HeartSine 350P, 360P, 450P Defibrillators
HeartSine 350P, 360P, 450P Defibrillators - HeartSine's latest defibrillators with advanced technology for effective cardiac care.
Lower-risk recall
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Contact the company
What happened, in plain English
HeartSine 350P, 360P, 450P Defibrillators - Advanced defibrillators with advanced technology for effective cardiac care. Read more at govinfonow.com/recall/51944-heartsine-350p-360p-450p-defibrillators.
Source Summary by GovInfoNow · govinfonow.com/recall/51944-heartsine-350p-360p-450p-defibrillators · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2174-2025
Cite this page
“HeartSine 350P, 360P, 450P Defibrillators.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51944-heartsine-350p-360p-450p-defibrillators. Based on FDA recall #Z-2174-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2174-2025%22&limit=1).
Why it’s dangerous
None
Who’s affected
All
How to tell if you have this one
HeartSine 350P, 360P, 450P Defibrillators
- Brand
HeartSine- Category
Medical device
What to do — step by step
1
Check the product model and serial number on the device.
2
Verify the serial number matches the list provided for the specific model.
3
Ensure the device is used according to the manufacturer's instructions.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN,…” 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, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the HeartSine 350P defibrillator?
The HeartSine 350P is a portable defibrillator designed for use in emergency situations to treat cardiac arrest.
What are the different models of HeartSine defibrillators?
HeartSine offers several models including the 350P, 360P, and 450P defibrillators, each designed for different use cases and capabilities.
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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-2174-2025 (June 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2174-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.