HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD (Public Access Defibrillator)
FDA Recall Z-2174-2025 · Posted 2025-07-25
Recalling FirmHeartSine Technologies Ltd
Recall StatusOpen, Classified
Product CodeMKJ
Date Initiated2025-06-30
Product Quantity190,516 units
Reason for Recall
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Firm Action
On 06/30/2025, the firm sent via USPS First Class an "URGENT: MEDICAL device recall" Letter to customers informing them Stryker has determined that for the HeartSine samaritan PAD, a manufacturing process issue related to a circuit board component may impair the device's ability to function or cause failure. This failure could occur at any point when the device is holding a charge in preparation to deliver therapy, while delivering a shock, or after shock delivery. The device becomes inoperable after the failure occurs.
Customer are instructed to:
1. Identify impacted devices by verifying if their device serial numbers are included in the list at the link https://www.stryker.com/us/en/emergency-care/product-notice/heartsine/index.html
2. Submit customer response electronically via the QR code scan or link https://bit.ly/fa318-heartsine, or response via email to: [email protected] and include the following
Subject: FA 318 HeartSine T3 - Response from <<>>
Email Body:
-Customer ID, Customer Name, title and email address
-The number of devices impacted by model, and serial numbers
-Provide if any devices have been further distributed
3. Until a replacement is available, Stryker recommends keeping HeartSine device in service if there is no alternative public access defibrillator.
For questions or concerns, contact Stryker Customer at +1 800-787-9537, option 2 from 8:00 AM to 7:00 PM (Eastern Time) Monday thru Friday or contact Technical Support at [email protected]
Root Cause
Process change control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.