Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: — Class II medical device recall Z-1316-2025
Ongoing recall by ZOLL Medical Corporation, reported 2025-03-19, distributed nationwide. The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (t
| Recall number | Z-1316-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ZOLL Medical Corporation, Chelmsford, MA, United States |
| Recall initiated | 2025-02-13 |
| Classified | 2025-03-12 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 2,268 units |
| UPC / GTIN / UDI-DI | 00812394021154, 00812394021192, 00812394021390, 00812394022243 |
| Serial numbers | D00000003482, D00000003546, D00000003557, D00000003600, D00000003625, D00000003783, D00000003978, D00000003983, D00000003985, D00000004036, D00000004037, D00000004040, D00000004043, D00000004089, D00000004098, D00000004100, D00000004105, D00000004107, D00000004109, D00000004111, D00000004116, D00000004118, D00000004119, D00000004120, D00000004123 and 475 more |
| Model numbers | 00812394021154, 00812394021192, 00812394021390, 00812394022243, G5A-00A, G5A-01A, G5A-02A, G5A-03A, G5A-19A, G5A-80A, G5A-80A-TSO |
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) 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 as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
Reason for recall
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1316-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.