Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HeartSine SAM 350P Recalled by HeartSine Technologies Ltd Due to Due to a component manufacturing issue, Automated External...

Date: June 30, 2025
Company: HeartSine Technologies Ltd
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact HeartSine Technologies Ltd directly.

Affected Products

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

Quantity: 190,516 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About HeartSine Technologies Ltd

HeartSine Technologies Ltd has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report