The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1319-2025·Announced 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.

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 with no reported illnesses, injuries, or deaths. The hazard is theoretical—potential for self-test failure under extreme environmental conditions—and constitutes a risk-of-harm product without reported adverse events, corresponding to severity score 3.

Plain-English summary

ZOLL Medical Corporation is recalling certain Powerheart G5 automated external defibrillator (AED) models that may fail their self-test function when exposed to prolonged extreme environmental conditions, including extreme temperatures and high humidity.

The affected devices are twelve specific model variants (G5A-01C, G5A-02C, G5A-05C, G5A-08C, G5A-10C, G5A-13C, G5A-15C, G5A-22C, G5A-41C, G5A-85C, G5A-90C, and G5A-80-L). Approximately 960 units were distributed across the United States and internationally.

A failed self-test may leave users unaware that the device is not functioning, creating a risk that the AED will not operate properly in a cardiac emergency. Users with affected devices should contact ZOLL Medical Corporation and reference FDA recall Z-1319-2025 to determine if their specific device serial number is included and to inquire about corrective actions.

The recalled product

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…
Manufacturer
ZOLL Medical Corporation
Category
Medical Device — Cardiac Defibrillator
Hazard
Affected units
960

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-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
  • UDI-DI: (1) 00812394021161
  • (2) no UDI
  • (3) no UDI
  • (4) no UDI
  • (5) no UDI
  • (6) no UDI
  • (7) no UDI
  • (8) no UDI
  • (9) 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 →

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