HeartSine SAM 350P — Class II medical device recall Z-2174-2025
Ongoing recall by HeartSine Technologies Ltd, reported 2025-08-06, distributed nationwide. Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver sh
| Recall number | Z-2174-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartSine Technologies Ltd, Belfast, United Kingdom |
| Recall initiated | 2025-06-30 |
| Classified | 2025-07-25 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CA, CL, CO, CR, GB, HK, ID, IE, IL, JP, KR, MX, MY, NL, NZ, PH, PL, SG, TH, TW |
| Quantity | 190,516 units |
| UPC / GTIN / UDI-DI | 00506016712062, 00506016712086, 00506016712093, 00506016712147, 00506016712154, 00506016712178, 00506016712208, 00506016712239, 00506016712246, 00506016712260, 00506016712284, 00506016712529, 00506016712543, 00506016712635, 00506016712802, 00506016712970, 00506016712994, 05060167120008, 05060167120022, 05060167120039, 05060167120046, 05060167120060, 05060167120077, 05060167120114, 05060167120121 and 132 more |
| Serial numbers | 006122D23, 026956F24, 0506016712054, 0506016712060, 0506016712062, 0506016712064, 0506016712067, 0506016712068, 0506016712069, 0506016712070, 0506016712071, 0506016712072, 0506016712077, 0506016712083, 0506016712084, 0506016712086, 0506016712088, 0506016712090, 0506016712091, 0506016712092, 0506016712094, 0506016712095, 0506016712096, 0506016712128, 0506016712170 and 475 more |
| Model numbers | 350-STR-US-10, 350-STR-US-AV, 350-STR-US-GW, 350P, 360-STR-US-10, 360-STR-US-GW, 360P, 450-STR-US-10, 450-STR-US-GW, 450P |
Product
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Reason for recall
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
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-2174-2025. 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.