Reported Sep 16, 2026 · Ongoing
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English…
HeartSine Technologies Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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
Is this the product you have?
- 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 The HeartSine samaritan� PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest
- who are exhibiting the following signs" Unconscious " Not breathing " Without circulation (without a pulse) The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02)
- Lot codes and dates
- 350P US Device
- US English - 2 Min CPR Item code350-STR-US-10
- UDI-DI codes0506016712067
- Serial NumbersUS Device, US English (American
1,645 of 1,645 codes
22D91164357L2222D91164989L2222D91180808K2323D98000415K2323D98000597K2323D98001134L2323D98001634I2323D98001722F2323D98002004K2323D98002054K2323D98002059I2323D98002086L2323D98002225K2323D98002639K2323D98002649K2323D98002771L2323D98002897K2323D98003187A2423D98003188L2323D98003198F2323D98003221K2323D98003523K2323D98004710K2323D98004956L2323D98005238E2323D98005242K2323D98008495L2323D98008520K2323D98008591K2323D98008832K2323D98008910E2323D98009571F2323D98009597F2323D98009629I2323D98009835L2323D98009905F2323D98010830K2323D98012539K2323D98012748G2323D98013452K2323D98013684F2323D98014324L2323D98014750K2323D98014988K2323D98015098K2323D98015120K2323D98015207K2323D98015221K2323D98015222K2323D98015231L2323D98015571F2323D98016139F2323D98016168K2323D98016187F2323D98016436K2323D98016463F2323D98016490L2323D98016718K2323D98016725K2323D98017989L23
- Airlines) - 2 Min CPR Item code350-STR-AA-AV
- UDI-DI code0506016712207
- Serial NumbersUS Device, US English
152 of 152 codes
23D98109359I2323D98109384I2323D98110320I2323D98110321I2323D98119022J2323D98119023J2323D98119024J2323D98119025J2323D98119026J2323D98119027J2323D98119028J2323D98119029J2323D98119030J2323D98119031J2323D98119032J2323D98119033J2323D98119034J2323D98119035J2323D98119036J2323D98119037J2323D98119039J2323D98119040J2323D98119041J2323D98119042J2324D98041472B2424D98041569B2424D98041710B2424D98041712B2424D98041724B2424D98041726B2424D98041729B2424D98041734B2424D98041738B2424D98041746B2424D98041749B2424D98041755B2424D98041758B2424D98041759B2424D98041760B2424D98041765B2424D98041768B2424D98041774B2424D98041781B2424D98041785B2424D98041786B2424D98041801B2424D98041802B2424D98041804B2424D98067144D2424D98067171D2424D98067175D2424D98067179D2424D98067180D2424D98067181D2424D98067182D2424D98067177D2424D98067178D2424D98067183D2424D98067184D2424D98067185D24
- with Gateway - 2 Min CPR Item code350-STR-US-GW
- UDI-DI code0506016712804
- Serial Numbers24D98033695E24 24D98033696E24 24D98033711E24 24D98073174E24 24D98033694E24 24D98033688E24 HeartSine SAM 360P 360P US Device
- US English - 2 Min CPR Item code360-STR-US-10
- Serial Numbers3
342 of 342 codes
23E90000585K2323E90003566K2323E90004161K2323E90006888K2323E90013295K2323E90013878K2323E90017687K2323E90102264G2323E90102269G2323E90102273G2323E90102274G2323E90102275G2323E90102279G2323E90102280G2323E90102281G2323E90102282G2323E90102283G2323E90102284G2323E90102285G2323E90102286G2323E90102287G2323E90102288G2323E90102289G2323E90102290G2323E90102291G2323E90102292G2323E90102293G2323E90102294G2323E90102295G2323E90102296G2323E90102297G2323E90102298G2323E90102299G2323E90102300G2323E90102303G2323E90102304G2323E90102305G2323E90102306G2323E90102307G2323E90102308G2323E90102309G2323E90102312G2323E90102313G2323E90102314G2323E90102315G2323E90102316G2323E90102317G2323E90102318G2323E90102319G2323E90102320G2323E90102321G2323E90102406G2323E90102411G2323E90102539G2323E90102540G2323E90102542G2323E90102543G2323E90102586G2323E90102587G2323E90102601G23
HeartSine SAM 450P SAM 450P US Device2,014 of 2,014 codes
23E90146441J2323E90146442J2323E90146443J2323E90146445J2323E90146446J2323E90146450J2323E90146451J2323E90146452J2323E90146453J2323E90146454J2323E90146455J2323E90146566J2323E90148086K2323E90148149K2323E90148170K2323E90148173K2323E90148291K2323E90148293K2323E90148297K2323E90148301K2324E90001961B2424E90002370B2424E90003112B2424E90003215B2424E90003216B2424E90003254B2424E90003312B2424E90003493B2424E90003494B2424E90003739B2424E90003744B2424E90003745B2424E90003747B2424E90003760B2424E90003787B2424E90003791B2424E90004170B2424E90004612B2424E90004613B2424E90004617B2424E90004619B2424E90004621B2424E90004622B2424E90004624B2424E90004625B2424E90004633B2424E90004634B2424E90004635B2424E90004638B2424E90004640B2424E90004641B2424E90004695B2424E90004696B2424E90004697B2424E90004698B2424E90004699B2424E90004704B2424E90004705B2424E90004706B2424E90004726B24
- US English (2 min CPR) Item code450-STR-US-10
- UDI-DI code0506016712069
- Serial Numbers
2,988 of 2,988 codes
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
- Amount recalled
- 11,912
Where it was sold
Why it was recalled
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
This product could cause temporary or reversible health problems — stop using it.
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