HeartSine Technologies Ltd recalls HeartSine samaritan PAD

Recalling company

HeartSine Technologies Ltd

Product

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

Reason

Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

Classification

Class III – not likely to cause adverse health consequences

Recall date

Jul 27, 2026

Reported

Oct 7, 2026

Distribution

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.

Status

Ongoing

Quantity

31,834

Lot / codes

Product - 350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers: 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 24D

Company location

Belfast

Recall type

Voluntary: Firm initiated

Recall number

Z-3270-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3270-2026 in the FDA Enforcement Report. Also see FDA recall press releases.