ZOLL Powerheart G5 AED — Class II medical device recall Z-2324-2024
Ongoing recall by Zoll Medical Corporation, reported 2024-07-17, distributed nationwide. G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock
| Recall number | Z-2324-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zoll Medical Corporation, Deerfield, WI, United States |
| Recall initiated | 2024-05-31 |
| Classified | 2024-07-10 |
| Reported by FDA | 2024-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 14,885 |
| UPC / GTIN / UDI-DI | 00812394021239, 00812394021277, 00812394021284, 00812394021413, 00812394022779, 00847946038182, 00847946038199, 00847946038243, 00847946038250, 00847946038304, 00847946038328, 00847946038335, 00847946038342, 00847946038359, 00847946038380, 00847946038397, 00847946038403, 00847946038410, 00847946038434, 00847946038441, 00847946038496, 00847946038519, 00847946038533, 00847946038571, 00847946038588 and 7 more |
| Model numbers | G5S-00A, G5S-00A-TSO, G5S-00C, G5S-01A, G5S-02-L, G5S-02A, G5S-02C, G5S-04A, G5S-05A, G5S-05C, G5S-06A, G5S-06C, G5S-08A, G5S-08C, G5S-10A, G5S-10C, G5S-11A, G5S-11C, G5S-12C, G5S-13A, G5S-14A, G5S-15A, G5S-17A, G5S-17C, G5S-19A and 18 more |
Product
ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-00A-TSO G5S-00C G5S-01A G5S-02A G5S-02C G5S-02-L G5S-04A G5S-05A G5S-05C G5S-06A G5S-06C G5S-08A G5S-08C G5S-10A G5S-10C G5S-11A G5S-11C G5S-12C G5S-13A G5S-14A G5S-15A G5S-17A G5S-17C G5S-19A G5S-23C G5S-29A G5S-29C G5S-31A G5S-31A-SJA G5S-31C-SJA G5S-36A G5S-37A G5S-41A G5S-41C G5S-80A G5S-80A-TSO G5S-80C G5S-80-L G5S-82A G5S-82C G5S-83C G5S-90C
Reason for recall
G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest
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-2324-2024. 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.