Class 3 Device Recall HeartSine SAM 350P, HeartSine SAM 360P and HeartSine SAM 450P

• Date Initiated by Firm: July 27, 2026
• Date Posted: September 25, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3270-2026
• Recall Event ID: 98483
• PMA Number: P160008
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: 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 code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069
• Code Information: Product - 350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers: 24D98056051D24 24D98057467D24 24D98057468D24 24D98057469D24 24D98068091E24 24D98068097E24 24D98070022F24 24D98070023F24 24D98070024F24 24D98070025F24 24D98070026F24 24D98070027F24 24D98070028F24 24D98070029F24 24D98070030F24 24D98070031F24 24D98070032F24 24D98070033F24 24D98070034F24 24D98070035F24 24D98070036F24 24D98070037F24 24D98070038F24 24D98070040F24 24D98070041F24 24D98070042F24 24D98070043F24 24D98070046F24 24D98070047F24 24D98070048F24 24D98070049F24 24D98070050F24 24D98070051F24 24D98070052F24 24D98070053F24 24D98070054F24 24D98070055F24 24D98070056F24 24D98070057F24 24D98070058F24 24D98070060F24 24D98070061F24 24D98070062F24 24D98070063F24 24D98070064F24 24D98070065F24 24D98070066F24 24D98070068F24 24D98070069F24 24D98070071F24 24D98070072F24 24D98070074F24 24D98070075F24 24D98070076F24 24D98070077F24 24D98070078F24 24D98070079F24 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24D98093156G24 24D98093189G24 24D98039964B24 24D98026855F24 24D98039958B24 24D98052243G24 24D98020465H24 24D98093992H24 24D98026895F24 24D98026879F24 24D98029982A24 24D98048955G24 24D98026897F24 24D98068161E24 24D98053692E24 24D98053766E24 24D98050976E24 Product - 350P US Device, US English (American Airlines) - 2 Min CPR Item code: 350-STR-AA-AV UDI-DI code: 0506016712207 Serial Numbers: 24D98067253D24 24D98067252D24 24D98067251D24 24D98067249D24 24D98056938D24 24D98067250D24 24D98067248D24 24D98067153D24 24D98067160D24 24D98067155D24 24D98067163D24 24D98067180D24 24D98067182D24 24D98067219D24 24D98067186D24 24D98067220D24 24D98067221D24 24D98067215D24 24D98067156D24 24D98067200D24 24D98067195D24 24D98067242D24 24D98067231D24 24D98067234D24 24D98067244D24 24D98067197D24 24D98067232D24 24D98067194D24 24D98067166D24 24D98067165D24 24D98067161D24 24D98067169D24 24D98067241D24 24D98067162D24 24D98067192D24 24D98067159D24 24D98067198D24 24D98067157D24 24D98067203D24 24D98067191D24 24D98067158D24 24D98067246D24 24D98067225D24 24D98067247D24 24D98067206D24 24D98067173D24 24D98067204D24 24D98067213D24 24D98067209D24 24D98067187D24 24D98067207D24 24D98067178D24 24D98067217D24 24D98067214D24 24D98067222D24 24D98067189D24 24D98067212D24 24D98067171D24 24D98067170D24 24D98067177D24 24D98067223D24 24D98067237D24 24D98067172D24 24D98067245D24 24D98067210D24 24D98067211D24 24D98067205D24 24D98067233D24 24D98067208D24 24D98067174D24 24D98067226D24 24D98067190D24 24D98067164D24 24D98067168D24 24D98067167D24 24D98067175D24 24D98067176D24 24D98067181D24 24D98067185D24 24D98067184D24 24D98067216D24 24D98067188D24 24D98067183D24 24D98067218D24 24D98067179D24 24D98067228D24 24D98067229D24 24D98067202D24 24D98067236D24 24D98067235D24 24D98067201D24 24D98067239D24 24D98067230D24 24D98067243D24 24D98067196D24 24D98067193D24 24D98067240D24 24D98067227D24 24D98067224D24 24D98067144D24 24D98067238D24 24D98067121D24 24D98067131D24 Product - 350P US Device, US English with Gateway - 2 Min CPR Item code: 350-STR-US-GW UDI-DI code: 0506016712804 Serial Numbers: 24D98073174E24 24D98033695E24 24D98033694E24 24D98033696E24 24D98033711E24 24D98033688E24 24D98033686E24 Product - 360P US Device, US English - 2 Min CPR Item code: 360-STR-US-10 UDI-DI code: 0506016712068 Serial Numbers: 24E90017943A24 24E90016508A24 24E90017446A24 24E90017448A24 24E90017447A24 24E90016896A24 24E90017445A24 24E90017444A24 24E90017664A24 24E90017257A24 24E90017482A24 24E90017492A24 24E90017662A24 24E90017479A24 24E90017488A24 24E90017661A24 24E90017480A24 24E90017307A24 24E90017659A24 24E90017490A24 24E90017481A24 24E90017486A24 24E90017665A24 24E90017663A24 24E90017258A24 24E90017308A24 24E90017484A24 24E90017489A24 24E90017656A24 24E90017309A24 24E90017224A24 24E90017226A24 24E90016745A24 24E90016512A24 24E90017143A24 24E90017134A24 24E90017136A24 24E90018007A24 24E90017956A24 24E90017954A24 24E90017955A24 24E90017950A24 24E90017940A24 24E90017948A24 24E90017947A24 24E90017937A24 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24E90024762D24 24E90024760D24 24E90018739D24 24E90024759D24 24E90024766D24 24E90023986D24 24E90023990D24 24E90023988D24 24E90023995D24 24E90023987D24 24E90023994D24 24E90019739D24 24E90018744D24 24E90018738D24 24E90003928B24 24E90018353A24 24E90018363A24 24E90017316A24 24E90003310B24 24E90018361A24 24E90003983B24 24E90003492B24 24E90003909B24 24E90017945A24 24E90003893B24 24E90018362A24 24E90017657A24 24E90017483A24 24E90018364A24 24E90018369A24 24E90017311A24 Product - SAM 450P US Device, US English (2 min CPR) Item code: 450-STR-US-10 UDI-DI code: 0506016712069 Serial Numbers: 24G90001624D24 24G90001620D24 24G90001610D24 23G90004172G23 23G90108237L23 23G90108235L23 23G90108212L23 23G90108209L23 23G90108236L23 23G90108213L23 23G90108208L23 23G90108215L23 23G90108210L23 23G90108211L23 23G90108495L23 23G90108226L23 23G90108322L23 23G90108326L23 23G90108222L23 23G90108499L23 23G90108225L23 23G90108497L23 23G90108498L23 23G90108223L23 23G90108492L23 23G90108501L23 23G90108240L23 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• FEI Number: 3004123209
• Recalling Firm/ Manufacturer: HeartSine Technologies Ltd; 207 Airport Road West; Belfast United Kingdom
• For Additional Information Contact: Joyce Staggs; 425-867-5497
• Manufacturer Reason for Recall: Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
• FDA Determined Cause: Process control
• Action: On 07/28/2026, Stryker sent several versions of an Urgent: Medical device recall letter that outlines two issues: 1) An issue with the membrane tail, an internal component, could cause an intermittent fault. 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. 2) A limited number of HeartSine samaritan PAD devices were distributed without the required maintenance insert. This insert contains periodic maintenance instructions implemented as an additional risk control measure. While most devices contain the maintenance insert, this voluntary correction is being initiated to ensure all end users have access to the supplemental maintenance information. For the missing required maintenance insert (issue 2), Customers are instructed to: 1. Identify impacted devices by verifying if your device serial numbers are included in the list at the link https://heartsinerecall.com/HeartSineSamaritanPAD/LookUp. For this field action notice, select AED + Pad-Pak. 2. Download a copy of the missing maintenance insert when acknowledging the recall and store with your devices user manual until a replacement is received. For questions or concerns, contact Stryker Customer Service at +1 8007879537, option 2, from 8 AM to 7 PM Eastern Time, Monday to Friday, your Authorized Distributor, or HeartSine Technologies Technical Support at heartsinesupport@stryker.com.
• Quantity in Commerce: 31,834
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MKJ