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FDAJune 30, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

heartsine technologiesheartsine

UPCs

05060167120670506016712068050601671206905060167120700506016712804205060167128060506016712808

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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