FDA Device recall Z-3270-2026
HeartSine samaritan PAD (Public Access Defibrillator)
- FDA Device
- Class III
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class III recall of HeartSine samaritan PAD (Public Access Defibrillator) by Heartsine Technologies, citing products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3270-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-07-27 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Heartsine Technologies |
| Distribution | US |
Product
HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069
Reason
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
Identifiers
| code_info | Product - 350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers: 24…Product - 350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers: 24D98056051D24 24D98057467D24 24D98057468D24 24D98057469D24 24D98068091E24 24D98068097E24 24D98070022F24 24D98070023F24 24D98070024F24 24D98070025F24 24D98070026F24 24D98070027F24 24D98070028F24 24D98070029F24 24D98070030F24 24D98070031F24 24D98070032F24 24D98070033F24 24D98070034F24 24D98070035F24 24D98070036F24 24D98070037F24 24D98070038F24 24D98070040F24 24D98070041F24 24D98070042F24 24D98070043F24 24D98070046F24 24D98070047F24 24D98070048F24 24D98070049F24 24D98070050F24 24D98070051F24 24D98070052F24 24D98070053F24 24D98070054F24 24D98070055F24 24D98070056F24 24D98070057F24 24D98070058F24 24D98070060F24 24D98070061F24 24D98070062F24 24D98070063F24 24D98070064F24 24D98070065F24 24D98070066F24 24D98070068F24 24D98070069F24 24D98070071F24 24D98070072F24 24D98070074F24 24D98070075F24 24D98070076F24 24D98070077F24 24D98070078F24 24D98070079F24 24D98070080F24 24D98070081F2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Heartsine Technologies
- HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Mi…
FDA Device · Class II · 2026-09-16 · Heartsine Technologies - HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
FDA Device · Class II · 2025-10-29 · Heartsine Technologies - HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
FDA Device · Class II · 2025-08-06 · Heartsine Technologies - HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
FDA Device · Class II · 2024-05-22 · Heartsine Technologies - HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10
FDA Device · Class II · 2024-02-21 · Heartsine Technologies
All Heartsine Technologies recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3270-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.