← Every firm
HeartSine Technologies Ltd FDA Recalls
7 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (Class IIJul 27, 2026Due to a damaged (over stretched) membrane tail that causes |
| HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04JClass IISep 18, 2025Due to customer complaints, defibrillator pads may contain d |
| HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access DefibrClass IIJun 30, 2025Due to a component manufacturing issue, Automated External D |
| HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450PClass IIApr 8, 2024Automated external defibrillators have a manufacturing issue |
| HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-Class IIFeb 14, 2024Automated external defibrillators were shipped in their test |
| HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan PublicClass IIApr 26, 2023Single use battery and electrode cartridge may be rendered i |
| Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-Class IIFeb 1, 2023Automated external defibrillators were potentially distribut |