FDA Device recall Z-2174-2025

HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)

FDA Device
Class II
ongoing
Published 2025-08-06

On 2025-08-06 the FDA classified a Class II recall of HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator) by Heartsine Technologies, citing due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks).

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2174-2025
Classification	Class II
Status	ongoing
Initiated	2025-06-30
Published	2025-08-06
Last updated	2026-09-13 11:57 UTC
Company	Heartsine Technologies
Distribution	US

Product

HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)

Reason

Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)

Identifiers

code_info	U.S. Model 350P Item Number: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers 23D98002591E23 23D98002593E23 23D9… U.S. Model 350P Item Number: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers 23D98002591E23 23D98002593E23 23D98002594E23 23D98002595E23 23D98002597E23 23D98002608E23 23D98002638E23 23D98002668E23 23D98002669E23 23D98002699E23 23D98002734E23 23D98002751E23 23D98002755E23 23D98002756E23 23D98002758E23 23D98002760E23 23D98002761E23 23D98002765E23 23D98002772E23 23D98002773E23 23D98002774E23 23D98002845E23 23D98002852E23 23D98002853E23 23D98002855E23 23D98002856E23 23D98002857E23 23D98002858E23 23D98002859E23 23D98002877E23 23D98002879E23 23D98002885E23 23D98002887E23 23D98002987E23 23D98002989E23 23D98002990E23 23D98003083E23 23D98003092E23 23D98003117I23 23D98003118E23 23D98003459D23 23D98003475D23 23D98008368E23 23D98008390E23 23D98008877E23 23D98011224D23 23D98012987E23 23D98012991E23 23D98012993E23 23D98012994E23 23D98012998E23 23D98012999E23 23D98013490F23 23D98013500F23 23D98016785E23 23D98017244E23 23D98020031C23 23D98020033C23 23D98020036C23 23D98020351C23 23D98020356C23

code_info

U.S. Model 350P Item Number: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers 23D98002591E23 23D98002593E23 23D9…

U.S. Model 350P Item Number: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers 23D98002591E23 23D98002593E23 23D98002594E23 23D98002595E23 23D98002597E23 23D98002608E23 23D98002638E23 23D98002668E23 23D98002669E23 23D98002699E23 23D98002734E23 23D98002751E23 23D98002755E23 23D98002756E23 23D98002758E23 23D98002760E23 23D98002761E23 23D98002765E23 23D98002772E23 23D98002773E23 23D98002774E23 23D98002845E23 23D98002852E23 23D98002853E23 23D98002855E23 23D98002856E23 23D98002857E23 23D98002858E23 23D98002859E23 23D98002877E23 23D98002879E23 23D98002885E23 23D98002887E23 23D98002987E23 23D98002989E23 23D98002990E23 23D98003083E23 23D98003092E23 23D98003117I23 23D98003118E23 23D98003459D23 23D98003475D23 23D98008368E23 23D98008390E23 23D98008877E23 23D98011224D23 23D98012987E23 23D98012991E23 23D98012993E23 23D98012994E23 23D98012998E23 23D98012999E23 23D98013490F23 23D98013500F23 23D98016785E23 23D98017244E23 23D98020031C23 23D98020033C23 23D98020036C23 23D98020351C23 23D98020356C23

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2174-2025%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.