HeartSine Technologies recalls
8 official recalls and safety alerts involving HeartSine Technologies since 2023-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with HeartSine Technologies or the relevant agency.
- 2026-10-07
USHeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes:…
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
FDA · DeviceHeartSine Technologies LtdU.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO,…Official notice →- 2026-09-16
- US
HeartSine Technologies Ltd recalls HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines)…
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
FDA · DeviceHeartSine Technologies LtdWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2025-10-29
- US
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
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
FDA · DeviceHeartSine Technologies LtdUS Nationwide distribution. Worldwide distribution to Argentina, Australia,…Official notice → - 2025-08-06
- US
HeartSine Technologies Ltd recalls HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
FDA · DeviceHeartSine Technologies LtdWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2024-05-22
- US
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
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 instructional icons will still be…
FDA · DeviceHeartSine Technologies LtdUS Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA,…Official notice → - 2024-02-21
- US
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM…
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 perform CPR for 5-seconds, and…
FDA · DeviceHeartSine Technologies LtdWorldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL,…Official notice → - 2023-07-19
- US
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 Access…
Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.
FDA · DeviceHeartSine Technologies LtdWorldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI,…Official notice → - 2023-03-15
- US
HeartSine Technologies Ltd recalls Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic…
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
FDA · DeviceHeartSine Technologies LtdUS: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New…Official notice →