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RecallWatchMedical Device Safety
Class IIIOngoingZ-3270-2026

HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator)

HeartSine Technologies LtdBelfast, United KingdomReported Oct 7, 2026 · 6 days ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

Part / Item #
code: 350-STR-US-10
UDI
code: 0506016712067
Serial #
24D98056051D24 24D98057467D24 24D98057468D24 24D98057469D24 24D98068091E24 24D98068097E24 24D98070022F24 24D98070023F24 24D98070024F24 24D98070025F24 24D98070026F24 24D98070027F24 24D98070028F24 24D98…Show all
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 24D98070080F24 24D98070081F24 24D98070082F24 24D98070083F24 24D98070084F24 24D98070085F24 24D98070087F24 24D98070088F24 24D98070089F24 24D98070091F24 24D98070092F24 24D98070093F24 24D98070094F24 24D98070095F24 24D98070096F24 24D98070097F24 24D98070100F24 24D98070102F24 24D98070103F24 24D98070104F24 24D98070107F24 24D98070108F24 24D98070109F24 24D98070110F24 24D98070111F24 24D98070114F24 24D98070115F24 24D98070117F24 24D98070118F24 24D98070119F24 24D98070120F24 24D98070121F24 24D98070122F24 24D98070123F24 24D98070126F24 24D98070127F24 24D98070128F24 24D98070129F24 24D98070130F24 24D98070132F24 24D98070133F24 24D98070134F24 24D98070135F24 24D98070136F24 24D98070138F24 24D98070139F24 24D98070140F24 24D98070141F24 24D98070143F24 24D98070144F24 24D98070145F24 24D98070148F24 24D98070149F24 24D98070150F24 24D98070151F24 24D98070157F24 24D98070160F24 24D98070161F24 24D98070162F24 24D98070163F24 24D98070166F24 24D98056785D24 24D98057279D24 24D98057648D24 24D98053900E24 24D98054669E24 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 24D98048558F24 24D98048605F24 24D98048710F24 24D98048565F24 24D98048586F24 24D98048604F24 24D98048561F24 24D98048606F24 24D98048589F24 24D98048555F24 24D98048564F24 24D98048614F24 24D98048599F24 24D98048590F24 24D98048591F24 24D98048583F24 24D98048601F24 24D98048580F24 24D98048573F24 24D98048618F24 24D98048577F24 24D98048567F24 24D98048501F24 24D98048610F24 24D98048607F24 24D98048711F24 24D98048557F24 24D98048616F24 24D98048585F24 24D98048572F24 24D98048608F24 24D98048592F24 24D98048593F24 24D98048569F24 24D98048619F24 24D98048579F24 24D98048602F24 24D98048498F24 24D98048496F24 24D98048581F24 24D98048587F24 24D98048562F24 24D98048596F24 24D98048611F24 24D98048568F24 24D98048615F24 24D98048584F24 24D98048563F24 24D98026922F24 24D98026921F24 24D98048625F24 24D98026935F24 24D98026838F24 24D98026836F24 24D98026834F24 24D98026928F24 24D98026868F24 24D98026869F24 24D98026933F24 24D98048388F24 24D98028430G24 24D98062685G24 24D98071182G24 24D98071082G24 24D98038091G24 24D98071057G24 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 24D98071581G24 24D98071558G24 24D98071560G24 24D98038295G24 24D98071561G24 24D98071565G24 24D98071564G24 24D98071500G24 24D98071495G24 24D98071496G24 24D98071570G24 24D98038139G24 24D98038307G24 24D98038324G24 24D98038317G24 24D98038316G24 24D98038305G24 24D98038312G24 24D98038293G24 24D98038300G24 24D98038301G24 24D98038297G24 24D98038144G24 24D98038145G24 24D98038337G24 24D98038344G24 24D98038343G24 24D98038345G24 24D98038327G24 24D98038342G24 24D98038296G24 24D98038289G24 24D98038294G24 24D98038290G24 24D98038299G24 24D98064983E24 24D98064976E24 24D98064990E24 24D98050963E24 24D98067351E24 24D98067347E24 24D98067346E24 24D98055977E24 24D98055973E24 24D98055974E24 24D98050964E24 24D98067337E24 24D98055964E24 24D98055976E24 24D98060043E24 24D98055967E24 24D98055972E24 24D98055969E24 24D98055978E24 24D98055966E24 24D98055981E24 24D98055968E24 24D98055971E24 24D98055979E24 24D98055982E24 24D98055970E24 24D98050987E24 24D98050978E24 24D98055940E24 24D98050966E24 24D98050967E24 24D98050956E24 24D98050981E24 24D98067336E24 24D98067335E24 24D98050982E24 24D98050977E24 24D98050988E24 24D98064993E24 24D98055950E24 24D98055949E24 24D98055951E24 24D98055942E24 24D98055943E24 …
Part / Item #
code: 350-STR-AA-AV
UDI
code: 0506016712207
Serial #
24D98067253D24 24D98067252D24 24D98067251D24 24D98067249D24 24D98056938D24 24D98067250D24 24D98067248D24 24D98067153D24 24D98067160D24 24D98067155D24 24D98067163D24 24D98067180D24 24D98067182D24 24D98…Show all
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
Part / Item #
code: 350-STR-US-GW
UDI
code: 0506016712804
Serial #
24D98073174E24 24D98033695E24 24D98033694E24 24D98033696E24 24D98033711E24 24D98033688E24 24D98033686E24 Product - 360P US Device, US English - 2 Min CPR
Part / Item #
code: 360-STR-US-10
Show 2 more code fields
UDI
code: 0506016712068
Serial #
24E90017943A24 24E90016508A24 24E90017446A24 24E90017448A24 24E90017447A24 24E90016896A24 24E90017445A24 24E90017444A24 24E90017664A24 24E90017257A24 24E90017482A24 24E90017492A24 24E90017662A24 24E90…Show all
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 24E90003068B24 24E90003067B24 24E90003493B24 24E90003494B24 24E90003306B24 24E90003312B24 24E90003309B24 24E90013330B24 24E90004172B24 24E90005978B24 24E90018657B24 24E90001548B24 24E90014938B24 24E90015411B24 24E90002912B24 24E90001072B24 24E90015420B24 24E90001638B24 24E90000739B24 24E90000958B24 24E90006176B24 24E90006182B24 24E90006179B24 24E90006181B24 24E90004468B24 24E90004449B24 24E90004476B24 24E90004622B24 24E90004471B24 24E90004457B24 24E90004398B24 24E90004629B24 24E90004389B24 24E90004455B24 24E90004450B24 24E90004386B24 24E90004470B24 24E90004474B24 24E90004391B24 24E90004396B24 24E90004448B24 24E90004390B24 24E90004388B24 24E90004621B24 24E90004453B24 24E90004451B24 24E90004397B24 24E90004392B24 24E90004478B24 24E90004473B24 24E90004393B24 24E90004623B24 24E90004452B24 24E90004624B24 24E90004387B24 24E90004477B24 24E90004456B24 24E90004626B24 24E90004472B24 24E90004454B24 24E90004625B24 24E90004469B24 24E90005977B24 24E90004724B24 24E90004755B24 24E90004752B24 24E90004730B24 24E90004749B24 24E90004726B24 24E90004721B24 24E90004750B24 24E90004751B24 24E90004728B24 24E90004722B24 24E90004723B24 24E90004727B24 24E90006184B24 24E90014632B24 24E90002115B24 24E90004710B24 24E90004695B24 24E90004707B24 24E90004716B24 24E90004642B24 24E90004711B24 24E90004640B24 24E90004700B24 24E90004717B24 24E90004733B24 24E90004704B24 24E90004697B24 24E90004699B24 24E90004731B24 24E90004641B24 24E90004698B24 24E90004634B24 24E90004693B24 24E90004696B24 24E90004719B24 24E90004706B24 24E90004631B24 24E90004638B24 24E90004705B24 24E90004636B24 24E90004635B24 24E90004637B24 24E90004735B24 24E90004702B24 24E90004734B24 24E90004639B24 24E90004715B24 24E90004718B24 24E90004694B24 24E90004633B24 24E90004732B24 24E90004701B24 24E90004708B24 24E90004632B24 24E90002370B24 24E90004612B24 24E90004613B24 24E90004616B24 24E90004618B24 24E90004615B24 24E90004617B24 24E90004619B24 24E90006185B24 24E90006177B24 24E90006183B24 24E90006180B24 24E90006178B24 24E90004464B24 24E90004466B24 24E90004462B24 24E90004458B24 24E90005791B24 24E90004399B24 24E90004609B24 24E90003808B24 24E90004607B24 24E90004467B24 24E90004400B24 24E90004461B24 24E90004460B24 24E90003835B24 24E90005794B24 24E90004459B24 24E90004531B24 24E90005784B24 24E90005792B24 24E90003807B24 24E90004605B24 24E90004530B24 24E90004599B24 24E90004532B24 24E90005783B24 24E90004463B24 24E90004602B24 24E90004598B24 24E90003809B24 24E90005788B24 24E90005793B24 24E90004600B24 24E90004601B24 24E90004594B24 24E90004593B24 24E90005790B24 24E90003818B24 24E90005781B24 24E90005785B24 24E90004465B24 24E90004610B24 24E90006156B24 24E90005890B24 24E90005906B24 24E90005897B24 24E90006153B24 24E90005892B24 24E90005896B24 24E90005898B24 24E90005902B24 24E90005913B24 24E90006154B24 24E90005894B24 24E90006155B24 24E90005899B24 24E90005910B24 24E90005915B24 24E90005901B24 24E90005893B24 24E90005900B24 24E90005891B24 24E90005904B24 24E90005905B24 24E90005895B24 24E90005903B24 24E90005907B24 24E90005795B24 24E90005797B24 24E90006150B24 24E90005883B24 24E90005880B24 24E90006145B24 24E90006151B24 24E90005881B24 24E90006143B24 24E90005889B24 24E90006198B24 24E90006197B24 24E90006193B24 24E90006200B24 24E90006148B24 24E90006152B24 24E90005885B24 24E90006149B24 24E90006188B24 24E90005886B24 24E90005888B24 24E90005882B24 24E90005884B24 24E90006146B24 24E90006190B24 24E90006144B24 24E90014657B24 24E90006158B24 24E90006168B24 24E90006157B24 24E90006173B24 24E90006174B24 24E90006160B24 24E90006159B24 24E90006175B24 24E90006169B24 24E90006165B24 24E90006186B24 24E90006172B24 24E90006162B24 24E90006161B24 24E90006164B24 24E90006192B24 24E90006167B24 24E90006163B24 24E90015664B24 23E90139374B24 24E90012588A24 24E90005976B24 24E90017923B24 24E90015530B24 24E90001785B24 24E90015665B24 24E90004170B24 24E90001501B24 24E90001288B24 24E90005937B24 24E90005925B24 24E90015201A24 24E90017790A24 24E90017788A24 24E90017789A24 24E90017787A24 24E90017795A24 24E90018540A24 24E90017791A24 24E90018538A24 24E90018542A24 24E90017793A24 24E90018536A24 24E90018543A24 24E90017867A24 24E90018535A24 24E90017798A24 24E90017792A24 24E90017794A24 24E90018541A24 24E90018534A24 24E90018533A24 24E90018530A24 24E90015382A24 24E90018529A24 24E90017888A24 24E90015383A24 24E90017785A24 24E90017889A24 24E90000689A24 24E90017892A24 24E90017782A24 24E90018532A24 24E90018527A24 …
Additional code information

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23G90108223L23 23G90108492L23 23G90108501L23 23G90108240L23 23G90108227L23 23G90108242L23 23G90108239L23 23G9010 …

What the firm is doing

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.

DistributionShow details

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.

Class IIIWhat this means

Use of the product is not likely to cause adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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