The Recall Desk
HighFDA (Devices)·Z-1321-2025·Announced 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.

What this means for you

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 recall of a critical life-saving device where potential self-test failure could prevent emergency treatment of cardiac arrhythmias. No illnesses or injuries have been reported. The hazard is theoretical with no reported harm on a high-risk product, which per the rubric rates as High (3).

Plain-English summary

ZOLL Medical Corporation is recalling 7,221 Powerheart G5 AED devices (Model G5S-80C). The devices may fail their self-test following prolonged exposure to extreme environmental conditions, specifically extreme temperature and/or humidity.

The self-test function is critical—it verifies that the AED is operating properly before use in treating life-threatening heart rhythms such as ventricular fibrillation. A failed self-test could prevent the device from functioning when needed in an emergency.

The recall affects devices distributed nationwide and in multiple countries internationally. Users should verify that their devices are functioning properly and should contact ZOLL Medical Corporation if they have concerns about their device's status or need guidance on replacement or repair options.

The recalled product

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
Manufacturer
ZOLL Medical Corporation
Category
Medical Device — Automated External Defibrillator
Hazard
Affected units
7,221

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: G5S-80C
  • UDI-DI: 00812394021284
  • Serial Numbers: D00000171086
  • D00000171087
  • D00000171088
  • D00000171089
  • D00000171090
  • D00000171092
  • D00000171093
  • D00000171094
  • D00000171095
  • D00000171096
  • D00000171097
  • D00000171098
  • D00000171099
  • D00000171100
  • D00000171101
  • D00000171102
  • D00000171103
  • D00000171105

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 →

Related recalls

Same manufacturer · ZOLL Medical Corporation

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Same hazard · self test failure

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