HeartSine samaritan PAD (Public Access Defibrillator)
Medical device recall Z-3270-2026. Published in FDA’s Enforcement Report on Oct 7, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 7, 2026. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 48 states named
- 31,834 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
31,834, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,992 characters
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 24D98070127F24 24D98070128F24 24D98070129F24 24D98070130F24 24D98070132F24 24D98070133F24 24D98070134F24 24D98070135F24 24D98070136F24 24D98070138F24 24D98070139F24 24D98070140F24 24D98070141F24 24D98070143F24 24D98070144F24 24D98070145F24 24D98070148F24 24D98070149F24 24D98070150F24 24D98070151F24 24D98070157F24 24D98070160F24 24D98070161F24 24D98070162F24 24D98070163F24 24D98070166F24 24D98056785D24 24D98057279D24 24D98057648D24 24D98053900E24 24D98054669E24 24D98054543E24 24D98054034E24…
FDA’s list runs to 81,248 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
48 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 27, 2026.
- FDA classified it on Sep 25, 2026.
- FDA’s Enforcement Report published it on Oct 7, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- HeartSine Technologies Ltd, of Belfast, United Kingdom.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 81,248 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.