Medical Device Recall: HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
HeartSine Technologies Ltd · June 30, 2025
Reason for Recall
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, 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.
States Affected
NATIONWIDE
Quantity Affected
190,516 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2174-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.