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Ongoing FDAEvent 98483 (20 days ago)

HeartSine Samaritan PAD Public Access Defibrillators

HeartSine samaritan PAD defibrillators were distributed without the required Maintenance Supplement.

Low risk

Using it is unlikely to cause health problems.

FDA Class III recall · How risk is rated

What to do

What happened

HeartSine Technologies Ltd recalled HeartSine samaritan PAD (Public Access Defibrillator) models SAM 350P, SAM 360P, and SAM 450P because the products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check. The recall began July 27, 2026, and was added to the FDA's Enforcement Report on September 25, 2026.

Summary by Recall Canary from the FDA notice.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its UDI-DI is listed.

  1. 350P US Device, US English - 2 Min CPR

    UDI-DI
    • 0506016712067

  2. 350P US Device, US English (American Airlines) - 2 Min CPR

    UDI-DI
    • 0506016712207

  3. 350P US Device, US English with Gateway - 2 Min CPR

    UDI-DI
    • 0506016712804

  4. 360P US Device, US English - 2 Min CPR

    UDI-DI
    • 0506016712068

  5. SAM 450P US Device, US English (2 min CPR)

    UDI-DI
    • 0506016712069

Details

Company began the recall
Sold in

U.S. Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, GU, 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, and Wyoming.

Event ID
98483
Recall No.
Z-3270-2026
Company
HeartSine Technologies LtdBelfast, United Kingdom
Hazard
Device defect

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

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Summary by Recall Canary, written with AI · summary updated Oct 8, 2026 · primary source: U.S. Food and Drug Administration