Recalls · Brand
HeartSine Technologies Ltd recalls
Every recall we track for HeartSine Technologies Ltd — 8 in all, from 2023–2026 — plus the complaints and injury reports the public filed about them.
8recalls
Recalls per year, by danger level
8 recalls since 2017.
All FDA recall records for HeartSine Technologies Ltd since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 1 | 1 | 0 | 2 |
| 2024 | 0 | 2 | 0 | 0 | 2 |
| 2025 | 0 | 1 | 1 | 0 | 2 |
| 2026 (to date) | 0 | 0 | 2 | 0 | 2 |
What to do if you have a recalled HeartSine Technologies Ltd product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All HeartSine Technologies Ltd recalls
8 shown- Lower riskMedical device
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI
HeartSine iECG is a portable, wearable ECG monitor that provides continuous heart rhythm monitoring for patients with cardiac conditions.
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24E90015275A24 24E90015277A24 24E90001278A24 24E90001281A24 24E90001283A24 24E90001284A24 24E90001256A24 24E90000644A24 24E90000645A24 24E90015280A24 24E90001280A24 24E90000648A24 24E90000646A24 24E90001253A24 24E90000639A24 24E90000640A24 24E90000636A24 24E90000635A24 24E90001287A24 24E90000642A24 24E90001285A24 24E90000643A24 24E90001286A24Jul 27, 2026 - Lower riskMedical device
HeartSine Technologies Ltd recalls HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English
HeartSine 350P US Device, US English (American Airlines) - 2 Min CPR
HeartSineJul 27, 2026 - Use cautionMedical device
HeartSine Technologies Ltd recalls 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
HeartSine recalls Pad-Pak defibrillator pads with damaged pins that could disrupt mechanical fit and electrical contact. Check model numbers and lots for affected units.
HeartSineSep 18, 2025 - Lower riskMedical device
HeartSine Technologies Ltd recalls HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access
HeartSine 350P, 360P, 450P Defibrillators - HeartSine's latest defibrillators with advanced technology for effective cardiac care.
HeartSineJun 30, 2025 - Use cautionMedical device
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
HeartSine recalls SAM 350P, 360P, and 450P public defibrillators that may fail to deliver voice prompts during emergencies, potentially delaying critical therapy.
HeartSineApr 8, 2024 - Use cautionMedical device
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10,
HeartSine recalls specific Samaritan PAD defibrillators with potential for incorrect CPR prompts and shock intervals, risking delayed life-saving therapy. Affected units have unique model numbers and were sold in the US, UK, and Japan.
HeartSineFeb 14, 2024 - Lower riskMedical device
HeartSine Technologies Ltd recalls HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public
HeartSine recalls specific defibrillator pads that may fail to analyze or deliver therapy due to depleted battery cells. Affected models include HeartSine Samaritan Public Access Defibrillators with certain serial numbers.
HeartSineApr 26, 2023 - Use cautionMedical device
HeartSine Technologies Ltd recalls Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P
HeartSine recalls SAM 350P, 360P, and 500P defibrillators that may have incorrect language settings, risking delayed or no life-saving shocks during cardiac emergencies.
HeartSineFeb 1, 2023
HeartSine Technologies Ltd recall questions
How many recalls has HeartSine Technologies Ltd had?
8 recalls from HeartSine Technologies Ltd are on record with U.S. safety agencies, from 2023–2026.
What is the most recent HeartSine Technologies Ltd recall?
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI, dated Jul 27, 2026. Every HeartSine Technologies Ltd recall is listed on this page, newest first.
What should I do if I have a recalled HeartSine Technologies Ltd product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new HeartSine Technologies Ltd recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.