Belfast, United Kingdom
HeartSine Technologies Ltd recalls
8 recalls recorded since 2018, most recently on 27 July 2026. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)8
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 July 2026
- Reason
- Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SD,TN, TX, UT, VA, WA, WI, WV and WY. The countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Hong Ko
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3120-2026
- HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gatew
Ongoing Class III Medical devices
- Recall started
- 27 July 2026
- Reason
- Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
- Distribution
- U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3270-2026
- HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI co
Ongoing Class II Medical devices
- Recall started
- 18 September 2025
- Reason
- Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
- Distribution
- US Nationwide distribution. Worldwide distribution to Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Ita
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0288-2026
- 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
Ongoing Class II Medical devices
- Recall started
- 30 June 2025
- Reason
- Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2174-2025
- HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Ongoing Class II Medical devices
- Recall started
- 8 April 2024
- Reason
- 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 present, but this issue could potentially lead to no therapy or a delay in therapy.
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1820-2024
- HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Ongoing Class II Medical devices
- Recall started
- 14 February 2024
- Reason
- 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 it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.
- Distribution
- Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1141-2024
- 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-BA
Ongoing Class II Medical devices
- Recall started
- 26 April 2023
- Reason
- 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.
- Distribution
- Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA & WI and OUS (countries of): Australia, Canada, Denmark, France, Iceland, Ireland, Israel, Italy, Japan, Korea,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2143-2023
- 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
Ongoing Class II Medical devices
- Recall started
- 1 February 2023
- Reason
- Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
- Distribution
- US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1217-2023
- Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.