HeartSine Technologies Ltd: Device Recall

Recall #Z-2174-2025 · 06/30/2025

Class II: Risk

Recall Details

Recall Number: Z-2174-2025
Classification: Class II
Product Type: Device
Recalling Firm: HeartSine Technologies Ltd
Status: Ongoing
Date Initiated: 06/30/2025
Location: Belfast, United Kingdom
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 190,516 units

Reason for Recall

Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)

Product Description

HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)

Distribution Pattern

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, Austria, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Hong Kong, Indonesia, Ireland, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Singapore, South Korea, Taiwan, Thailand, and United Kingdom.

Other Recalls by HeartSine Technologies Ltd

Class II: Risk 09/18/2025

Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.

View all recalls by HeartSine Technologies Ltd →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.