Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI…
HeartSine Technologies Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HeartSine Technologies Ltd · 207 Airport Road West · Belfast · N/A
Is this the product you have?
- HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device
- US English - 2 Min CPR UDI-DI codes0506016712067 350P US Device, US English (American
- Airlines) - 2 Min CPR UDI-DI code0506016712207 350P US Device, US English
- with Gateway - 2 Min CPR UDI-DI code0506016712804 HeartSine SAM 360P 360P US Device
- US English - 2 Min CPR UDI-DI code0506016712068 HeartSine SAM 450P SAM 450P US Device
- US English (2 min CPR) UDI-DI code0506016712069
- Lot codes and dates
- Product - 350P US Device
- US English - 2 Min CPR Item code350-STR-US-10
- UDI-DI code0506016712067
- Serial NumbersProduct - 350P US Device, US English (American
668 of 668 codes
24D98056051D2424D98057467D2424D98057468D2424D98057469D2424D98068091E2424D98068097E2424D98070022F2424D98070023F2424D98070024F2424D98070025F2424D98070026F2424D98070027F2424D98070028F2424D98070029F2424D98070030F2424D98070031F2424D98070032F2424D98070033F2424D98070034F2424D98070035F2424D98070036F2424D98070037F2424D98070038F2424D98070040F2424D98070041F2424D98070042F2424D98070043F2424D98070046F2424D98070047F2424D98070048F2424D98070049F2424D98070050F2424D98070051F2424D98070052F2424D98070053F2424D98070054F2424D98070055F2424D98070056F2424D98070057F2424D98070058F2424D98070060F2424D98070061F2424D98070062F2424D98070063F2424D98070064F2424D98070065F2424D98070066F2424D98070068F2424D98070069F2424D98070071F2424D98070072F2424D98070074F2424D98070075F2424D98070076F2424D98070077F2424D98070078F2424D98070079F2424D98070080F2424D98070081F2424D98070082F24
- Airlines) - 2 Min CPR Item code350-STR-AA-AV
- UDI-DI code0506016712207
- Serial NumbersProduct - 350P US Device, US English
103 of 103 codes
24D98067253D2424D98067252D2424D98067251D2424D98067249D2424D98056938D2424D98067250D2424D98067248D2424D98067153D2424D98067160D2424D98067155D2424D98067163D2424D98067180D2424D98067182D2424D98067219D2424D98067186D2424D98067220D2424D98067221D2424D98067215D2424D98067156D2424D98067200D2424D98067195D2424D98067242D2424D98067231D2424D98067234D2424D98067244D2424D98067197D2424D98067232D2424D98067194D2424D98067166D2424D98067165D2424D98067161D2424D98067169D2424D98067241D2424D98067162D2424D98067192D2424D98067159D2424D98067198D2424D98067157D2424D98067203D2424D98067191D2424D98067158D2424D98067246D2424D98067225D2424D98067247D2424D98067206D2424D98067173D2424D98067204D2424D98067213D2424D98067209D2424D98067187D2424D98067207D2424D98067178D2424D98067217D2424D98067214D2424D98067222D2424D98067189D2424D98067212D2424D98067171D2424D98067170D2424D98067177D24
- with Gateway - 2 Min CPR Item code350-STR-US-GW
- UDI-DI code0506016712804
- Serial Numbers24D98073174E24 24D98033695E24 24D98033694E24 24D98033696E24 24D98033711E24 24D98033688E24 24D98033686E24 Product - 360P US Device
- US English - 2 Min CPR Item code360-STR-US-10
- UDI-DI code0506016712068
- Serial Numbers
1,362 of 1,362 codes
24E90017943A2424E90016508A2424E90017446A2424E90017448A2424E90017447A2424E90016896A2424E90017445A2424E90017444A2424E90017664A2424E90017257A2424E90017482A2424E90017492A2424E90017662A2424E90017479A2424E90017488A2424E90017661A2424E90017480A2424E90017307A2424E90017659A2424E90017490A2424E90017481A2424E90017486A2424E90017665A2424E90017663A2424E90017258A2424E90017308A2424E90017484A2424E90017489A2424E90017656A2424E90017309A2424E90017224A2424E90017226A2424E90016745A2424E90016512A2424E90017143A2424E90017134A2424E90017136A2424E90018007A2424E90017956A2424E90017954A2424E90017955A2424E90017950A2424E90017940A2424E90017948A2424E90017947A2424E90017937A2424E90017941A2424E90017938A2424E90017942A2424E90017939A2424E90017946A2424E90017995A2424E90017990A2424E90018001A2424E90017993A2424E90017978A2424E90018341A2424E90017985A2424E90018327A2424E90018345A24
- Amount recalled
- 31,834
Where it was sold
Why it was recalled
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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