on 2025-03-19

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2025-03-19
Critical: 0
Units: 141,166

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

HighFDA (Devices)··2025-03-19
ZOLL Powerheart G5 AED may fail self-test in extreme environments
ZOLL is recalling certain Powerheart G5 automated external defibrillators (AED) due to the potential for devices to fail their self-test when exposed to extreme temperatures or humidity.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as
Category
Distribution
17 states
HighFDA (Devices)··2025-03-19
ZOLL Powerheart G5 AED may fail self-test in extreme temperatures or humidity
ZOLL is recalling 73 Powerheart G5 AED units that may fail their internal self-test when exposed to extreme temperatures or humidity. Affected devices could be unreliable in emergencies.
Product
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 i
Category
Distribution
17 states
HighFDA (Devices)··2025-03-19
ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Environmental Conditions
ZOLL is recalling certain Powerheart G5 AED models that may fail their self-test function when exposed to extreme temperature or humidity. Affected devices might not function properly in emergencies.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The
Category
Distribution
17 states
HighFDA (Devices)··2025-03-19
ZOLL Powerheart G5 AED Self-Test May Fail Under Extreme Environmental Conditions
ZOLL is recalling certain Powerheart G5 AED units that may fail their self-test when exposed to extreme temperatures or humidity. The affected devices could fail to function properly in emergencies.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; Software Version: NA Product Description: The Powerheart G5 automa
Category
Distribution
17 states
HighFDA (Devices)··2025-03-19
ZOLL Powerheart G5 AED Devices Recalled for Self-Test Failure Risk
ZOLL is recalling 8,744 Powerheart G5 AED units that may fail their self-test if exposed to extreme temperatures or humidity, potentially masking device malfunctions.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrilla
Category
Distribution
17 states
HighFDA (Devices)··2025-03-19
ZOLL Powerheart G5 AED devices may fail self-test in extreme environments
ZOLL is recalling Powerheart G5 AED devices that may fail their self-test when exposed to extreme temperature or humidity, potentially affecting proper device operation.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrilla
Category
Distribution
17 states
HighFDA (Devices)··2025-03-19
ZOLL Powerheart G5 AED May Fail Self-Test After Environmental Exposure
ZOLL Powerheart G5 AED devices may fail their self-test if exposed to extreme temperatures or humidity. Approximately 56,981 units are being recalled nationwide and internationally.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as
Category
Distribution
17 states
HighFDA (Devices)··2025-03-19
ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Conditions
The ZOLL Powerheart G5 automated external defibrillator may fail its self-test after prolonged exposure to extreme temperatures or humidity levels. This could prevent proper device functioning in an emergency.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed
Category
Distribution
17 states