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...
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.
About HeartSine Technologies Ltd
HeartSine Technologies Ltd has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report