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.
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 life-critical medical device with potential self-test failures. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High. No illnesses or injuries have been reported.
Plain-English summary
ZOLL Medical Corporation is recalling 8,744 units of the Powerheart G5 automated external defibrillator (AED), Model G5S-80A. This device is designed to treat life-threatening heart rhythms such as ventricular fibrillation by detecting abnormal cardiac rhythms and delivering an electrical shock.
The recalled devices have the potential to fail their self-test function if exposed to prolonged extreme temperatures or humidity. The self-test is an important diagnostic feature that verifies the device is operating properly. If the self-test fails to function, users cannot confirm the device's operational status.
The affected units were distributed domestically throughout the United States and internationally to numerous countries.
The recalled product
- 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
- Manufacturer
- ZOLL Medical Corporation
- Hazard
- self-test-failure
- environmental-sensitivity
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-80A
- UDI-DI: 00812394021277
- Serial Numbers: D00000003974
- D00000004048
- D00000004128
- D00000004404
- D00000004436
- D00000004556
- D00000004560
- D00000004563
- D00000004564
- D00000004573
- D00000004581
- D00000004582
- D00000004642
- D00000004665
- D00000004666
- D00000004718
- D00000004730
- D00000004736
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- Moderateda Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Introducer Kit 14Fr heart pump safety recall
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22