Agency classClass IIOur severity:High FDA (Devices)·Z-1322-2025·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a life-critical medical device where no adverse events have been reported. The hazard is potential device self-test failure under extreme environmental conditions (temperature/humidity). This qualifies as high severity because the product is risk-of-harm (AED for cardiac emergencies), though no injuries have been reported.

Plain-English summary

ZOLL Medical Corporation is recalling specific Powerheart G5 AED units due to a self-test failure risk. The automated external defibrillator (AED) is designed to treat life-threatening cardiac arrhythmias during sudden cardiac arrest.

The devices have the potential to fail their self-test as a result of prolonged exposure to extreme environments, including extreme temperatures and/or humidity. This failure could prevent the device from operating properly if needed during a cardiac emergency.

The recalled units were distributed nationwide in the United States and to approximately 50 countries. Specific model numbers and serial numbers have been identified for affected devices.

Customers with affected units should contact ZOLL Medical Corporation. Users should verify their device's model and serial number against the official recall information to determine if their unit is affected.

The recalled product

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…
Manufacturer: ZOLL Medical Corporation
Category: Medical Device — Automated External Defibrillator
Hazard: self-test-failure
extreme-temperature
extreme-humidity
Affected units: 1,312

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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
UDI-DI: (1) no UDI
(2) 00812394021239
(3) no UDI
(4) no UDI
(5) no UDI
(6) no UDI
(7) no UDI
(8) 00812394021413
(9) no UDI
(10) no UDI

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Part of a larger recall action

This product is one of 8 recalled by ZOLL Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · ZOLL Medical Corporation

See all →

High
ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Environmental Conditions
FDA (Devices) · 2025-03-19
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ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Conditions
FDA (Devices) · 2025-03-19
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ZOLL Powerheart G5 AED May Fail Self-Test After Environmental Exposure
FDA (Devices) · 2025-03-19
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ZOLL Powerheart G5 AED devices may fail self-test in extreme environments
FDA (Devices) · 2025-03-19
High
ZOLL Powerheart G5 AED Devices Recalled for Self-Test Failure Risk
FDA (Devices) · 2025-03-19

Same hazard · self test failure