HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07 recall — FDA Z-0288-2026
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
Overview of recall records associated with HeartSine Technologies Ltd, including dates, categories and classifications where available.
Classification mix: Class II: 4.
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual…
Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to…
This page summarizes recall records in which the official source identifies HeartSine Technologies Ltd as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.