Class IIIDeviceOngoing

HeartSine Technologies Ltd

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

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.

Details

Recall number: Z-3270-2026
Event ID: 98483
Recall initiated: Jul 27, 2026
Classified: Sep 25, 2026
Reported: Oct 7, 2026
Quantity: 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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Belfast, United Kingdom
Lot / code info: 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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24D98054543E24 24D98054034E24 24D98050678E24 24D98050536E24 24D98055040E24 24D98055328E24 24D98050945E24 24D98055733E24 24D98070147F24 24D98070039F24 24D98070101F24 24D98070105F24 24D98070146F24 24D98070045F24 24D98070067F24 24D98070116F24 24D98070099F24 24D98070044F24 24D98070098F24 24D98070059F24 24D98070073F24 24D98070090F24 24D98070142F24 24D98070124F24 24D98070113F24 24D98070131F24 24D98070112F24 24D98070125F24 24D98070412F24 24D98026634F24 24D98026619F24 24D98048208F24 24D98026934F24 24D98026936F24 24D98048576F24 24D98048559F24 24D98048502F24 24D98048594F24 24D98048571F24 24D98048600F24 24D98048566F24 24D98048609F24 24D98048588F24 24D98048578F24 24D98048554F24 24D98048499F24 24D98048503F24 24D98048504F24 24D98048574F24 24D98048582F24 24D98048491F24 24D98048556F24 24D98048597F24 24D98048598F24 24D98048570F24 24D98048712F24 24D98048560F24 24D98048500F24 24D98048595F24 24D98048575F24 24D98048709F24 24D98048603F24 24D98048495F24 24D98048617F24 24D98048492F24 24D98048497F24 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24D98038146G24 24D98038133G24 24D98074601G24 24D98074572G24 24D98074570G24 24D98074606G24 24D98074541G24 24D98024371H24 24D98024818H24 24D98024808H24 24D98002300H24 24D98002281H24 24D98024650H24 24D98019809H24 24D98019376H24 24D98040257G24 24D98040243G24 24D98040260G24 24D98040262G24 24D98040258G24 24D98040256G24 24D98040263G24 24D98040261G24 24D98001851H24 24D98038364G24 24D98071566G24 24D98071559G24 24D98071562G24 24D98038340G24 24D98038333G24 24D98038334G24 24D98038326G24 24D98071497G24 24D98071498G24 24D98071502G24 24D98019747H24 24D98038331G24 24D98038335G24 24D98038330G24 24D98071567G24 24D98071568G24 24D98038319G24 24D98038318G24 24D98038315G24 24D98038311G24 24D98038304G24 24D98038338G24 24D98038322G24 24D98038306G24 24D98038302G24 24D98038309G24 24D98038303G24 24D98038308G24 24D98071563G24 24D98038352G24 24D98038339G24 24D98038321G24 24D98038314G24 24D98038313G24 24D98038320G24 24D98038323G24 24D98071501G24 24D98038387G24 24D98071499G24 24D98071573G24 24D98071571G24 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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 24E90017941A24 24E90017938A24 24E90017942A24 24E90017939A24 24E90017946A24 24E90017995A24 24E90017990A24 24E90018001A24 24E90017993A24 24E90017978A24 24E90018341A24 24E90017985A24 24E90018327A24 24E90018345A24 24E90018340A24 24E90018342A24 24E90017987A24 24E90017980A24 24E90017986A24 24E90017992A24 24E90017981A24 24E90017977A24 24E90017976A24 24E90018339A24 24E90018326A24 24E90018000A24 24E90018328A24 24E90017314A24 24E90017991A24 24E90017996A24 24E90017994A24 24E90017984A24 24E90017312A24 24E90017322A24 24E90018344A24 24E90018343A24 24E90017989A24 24E90017319A24 24E90017982A24 24E90017998A24 24E90017999A24 24E90017979A24 24E90017273A24 24E90017264A24 24E90017271A24 24E90017263A24 24E90017262A24 24E90017267A24 24E90017274A24 24E90017259A24 24E90017272A24 24E90017266A24 24E90017265A24 24E90017634A24 24E90003313B24 24E90016891A24 24E90017310A24 24E90018357A24 24E90003897B24 24E90003900B24 24E90003929B24 24E90003958B24 24E90003931B24 24E90003936B24 24E90003917B24 24E90003921B24 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