HeartSine Technologies recalled over 1.2 million defibrillator pads on September 18, 2025. The recall affects several models due to defective pins that may disrupt electrical contact. Consumers and healthcare providers should stop using these pads immediately.
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact HeartSine Technologies Ltd or your healthcare provider for instructions. Notification method: Letter
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The recall includes HeartSine Pad-Pak models: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, and PAD-PAK-04J. A total of 1,291,165 units were distributed across the U.S. and internationally.
Defective pins in the recalled defibrillator pads may disrupt the mechanical fit and electrical contact. This defect poses a high risk to patients relying on these devices for emergency cardiac care.
There have been customer complaints regarding the malfunction, but no specific injury or death counts were reported.
Stop using the affected defibrillator pads immediately. Follow the recall instructions provided by HeartSine Technologies and contact your healthcare provider for further guidance.
For more information, contact HeartSine Technologies Ltd. Visit their website or refer to the FDA notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0288-2026.
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