OVERLOOKED

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Class IIIOngoing

HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator)

Recall date · record updated Oct 7, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
HeartSine Technologies Ltd
Reason
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
Hazard
FDA Class III: not likely to cause adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98483…

Products

  1. 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

    Codes/lots: 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 24DQuantity: 31,834Recall no. Z-3270-2026Class III

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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