Recall archive / FDA device enforcement

HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrilla... — FDA record Z-2174-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 30, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Reason: Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Classification: Class II
Recalling firm: HeartSine Technologies Ltd
Quantity: 190,516 units
Agency-reported status: Ongoing
Source record identifier: Z-2174-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	U.S. Model 350P Item Number: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers 23D98002591E23 23D98002593E23 23D98002594E23 23D98002595E23 23D98002597E23 23D98002608E23 23D98002638E23 23D98002668E23 23D98002669E23 23D98002699E23 23D98002734E23 23D98002751E23 23D98002755E23 23D98002756E23 23D98002758E23 23D98002760E23 23D98002761E23 23D98002765E23 23D98002772E23 23D98002773E23 23D98002774E23 23D98002845E23 23D98002852E23 23D98002853E23 23D98002855E23 23D98002856E23 23D98002857E23 23D98002858E23 23D98002859E23 23D98002877E23 23D98002879E23 23D98002885E23 23D98002887E23 23D98002987E23 23D98002989E23 23D98002990E23 23D98003083E23 23D98003092E23 23D98003117I23 23D98003118E23 23D98003459D23 23D98003475D23 23D98008368E23 23D98008390E23 23D98008877E23 23D98011224D23 23D98012987E23 23D98012991E23 23D98012993E23 23D98012994E23 23D98012998E23 23D98012999E23 23D98013490F23 23D98013500F23 23D98016785E23 23D98017244E23 23D98020031C23 23D98020033C23 23D98020036C23 23D98020351C23 23D98020356C23 23D98020386C23 23D98020403C23 23D98020405C23 23D98020406C23 23D98020408C23 23D98020420C23 23D98020592D23 23D98020594D23 23D98020622D23 23D98020623D23 23D98020627D23 23D98020628D23 23D98020629D23 23D98020631D23 23D98020639D23 23D98020640D23 23D98020732D23 23D98023168E23 23D98100628I23 23D98100631I23 23D98100634I23 23D98100648I23 23D98102318K23 23D98104318J23 23D98104432J23 23D98104622J23 23D98104623J23 23D98104624J23 23D98104628J23 23D98104700J23 23D98104737J23 23D98104741J23 23D98104835J23 23D98104867J23 23D98104868J23 23D98104874J23 23D98104889J23 23D98104946J23 23D98104980J23 23D98104985J23 23D98104986J23 23D98104988J23 23D98105086J23 23D98105145J23 23D98105146J23 23D98105147J23 23D98105148J23 23D98105149J23 23D98105150J23 23D98105151J23 23D98105152J23 23D98105153K23 23D98105917J23 23D98105968J23 23D98105980J23 23D98106055J23 23D98108733I23 23D98109510I23 23D98109528I23 23D98109530I23 23D98109536I23 23D98109537I23 23D98109539I23 23D98109540I23 23D98109542I23 23D98109549I23 23D98109556I23 23D98109588I23 23D98109652I23 23D98109657I23 23D98109665I23 23D98109666I23 23D98109667I23 23D98109705I23 23D98109763I23 23D98109801I23 23D98109885I23 23D98109923I23 23D98110114I23 23D98110136I23 23D98110249I23 23D98110250I23 23D98110251I23 23D98110257I23 23D98110258I23 23D98110266I23 23D98110267I23 23D98110276I23 23D98110554H23 23D98110555H23 23D98110640H23 23D98110708H23 23D98111442K23 23D98111445K23 23D98111447K23 23D98111448K23 23D98111449K23 23D98111450K23 23D98111458K23 23D98111461K23 23D98111469K23 23D98111470K23 23D98111472K23 23D98111474K23 23D98111476K23 23D98111477K23 23D98111478K23 23D98111479K23 23D98111486K23 23D98111489K23 23D98111493K23 23D98111874I23 23D98111877I23 23D98111878I23 23D98111879I23 23D98111880I23 23D98111958I23 23D98111959I23 23D98111960I23 23D98112643G23 23D98112645G23 23D98112682G23 23D98113854H23 23D98113855H23 23D98115103H23 23D98115106H23 23D98115108H23 23D98115109H23 23D98115297H23 23D98115381H23 23D98115387H23 23D98115389H23 23D98115394H23 23D98115485H23 23D98116132G23 23D98117662G23 23D98117923I23 23D98118679G23 23D98120510I23 23D98120950I23 23D98121262J23 23D98121548J23 23D98121553J23 23D98121554J23 23D98121799J23 23D98121800J23 23D98121801J23 23D98123064I23 23D98123065I23 23D98123066I23 23D98123067I23 23D98123070I23 23D98123080I23 23D98123081I23 23D98123088I23 23D98123089I23 23D98123174I23 23D98123179I23 23D98123186I23 23D98123199I23 23D98123379I23 23D98123419I23 23D98124392J23 23D98124394J23 23D98124397J23 23D98124400J23 23D98124536J23 23D98124537J23 23D98124911J23 23D98125324H23 23D98125325H23 23D98125404H23 23D98125464I23 23D98125830G23 23D98125839G23 23D98126365G23 23D98126366G23 23D98126367G23 23D98126398G23 23D98126399G23 23D98126400G23 23D98126401G23 23D98126402G23 23D98126403G23 23D98126404G23 23D98126831J23 23D98127775H23 23D98127823H23 23D98127824H23 23D98127826H23 23D98127930H23 23D98128037H23 23D98128158K23 23D98128539H23 23D98128540H23 23D98128542H23 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23D98135107H23 23D98135111H23 23D98135112H23 23D98135137H23 23D98135138H23 23D98135142H23 23D98135143H23 23D98135144H23 23D98135145H23 23D98135289H23 23D98135303H23 23D98135358H23 23D98135360H23 23D98135361H23 23D98135362H23 23D98135363H23 23D98135365H23 23D98135367H23 23D98135425H23 23D98135497H23 23D98136642H23 23D98136651H23 23D98137175K23 23D98139118I23 23D98139119I23 23D98139120I23 23D98139121I23 23D98139123I23 23D98139125I23 23D98139126I23 23D98139127I23 23D98139339J23 23D98139603J23 23D98139677I23 23D98139678I23 23D98139679I23 23D98139686I23 23D98139687I23 23D98139761I23 23D98139762I23 23D98139769I23 23D98139770I23 23D98139866I23 23D98139867I23 23D98139868I23 23D98146144K23 23D98146170K23 23D98146430K23 23D98146463K23 23D98146490K23 23D98146492K23 23D98146494K23 23D98146495K23 23D98146512K23 23D98146742K23 23D98146749K23 23D98146837K23 23D98147036K23 23D98147037K23 23D98147038K23 23D98147039K23 23D98147040K23 23D98147042K23 23D98147043K23 23D98148042J23 23D98148048J23 23D98148406J23 23D98148432J23 23D98148436J23 23D98149738K23 23D98149754K23 23D98149756K23 23D98149760K23 23D98149761K23 23D98149812K23 23D98149813K23 23D98149818K23 23D98149841K23 23D98149856K23 23D98149859K23 24D98029601A24 24D98034886B24 24D98036930A24 24D98037136A24 24D98037137A24 24D98037139A24 24D98037140A24 24D98037188A24 24D98037283A24 24D98037289A24 24D98037294A24 24D98037300A24 24D98037398A24 24D98037415A24 24D98037567A24 24D98037754A24 24D98037757A24 24D98037759A24 24D98037764A24 24D98037766A24 24D98042105A24 24D98042106A24 24D98042108A24 24D98043355A24 24D98046232A24 24D98046233A24 24D98046235A24 24D98046491A24 24D98046493A24 24D98046494A24 24D98046495A24 24D98046496A24 24D98046497A24 24D98046498A24 24D98046499A24 24D98072439A24 24D98072607A24 24D98072696A24 24D98072904A24 24D98072915A24 24D98072933A24 24D98072935A24 Model 360P Item Number: 360-STR-US-10 UDI-DI Code: 0506016712068 Serial Numbers: 23E90148013K23 24E90003928B24 23E90131693I23 23E90148113K23 24E90020489B24 23E90148518K23 23E90141749K23 24E90018353A24 23E90131752I23 23E90147550K23 23E90147549K23 24E90018363A24 23E90110241H23 23E90131753I23 24E90017316A24 24E90003310B24 23E90135479J23 23E90017678D23 23E90131667I23 23E90103892H23 23E90103894H23 23E90011797D23 23E90107066G23 23E90131427H23 23E90131432H23 23E90006904D23 23E90102226G23 23E90102229G23 23E90131440H23 23E90102659G23 23E90116352H23 23E90148114K23 23E90102210G23 23E90131434H23 23E90148044K23 24E90018361A24 23E90131437H23 23E90137583I23 24E90003983B24 23E90131899I23 23E90006905D23 24E90003492B24 24E90003909B24 23E90102783G23 23E90148066K23 23E90011958D23 23E90145717K23 23E90145714K23 23E90017670D23 23E90131447H23 23E90148035K23 23E90131419H23 23E90017679D23 23E90103889H23 24E90017945A24 23E90147258K23 23E90131413H23 23E90131414H23 23E90103890H23 23E90131900I23 23E90110279H23 23E90131420H23 23E90131896I23 23E90131898I23 23E90131895I23 23E90110826H23 23E90110828H23 23E90110832H23 23E90131438H23 23E90131389H23 23E90107138G23 24E90003893B24 24E90018362A24 24E90017657A24 24E90017483A24 24E90018364A24 23E90110244H23 23E90131748I23 23E90131768I23 23E90011792D23 23E90131904I23 23E90148045K23 23E90107042G23 23E90131448H23 23E90139250I23 24E90018369A24 23E90105485F23 23E90102232G23 23E90107065G23 23E90107068G23 23E90145869K23 23E90145523K23 23E90145475K23 23E90145500K23 23E90102169G23 23E90110286H23 23E90131750I23 23E90131435H23 23E90131431H23 23E90145612K23 23E90147674K23 23E90145484K23 23E90102339G23 23E90130517J23 23E90144000K23 23E90147651K23 23E90145853K23 23E90145852K23 23E90145850K23 24E90017311A24 23E90148014K23 23E90145540K23 23E90006926D23 23E90004982D23 23E90006886D23 23E90006971D23 23E90004978D23 23E90004984D23 23E90006885D23 23E90006964D23 23E90004981D23 23E90006961D23 23E90004983D23 23E90006890D23 23E90006866D23 23E90006910D23 23E90006880D23 23E90004979D23 23E90006970D23 23E90006962D23 23E90006863D23 23E90006968D23 23E90006879D23 23E90006878D23 23E90006884D23 23E90006892D23 23E90006864D23 23E90006903D23 23E90006891D23 23E90006889D23 23E90006893D23 23E90006972D23 23E90006973D23 23E90006907D23 23E90006868D23 23E90006966D23 23E90006930D23 23E90006969D23 23E90006814D23 23E90006815D23 23E90006817D23 23E90006816D23 23E90006813D23 23E90017627D23 23E90017634D23 23E90017628D23 23E90017632D23 23E90017624D23 23E90017636D23 23E90017631D23 23E90017394D23 23E90017735D23 23E90017677D23 23E90017734D23 23E90017392D23 23E90017637D23 23E90017676D23 23E90017674D23 23E90017672D23 23E90017731D23 23E90017675D23 23E90017393D23 23E90017396D23 23E90017395D23 23E90017381D23 23E90017384D23 23E90017382D23 23E90017383D23 Model 450P Item Number: 450-STR-US-10 UDI-DI code: 0506016712069 Serial Numbers: 23G90001569G23 24G90012089B24 24G90012094B24 24G90012120B24 24G90012118B24 23G90006184D23 23G90009052H23 23G90106476K23 23G90006183D23 23G90106676K23 23G90103796J23 23G90003902H23 23G90105515K23 23G90106520K23 23G90106492K23 24G90011087B24 24G90011095B24 23G90107201J23 23G90112607I23 23G90006018D23 23G90105531K23 23G90105573K23 24G90011227B24 23G90110119I23 23G90106011K23 23G90100686K23 23G90106451K23 23G90102992K23 23G90106454K23 23G90106450K23 23G90110201I23 23G90110231I23 23G90100180K23 23G90009404H23 23G90009087H23 23G90009081H23 23G90105399K23 24G90015878A24 23G90008758G23 23G90007502E23 23G90107962K23 23G90102997K23 24G90015874A24 23G90107191J23 23G90107190J23 23G90107195J23 23G90102586J23 23G90107957K23 23G90107393J23 23G90106336K23 23G90008501G23 23G90105667K23 23G90102993K23 23G90106219K23 23G90107945K23 23G90107939K23 23G90112605I23 23G90112599I23 23G90110351I23 23G90110352I23 23G90110348I23 23G90110410I23 23G90112592I23 23G90110127I23 23G90102297K23 24G90016931B24 23G90100548K23 23G90106720K23 24G90015868A24 23G90106449K23 23G90106442K23 23G90106593K23 23G90106591K23 23G90100684K23 23G90106258K23 23G90106261K23 23G90000087H23 23G90000388H23 23G90106033K23 23G90105574K23 23G90110355I23 23G90008634G23 23G90009577H23 23G90109116J23 24G90008247D24 23G90106617K23 23G90106612K23 23G90106619K23 23G90106616K23 23G90106610K23 23G90106601K23 23G90100661K23 23G90100550K23 23G90106684K23 23G90106689K23 23G90101190L23 23G90106645K23 23G90109102J23 23G90106238K23 23G90109029J23 23G90109096J23 23G90105721K23 23G90000296H23 23G90102987K23 23G90003942H23 23G90101215L23 23G90107607J23 23G90107606J23 24G90011267B24 23G90006044D23 23G90112597I23 23G90009414H23 23G90107387J23 23G90107392J23 23G90109373L23 23G90109464L23 23G90107605J23 23G90106830K23 23G90103685L23 23G90101191L23 23G90109047J23 23G90001557G23 23G90001499I23 23G90008538G23 23G90006616G23 24G90001625D24 23G90008434G23 23G90008503G23 23G90008498G23 23G90008435G23 23G90008499G23 23G90008500G23 23G90008436G23 23G90008438G23 23G90008504G23 23G90000094H23 23G90001498I23 23G90112676I23 23G90110125I23 23G90110124I23 23G90112596I23 23G90001698L23 23G90008129L23 24G90011961B24 24G90011770B24 24G90016892B24 24G90001627D24 23G90112598I23 24G90011079B24 24G90011084B24 23G90106377K23 23G90105518K23 23G90105514K23 23G90103206J23 23G90107343J23 23G90107340J23 23G90110088I23 23G90106170K23 23G90108000K23 23G90106543K23 23G90...

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Details supplied by the agency

Lot, code or applicability

U.S. Model 350P Item Number: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers 23D98002591E23 23D98002593E23 23D98002594E23 23D98002595E23 23D98002597E23 23D98002608E23 23D98002638E23 23D98002668E23 23D98002669E23 23D98002699E23 23D98002734E23 23D98002751E23 23D98002755E23 23D98002756E23 23D98002758E23 23D98002760E23 23D98002761E23 23D98002765E23 23D98002772E23 23D98002773E23 23D98002774E23 23D98002845E23 23D98002852E23 23D98002853E23 23D98002855E23 23D98002856E23 23D98002857E23 23D98002858E23 23D98002859E23 23D98002877E23 23D98002879E23 23D98002885E23 23D98002887E23 23D98002987E23 23D98002989E23 23D98002990E23 23D98003083E23 23D98003092E23 23D98003117I23 23D98003118E23 23D98003459D23 23D98003475D23 23D98008368E23 23D98008390E23 23D98008877E23 23D98011224D23 23D98012987E23 23D98012991E23 23D98012993E23 23D98012994E23 23D98012998E23 23D98012999E23 23D98013490F23 23D98013500F23 23D98016785E23 23D98017244E23 23D98020031C23 23D98020033C23 23D98020036C23 23D98020351C23 23D98020356C23 23D98020386C23 23D98020403C23 23D98020405C23 23D98020406C23 23D98020408C23 23D98020420C23 23D98020592D23 23D98020594D23 23D98020622D23 23D98020623D23 23D98020627D23 23D98020628D23 23D98020629D23 23D98020631D23 23D98020639D23 23D98020640D23 23D98020732D23 23D98023168E23 23D98100628I23 23D98100631I23 23D98100634I23 23D98100648I23 23D98102318K23 23D98104318J23 23D98104432J23 23D98104622J23 23D98104623J23 23D98104624J23 23D98104628J23 23D98104700J23 23D98104737J23 23D98104741J23 23D98104835J23 23D98104867J23 23D98104868J23 23D98104874J23 23D98104889J23 23D98104946J23 23D98104980J23 23D98104985J23 23D98104986J23 23D98104988J23 23D98105086J23 23D98105145J23 23D98105146J23 23D98105147J23 23D98105148J23 23D98105149J23 23D98105150J23 23D98105151J23 23D98105152J23 23D98105153K23 23D98105917J23 23D98105968J23 23D98105980J23 23D98106055J23 23D98108733I23 23D98109510I23 23D98109528I23 23D98109530I23 23D98109536I23 23D98109537I23 23D98109539I23 23D98109540I23 23D98109542I23 23D98109549I23 23D98109556I23 23D98109588I23 23D98109652I23 23D98109657I23 23D98109665I23 23D98109666I23 23D98109667I23 23D98109705I23 23D98109763I23 23D98109801I23 23D98109885I23 23D98109923I23 23D98110114I23 23D98110136I23 23D98110249I23 23D98110250I23 23D98110251I23 23D98110257I23 23D98110258I23 23D98110266I23 23D98110267I23 23D98110276I23 23D98110554H23 23D98110555H23 23D98110640H23 23D98110708H23 23D98111442K23 23D98111445K23 23D98111447K23 23D98111448K23 23D98111449K23 23D98111450K23 23D98111458K23 23D98111461K23 23D98111469K23 23D98111470K23 23D98111472K23 23D98111474K23 23D98111476K23 23D98111477K23 23D98111478K23 23D98111479K23 23D98111486K23 23D98111489K23 23D98111493K23 23D98111874I23 23D98111877I23 23D98111878I23 23D98111879I23 23D98111880I23 23D98111958I23 23D98111959I23 23D98111960I23 23D98112643G23 23D98112645G23 23D98112682G23 23D98113854H23 23D98113855H23 23D98115103H23 23D98115106H23 23D98115108H23 23D98115109H23 23D98115297H23 23D98115381H23 23D98115387H23 23D98115389H23 23D98115394H23 23D98115485H23 23D98116132G23 23D98117662G23 23D98117923I23 23D98118679G23 23D98120510I23 23D98120950I23 23D98121262J23 23D98121548J23 23D98121553J23 23D98121554J23 23D98121799J23 23D98121800J23 23D98121801J23 23D98123064I23 23D98123065I23 23D98123066I23 23D98123067I23 23D98123070I23 23D98123080I23 23D98123081I23 23D98123088I23 23D98123089I23 23D98123174I23 23D98123179I23 23D98123186I23 23D98123199I23 23D98123379I23 23D98123419I23 23D98124392J23 23D98124394J23 23D98124397J23 23D98124400J23 23D98124536J23 23D98124537J23 23D98124911J23 23D98125324H23 23D98125325H23 23D98125404H23 23D98125464I23 23D98125830G23 23D98125839G23 23D98126365G23 23D98126366G23 23D98126367G23 23D98126398G23 23D98126399G23 23D98126400G23 23D98126401G23 23D98126402G23 23D98126403G23 23D98126404G23 23D98126831J23 23D98127775H23 23D98127823H23 23D98127824H23 23D98127826H23 23D98127930H23 23D98128037H23 23D98128158K23 23D98128539H23 23D98128540H23 23D98128542H23 23D98128543H23 23D98128544H23 23D98128547H23 23D98128548H23 23D98128645H23 23D98128649H23 23D98128650H23 23D98128704H23 23D98128720H23 23D98128893H23 23D98128894H23 23D98128900H23 23D98128901H23 23D98128903H23 23D98128904H23 23D98128905H23 23D98128906H23 23D98128908H23 23D98128909H23 23D98128910H23 23D98128912H23 23D98128913H23 23D98128968H23 23D98128970H23 23D98128977H23 23D98129000H23 23D98129002H23 23D98129003H23 23D98129004H23 23D98129005H23 23D98129006H23 23D98129013H23 23D98129239H23 23D98129242H23 23D98129243H23 23D98129244H23 23D98129245H23 23D98129364H23 23D98129365H23 23D98129518H23 23D98129538H23 23D98129539H23 23D98129540H23 23D98129549H23 23D98129559H23 23D98129755H23 23D98129756H23 23D98129761H23 23D98129863H23 23D98129961H23 23D98129963H23 23D98129966H23 23D98130039H23 23D98130080H23 23D98130143H23 23D98130856H23 23D98130857H23 23D98130859H23 23D98130860H23 23D98133360H23 23D98133362H23 23D98133363H23 23D98134931H23 23D98134938H23 23D98135038H23 23D98135048H23 23D98135107H23 23D98135111H23 23D98135112H23 23D98135137H23 23D98135138H23 23D98135142H23 23D98135143H23 23D98135144H23 23D98135145H23 23D98135289H23 23D98135303H23 23D98135358H23 23D98135360H23 23D98135361H23 23D98135362H23 23D98135363H23 23D98135365H23 23D98135367H23 23D98135425H23 23D98135497H23 23D98136642H23 23D98136651H23 23D98137175K23 23D98139118I23 23D98139119I23 23D98139120I23 23D98139121I23 23D98139123I23 23D98139125I23 23D98139126I23 23D98139127I23 23D98139339J23 23D98139603J23 23D98139677I23 23D98139678I23 23D98139679I23 23D98139686I23 23D98139687I23 23D98139761I23 23D98139762I23 23D98139769I23 23D98139770I23 23D98139866I23 23D98139867I23 23D98139868I23 23D98146144K23 23D98146170K23 23D98146430K23 23D98146463K23 23D98146490K23 23D98146492K23 23D98146494K23 23D98146495K23 23D98146512K23 23D98146742K23 23D98146749K23 23D98146837K23 23D98147036K23 23D98147037K23 23D98147038K23 23D98147039K23 23D98147040K23 23D98147042K23 23D98147043K23 23D98148042J23 23D98148048J23 23D98148406J23 23D98148432J23 23D98148436J23 23D98149738K23 23D98149754K23 23D98149756K23 23D98149760K23 23D98149761K23 23D98149812K23 23D98149813K23 23D98149818K23 23D98149841K23 23D98149856K23 23D98149859K23 24D98029601A24 24D98034886B24 24D98036930A24 24D98037136A24 24D98037137A24 24D98037139A24 24D98037140A24 24D98037188A24 24D98037283A24 24D98037289A24 24D98037294A24 24D98037300A24 24D98037398A24 24D98037415A24 24D98037567A24 24D98037754A24 24D98037757A24 24D98037759A24 24D98037764A24 24D98037766A24 24D98042105A24 24D98042106A24 24D98042108A24 24D98043355A24 24D98046232A24 24D98046233A24 24D98046235A24 24D98046491A24 24D98046493A24 24D98046494A24 24D98046495A24 24D98046496A24 24D98046497A24 24D98046498A24 24D98046499A24 24D98072439A24 24D98072607A24 24D98072696A24 24D98072904A24 24D98072915A24 24D98072933A24 24D98072935A24 Model 360P Item Number: 360-STR-US-10 UDI-DI Code: 0506016712068 Serial Numbers: 23E90148013K23 24E90003928B24 23E90131693I23 23E90148113K23 24E90020489B24 23E90148518K23 23E90141749K23 24E90018353A24 23E90131752I23 23E90147550K23 23E90147549K23 24E90018363A24 23E90110241H23 23E90131753I23 24E90017316A24 24E90003310B24 23E90135479J23 23E90017678D23 23E90131667I23 23E90103892H23 23E90103894H23 23E90011797D23 23E90107066G23 23E90131427H23 23E90131432H23 23E90006904D23 23E90102226G23 23E90102229G23 23E90131440H23 23E90102659G23 23E90116352H23 23E90148114K23 23E90102210G23 23E90131434H23 23E90148044K23 24E90018361A24 23E90131437H23 23E90137583I23 24E90003983B24 23E90131899I23 23E90006905D23 24E90003492B24 24E90003909B24 23E90102783G23 23E90148066K23 23E90011958D23 23E90145717K23 23E90145714K23 23E90017670D23 23E90131447H23 23E90148035K23 23E90131419H23 23E90017679D23 23E90103889H23 24E90017945A24 23E90147258K23 23E90131413H23 23E90131414H23 23E90103890H23 23E90131900I23 23E90110279H23 23E90131420H23 23E90131896I23 23E90131898I23 23E90131895I23 23E90110826H23 23E90110828H23 23E90110832H23 23E90131438H23 23E90131389H23 23E90107138G23 24E90003893B24 24E90018362A24 24E90017657A24 24E90017483A24 24E90018364A24 23E90110244H23 23E90131748I23 23E90131768I23 23E90011792D23 23E90131904I23 23E90148045K23 23E90107042G23 23E90131448H23 23E90139250I23 24E90018369A24 23E90105485F23 23E90102232G23 23E90107065G23 23E90107068G23 23E90145869K23 23E90145523K23 23E90145475K23 23E90145500K23 23E90102169G23 23E90110286H23 23E90131750I23 23E90131435H23 23E90131431H23 23E90145612K23 23E90147674K23 23E90145484K23 23E90102339G23 23E90130517J23 23E90144000K23 23E90147651K23 23E90145853K23 23E90145852K23 23E90145850K23 24E90017311A24 23E90148014K23 23E90145540K23 23E90006926D23 23E90004982D23 23E90006886D23 23E90006971D23 23E90004978D23 23E90004984D23 23E90006885D23 23E90006964D23 23E90004981D23 23E90006961D23 23E90004983D23 23E90006890D23 23E90006866D23 23E90006910D23 23E90006880D23 23E90004979D23 23E90006970D23 23E90006962D23 23E90006863D23 23E90006968D23 23E90006879D23 23E90006878D23 23E90006884D23 23E90006892D23 23E90006864D23 23E90006903D23 23E90006891D23 23E90006889D23 23E90006893D23 23E90006972D23 23E90006973D23 23E90006907D23 23E90006868D23 23E90006966D23 23E90006930D23 23E90006969D23 23E90006814D23 23E90006815D23 23E90006817D23 23E90006816D23 23E90006813D23 23E90017627D23 23E90017634D23 23E90017628D23 23E90017632D23 23E90017624D23 23E90017636D23 23E90017631D23 23E90017394D23 23E90017735D23 23E90017677D23 23E90017734D23 23E90017392D23 23E90017637D23 23E90017676D23 23E90017674D23 23E90017672D23 23E90017731D23 23E90017675D23 23E90017393D23 23E90017396D23 23E90017395D23 23E90017381D23 23E90017384D23 23E90017382D23 23E90017383D23 Model 450P Item Number: 450-STR-US-10 UDI-DI code: 0506016712069 Serial Numbers: 23G90001569G23 24G90012089B24 24G90012094B24 24G90012120B24 24G90012118B24 23G90006184D23 23G90009052H23 23G90106476K23 23G90006183D23 23G90106676K23 23G90103796J23 23G90003902H23 23G90105515K23 23G90106520K23 23G90106492K23 24G90011087B24 24G90011095B24 23G90107201J23 23G90112607I23 23G90006018D23 23G90105531K23 23G90105573K23 24G90011227B24 23G90110119I23 23G90106011K23 23G90100686K23 23G90106451K23 23G90102992K23 23G90106454K23 23G90106450K23 23G90110201I23 23G90110231I23 23G90100180K23 23G90009404H23 23G90009087H23 23G90009081H23 23G90105399K23 24G90015878A24 23G90008758G23 23G90007502E23 23G90107962K23 23G90102997K23 24G90015874A24 23G90107191J23 23G90107190J23 23G90107195J23 23G90102586J23 23G90107957K23 23G90107393J23 23G90106336K23 23G90008501G23 23G90105667K23 23G90102993K23 23G90106219K23 23G90107945K23 23G90107939K23 23G90112605I23 23G90112599I23 23G90110351I23 23G90110352I23 23G90110348I23 23G90110410I23 23G90112592I23 23G90110127I23 23G90102297K23 24G90016931B24 23G90100548K23 23G90106720K23 24G90015868A24 23G90106449K23 23G90106442K23 23G90106593K23 23G90106591K23 23G90100684K23 23G90106258K23 23G90106261K23 23G90000087H23 23G90000388H23 23G90106033K23 23G90105574K23 23G90110355I23 23G90008634G23 23G90009577H23 23G90109116J23 24G90008247D24 23G90106617K23 23G90106612K23 23G90106619K23 23G90106616K23 23G90106610K23 23G90106601K23 23G90100661K23 23G90100550K23 23G90106684K23 23G90106689K23 23G90101190L23 23G90106645K23 23G90109102J23 23G90106238K23 23G90109029J23 23G90109096J23 23G90105721K23 23G90000296H23 23G90102987K23 23G90003942H23 23G90101215L23 23G90107607J23 23G90107606J23 24G90011267B24 23G90006044D23 23G90112597I23 23G90009414H23 23G90107387J23 23G90107392J23 23G90109373L23 23G90109464L23 23G90107605J23 23G90106830K23 23G90103685L23 23G90101191L23 23G90109047J23 23G90001557G23 23G90001499I23 23G90008538G23 23G90006616G23 24G90001625D24 23G90008434G23 23G90008503G23 23G90008498G23 23G90008435G23 23G90008499G23 23G90008500G23 23G90008436G23 23G90008438G23 23G90008504G23 23G90000094H23 23G90001498I23 23G90112676I23 23G90110125I23 23G90110124I23 23G90112596I23 23G90001698L23 23G90008129L23 24G90011961B24 24G90011770B24 24G90016892B24 24G90001627D24 23G90112598I23 24G90011079B24 24G90011084B24 23G90106377K23 23G90105518K23 23G90105514K23 23G90103206J23 23G90107343J23 23G90107340J23 23G90110088I23 23G90106170K23 23G90108000K23 23G90106543K23 23G90...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Aug 6, 2025
Recall initiation date: Jun 30, 2025
Center classification date: Jul 25, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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