The Recall Desk

Manufacturer

HeartSine Technologies Ltd

6 recalls in our database name HeartSine Technologies Ltd as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2025-10-29

Of the 6 recalls from HeartSine Technologies Ltd we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-0288-2026·2025-10-29

    Defibrillator pad packs recalled over damaged pins disrupting electrical contact

    HeartSine Technologies is recalling 1,291,165 Pad-Pak units because defibrillator pads may contain damaged pins that disrupt the mechanical fit and electrical contact.

    Product
    HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2025·2025-08-06

    HeartSine samaritan public access defibrillators may not deliver shocks properly

    HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.

    Product
    HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2024·2024-05-22

    HeartSine Public Access Defibrillators Recalled for Voice Prompt Manufacturing Defect

    Certain HeartSine PAD defibrillators may fail to deliver voice prompts during emergency use due to a manufacturing defect, potentially delaying therapy. Visual instructions remain available.

    Product
    HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2024·2024-02-21

    HeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw

    HeartSine samaritan PAD defibrillators shipped in test configuration may have incorrect CPR timing and delayed or no therapy delivery in cardiac events. Users should stop using affected units and contact the manufacturer.

    Product
    HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2143-2023·2023-07-19

    HeartSine Defibrillator Battery and Electrode Cartridges May Fail to Function

    HeartSine battery and electrode cartridges for defibrillators may contain depleted battery cells, rendering them inoperable and preventing cardiac rhythm analysis or therapy delivery. Approximately 30,022 units are affected worldwide.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2023·2023-03-15

    Heartsine Samaritan PAD defibrillators distributed with incorrect language configuration

    Thirteen automated external defibrillators with incorrect language configuration have been recalled by HeartSine Technologies. The wrong language setting could delay or prevent therapy delivery in cardiac emergencies.

    Product
    Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
    Category
    Medical Device
    Distribution
    8 states