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Lower risk Medical device recall · FDA · Published April 26, 2023

HeartSine Defibrillator Pads May Not Work Due to Battery Issues

HeartSine recalls specific defibrillator pads that may fail to analyze or deliver therapy due to depleted battery cells. Affected models include HeartSine Samaritan Public Access Defibrillators with certain serial numbers.

🇺🇸 FDA recall #Z-2143-2023Medical deviceHeartSine ›
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Recalling firmHeartSine Technologies Ltd207 Airport Road West · Belfast, United Kingdom
✎ GovInfoNow plain-language explainer

What happened, in plain English

HeartSine is recalling specific defibrillator pads that may not work properly because the battery cells are depleted. This could prevent the defibrillator from analyzing patient condition or delivering life-saving therapy correctly. Read more at govinfonow.com/recall/58495-heartsine-defibrillator-pads-may-not-work-due-to-battery-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/58495-heartsine-defibrillator-pads-may-not-work-due-to-battery-issues · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2143-2023

Cite this page

“HeartSine Defibrillator Pads May Not Work Due to Battery Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58495-heartsine-defibrillator-pads-may-not-work-due-to-battery-issues. Based on FDA recall #Z-2143-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2143-2023%22&limit=1).

Why it’s dangerous

The single-use battery and electrode cartridges may become inoperable due to depleted battery cells. This could prevent the defibrillator from analyzing patient condition or delivering therapy correctly during a critical cardiac event.

Who’s affected

Public access defibrillators used in emergencies, particularly those with the listed model numbers and serial numbers. Individuals with these specific pads are at risk if the defibrillator fails during a cardiac emergency.

How to tell if you have this one

Check if your HeartSine Samaritan Public Access Defibrillator has model numbers 350P/360P/450P/500P with the specific serial numbers listed in the recall notice. The pads are identified by the model and lot numbers provided in the recall record.

  • Brand
    HeartSine
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Defibrillator Model

    Identify your HeartSine Samaritan Public Access Defibrillator model (350P/360P/450P/500P) and check the serial numbers against the list provided in the recall notice.

  2. Replace Pads

    If your pads match the recalled model and serial numbers, replace them with new, non-recalled pads to ensure proper defibrillator function.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 38 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA & WI and OUS (countries of): Australia, Canada,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Apr 26, 202312. FDA classified it Class II: Jul 13, 202323. Published in FDA’s Enforcement Report: Jul 19, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2143-2023 (April 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2143-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA