Agency classClass IIOur severity:High FDA (Devices)·Z-1317-2025·Announced 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.

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: This is an FDA Class II medical device recall affecting a life-critical product (automated external defibrillator) where a potential malfunction (self-test failure) could lead to patient harm if the device fails to operate during a cardiac emergency. No actual illnesses or injuries are reported, but the risk-of-harm nature of the product warrants a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ZOLL Medical Corporation is recalling approximately 56,981 units of the Powerheart G5 automated external defibrillator (AED). The recalled devices are models G5A-80A and G5A-80A-TSO, distributed nationwide in the United States and internationally.

The devices may fail their self-test function if exposed to prolonged extreme temperatures or humidity. A self-test failure could prevent the AED from functioning properly during a cardiac emergency.

Users of these devices should verify proper storage conditions and monitor device performance to ensure reliable operation when needed.

The recalled product

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…
Manufacturer: ZOLL Medical Corporation
Category: Medical Device — Defibrillator
Hazard: device-malfunction
self-test-failure
environmental-exposure
Affected units: 56,981

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) G5A-80A
(2) G5A-80A-TSO
UDI-DI: (1) 00812394021192
(2) 00812394021390
Serial Numbers: D00000003715
D00000003785
D00000003909
D00000003916
D00000003920
D00000003937
D00000003940
D00000003946
D00000003948
D00000003953
D00000003969
D00000003975
D00000004007
D00000004008
D00000004009
D00000004010

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
High
ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Conditions
FDA (Devices) · 2025-03-19
High
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
High
ZOLL Powerheart G5 AED Self-Test May Fail Under Extreme Environmental Conditions
FDA (Devices) · 2025-03-19

Same hazard · device malfunction