HeartSine samaritan PAD — Class II medical device recall Z-1820-2024
Ongoing recall by HeartSine Technologies Ltd, reported 2024-05-22, distributed nationwide. Automated external defibrillators have a manufacturing issue that could prevent the device from delivering ins
| Recall number | Z-1820-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartSine Technologies Ltd, Belfast, N/A, United Kingdom |
| Recall initiated | 2024-04-08 |
| Classified | 2024-05-14 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 183,248 |
| UPC / GTIN / UDI-DI | 05060167120671, 05060167120688, 05060167120695, 05060167120701, 05060167120718, 05060167120725, 05060167120893, 05060167120909, 05060167120916, 05060167121371, 05060167121630, 05060167122071, 05060167122330, 05060167122491, 05060167122514, 05060167125379, 05060167125720, 05060167128042, 05060167128066, 05060167128080 |
| Model numbers | 8-DIGIT |
Product
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Reason for recall
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
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-1820-2024. 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.