Class 2 Device Recall HeartSine

• Date Initiated by Firm: July 27, 2026
• Date Posted: September 04, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3120-2026
• Recall Event ID: 99568
• PMA Number: P160008
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: 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 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).
• Code Information: 350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI codes: 0506016712067 Serial Numbers: 22D91164357L22 22D91164989L22 22D91180808K23 23D98000415K23 23D98000597K23 23D98001134L23 23D98001634I23 23D98001722F23 23D98002004K23 23D98002054K23 23D98002059I23 23D98002086L23 23D98002225K23 23D98002639K23 23D98002649K23 23D98002771L23 23D98002897K23 23D98003187A24 23D98003188L23 23D98003198F23 23D98003221K23 23D98003523K23 23D98004710K23 23D98004956L23 23D98005238E23 23D98005242K23 23D98008495L23 23D98008520K23 23D98008591K23 23D98008832K23 23D98008910E23 23D98009571F23 23D98009597F23 23D98009629I23 23D98009835L23 23D98009905F23 23D98010830K23 23D98012539K23 23D98012748G23 23D98013452K23 23D98013684F23 23D98014324L23 23D98014750K23 23D98014988K23 23D98015098K23 23D98015120K23 23D98015207K23 23D98015221K23 23D98015222K23 23D98015231L23 23D98015571F23 23D98016139F23 23D98016168K23 23D98016187F23 23D98016436K23 23D98016463F23 23D98016490L23 23D98016718K23 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24D98024650H24 24D98019809H24 350P US Device, US English (American Airlines) - 2 Min CPR Item code: 350-STR-AA-AV UDI-DI code: 0506016712207 Serial Numbers: 23D98109359I23 23D98109384I23 23D98110320I23 23D98110321I23 23D98119022J23 23D98119023J23 23D98119024J23 23D98119025J23 23D98119026J23 23D98119027J23 23D98119028J23 23D98119029J23 23D98119030J23 23D98119031J23 23D98119032J23 23D98119033J23 23D98119034J23 23D98119035J23 23D98119036J23 23D98119037J23 23D98119039J23 23D98119040J23 23D98119041J23 23D98119042J23 24D98041472B24 24D98041569B24 24D98041710B24 24D98041712B24 24D98041724B24 24D98041726B24 24D98041729B24 24D98041734B24 24D98041738B24 24D98041746B24 24D98041749B24 24D98041755B24 24D98041758B24 24D98041759B24 24D98041760B24 24D98041765B24 24D98041768B24 24D98041774B24 24D98041781B24 24D98041785B24 24D98041786B24 24D98041801B24 24D98041802B24 24D98041804B24 24D98067144D24 24D98067171D24 24D98067175D24 24D98067179D24 24D98067180D24 24D98067181D24 24D98067182D24 24D98067177D24 24D98067178D24 24D98067183D24 24D98067184D24 24D98067185D24 24D98067186D24 24D98067187D24 24D98067188D24 24D98067189D24 24D98067190D24 24D98067191D24 24D98067192D24 24D98067193D24 24D98067194D24 24D98067195D24 24D98067196D24 24D98067197D24 24D98067198D24 24D98067200D24 24D98067201D24 24D98067202D24 24D98067203D24 24D98067204D24 24D98067205D24 24D98067206D24 24D98067207D24 24D98067208D24 24D98067209D24 24D98067210D24 24D98067211D24 24D98067212D24 24D98067213D24 24D98067214D24 24D98067215D24 24D98067216D24 24D98067217D24 24D98067218D24 24D98067219D24 24D98067220D24 24D98067221D24 24D98067222D24 24D98067223D24 24D98067224D24 24D98067225D24 24D98067226D24 24D98067227D24 24D98067228D24 24D98067229D24 24D98067230D24 24D98067231D24 24D98067232D24 24D98067233D24 24D98067234D24 24D98067235D24 24D98067236D24 24D98067237D24 24D98067238D24 24D98067239D24 24D98067240D24 24D98067241D24 24D98067242D24 24D98067243D24 24D98067244D24 24D98067245D24 24D98067246D24 24D98067247D24 24D98067248D24 24D98067249D24 24D98067250D24 24D98067251D24 24D98067252D24 24D98067253D24 24D98056938D24 24D98067153D24 24D98067155D24 24D98067156D24 24D98067157D24 24D98067158D24 24D98067159D24 24D98067160D24 24D98067161D24 24D98067162D24 24D98067163D24 24D98067164D24 24D98067165D24 24D98067166D24 24D98067167D24 24D98067168D24 24D98067169D24 24D98067170D24 24D98067172D24 24D98067173D24 24D98067174D24 24D98067176D24 24D98067121D24 24D98067131D24 350P US Device, US English with Gateway - 2 Min CPR Item code: 350-STR-US-GW UDI-DI code: 0506016712804 Serial Numbers: 24D98033695E24 24D98033696E24 24D98033711E24 24D98073174E24 24D98033694E24 24D98033688E24 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR Item code: 360-STR-US-10 Serial Numbers: 23E90000585K23 23E90003566K23 23E90004161K23 23E90006888K23 23E90013295K23 23E90013878K23 23E90017687K23 23E90102264G23 23E90102269G23 23E90102273G23 23E90102274G23 23E90102275G23 23E90102279G23 23E90102280G23 23E90102281G23 23E90102282G23 23E90102283G23 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• FEI Number: 3004123209
• Recalling Firm/ Manufacturer: HeartSine Technologies Ltd; 207 Airport Road West; Belfast United Kingdom
• For Additional Information Contact: Joyce Staggs; 425-867-4597
• Manufacturer Reason for Recall: Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
• FDA Determined Cause: Process control
• Action: On 07/28/2026, several versions of an "Urgent: Medical device recall" letter that outlines multiple issues: 1) Stryker identified an issue with the membrane tail, an internal component, which 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) Stryker has also identified that 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. This issue was identified through a customer complaint. For the membrane tail issue (issue 1), Customers are instructed to:
• Quantity in Commerce: 11,912
• Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SD,TN, TX, UT, VA, WA, WI, WV and WY. The countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Hong Kong, Indonesia, ISRAEL, JAPAN, Malaysia, Netherlands, Philippines, POLAND, SINGAPORE, South Korea, Taiwan, Thailand and UNITED KINGDOM.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MKJ