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 Recalled by HeartSine Technologies Ltd Due to Single use battery and electrode cartridge may be...

Date: April 26, 2023
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, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P

Quantity: 30,022 units

Why Was This Recalled?

Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.

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