HeartSine PAD Recall 2026: Easy Serial Number Check Without Wall Removal
Short answer: Stryker has issued a field action covering roughly 12,000 HeartSine samaritan PAD 350P, 360P and 450P defibrillators over an internal component that may malfunction during charging or shock delivery. Stryker is asking owners to keep affected units in service until a replacement is in place. Check your serial numbers against the manufacturer's product notice. Do not take the device off the wall.
If your building has a HeartSine samaritan PAD mounted on the wall, this is a serial-number week. Not a remove-the-device week. Those two things get confused constantly, and on this particular notice the difference matters more than usual.
Here is what the field action covers, how to check whether your units are affected, and what to do with the answer.
What The Field Action Covers
Stryker is recalling approximately 12,000 HeartSine samaritan PAD units across three models: the 350P, the 360P and the 450P. The issue is an internal component called the membrane tail, which may malfunction during charging, during shock delivery, or immediately after a shock is delivered.
Cardiovascular Business reported on September 10, 2026 that the FDA classified the action as Class II, and that Stryker identified the defect through its own internal quality testing. Stryker states that no adverse events have been linked to it.
| Item | Detail |
|---|---|
| Affected models | HeartSine samaritan PAD 350P, 360P, 450P |
| Approximate units | 12,000 |
| Component | Membrane tail, internal |
| When it may present | During charging, during shock delivery, or immediately after a shock |
| Field action reference | PR3977961-FA318 / FA319, per distributor notices circulated from August 16, 2026 |
| Owner instruction | Keep affected units in service until a replacement or alternative device is in place |
| What you need to check | The serial number on each unit, against the manufacturer's product notice |
Why Stryker Is Telling Owners To Keep Units In Service
This is the instruction most people will get wrong, so it is worth stating plainly. Stryker is directing affected owners to leave the device where it is until a replacement or an alternative device is available.
That runs against instinct. A facilities director who hears the word recall pulls the device off the wall the same afternoon. It feels like the cautious move. On a notice like this one it is not, because it trades a low-probability internal defect for a guaranteed absence.
An empty cabinet has a failure rate of one hundred percent. A device with a component that may malfunction during charging or shock delivery still has a very good chance of delivering therapy, and it still prompts a bystander to call 911, start compressions and follow the voice. Removing it removes all of that.
This is the reasoning behind the instruction as the manufacturer has written it. Follow the manufacturer's direction on your specific units rather than a general rule of thumb, and if the notice for your serial numbers says something different from what you read here, the notice governs.
How To Find Your Serial Number On A samaritan PAD
The serial number is on the label on the back of the device. You do not need to open anything, disconnect anything, or remove the Pad-Pak to read it. Take the unit off the bracket, read the label, put it back.
A few practical notes from doing this across multi-site accounts:
- The Pad-Pak has its own serial number. The Pad-Pak is the combined battery and electrode cartridge, and its number is not the device serial number. The field action is about the device.
- Photograph the label. One photo per unit, with the room or building in the filename. This saves the second trip that otherwise always happens.
- Check every unit, not a sample. Organizations buy AEDs in batches over years. Two devices in the same building can be four years apart in manufacture and land on opposite sides of the affected range.
- Include the devices nobody thinks of. The one in the vehicle, the one in the gym bag for away games, the one in the second building that the facilities list calls storage.
Then check each number against Stryker's HeartSine product notice page. Note that the Stryker product-notice URL currently forwards to a dedicated notice portal, so do not be alarmed when the address changes in your browser.
Stryker HeartSine product notice and serial-number lookup
What To Do If Your Unit Is Affected
Three steps, in this order.
Document the check. Write down the date you checked, the serial number, the result, and who checked it. This is the record that answers the question a year from now when someone asks whether this was ever handled. A line in a spreadsheet is enough. An email to yourself is enough. Nothing written down is not enough.
Get affected units into the replacement queue. Follow the process in the notice for your units. If the devices were bought through a distributor rather than direct, the distributor is often the faster path, because the manufacturer notice may never have reached your organization's current contact.
Consider interim coverage for high-traffic locations. A gym floor, a school building at dismissal, a plant at shift change, a church on a Sunday morning. If a site carries a high volume of people and has a single affected device, a second unit on site during the replacement window is a reasonable decision. That is a program judgment, not a requirement, and it is worth making deliberately rather than by default.
The Larger Lesson: Your Inventory Is The Real Finding
Here is the pattern we see every time a notice like this goes out. The notice itself is a twenty-minute task for an organization that has an accurate AED inventory, and a two-week scramble for an organization that does not.
The reason is not complicated. To act on a field action you need to know how many devices you own, what model each one is, what its serial number is, and where it physically sits. Most organizations can answer the first question and stall on the rest. The person who bought the devices has left. The purchase ran through a distributor in 2019. The list, if it exists, is in a spreadsheet nobody has opened since 2023.
A working AED inventory holds six fields per device:
| Field | Why it earns its place |
|---|---|
| Make and model | Tells you in ten seconds whether a notice applies to you at all |
| Serial number | The only field that answers a field action |
| Exact location | Building, floor, and the sentence you would say to a bystander |
| Pad expiration | The most common reason a device fails at the moment of use |
| Battery expiration | Same, and it moves independently of the pads on some models |
| Purchase date and source | Tells you who should have notified you, and who can replace it fastest |
On a HeartSine, the Pad-Pak combines battery and electrodes into a single dated cartridge, which simplifies two of those rows into one. That is a genuine advantage of the platform and a reason the samaritan PAD is so common in schools, churches, dental offices, gyms and small manufacturing sites in the first place.
How AED Program Management Handles This For You
The reason AED program management exists as a service is precisely this week. Someone has to be the party that receives the manufacturer notice, holds the serial numbers, knows which of your sites are affected, and tells you the answer rather than asking you to go find it.
A program review covers the same ground you would cover yourself, in one pass: a device-by-device inventory with serial numbers, pad and battery expiration dates loaded against a calendar, registration with local dispatch, training records and refresh dates, medical direction where your state requires it, and a post-event data process so that a real use produces a usable record.
We have specialized in AEDs since 2003, and this is our only business. If you want a second set of eyes on your inventory, or you would like help reading a serial number off a device you are looking at right now, call us at 888-541-2337.
Related Reading
- ANSI/ISEA Z308.1-2026: What The Updated First Aid Standard Means For Your AED Program
- Is Your AED On The Map? How AED Registration Connects Your Device To 911
Sources And Further Reading
- Cardiovascular Business, September 10, 2026 ā Stryker recalls AEDs due to malfunction risk
- Stryker ā HeartSine samaritan PAD product notice and serial-number lookup
- MedAire distributor notice, August 16, 2026 ā Updated recall notice, HeartSine samaritan PAD 350P, 360P, 450P
This article explains a manufacturer field action and how to check your own equipment. It is not a substitute for the manufacturer's instructions for use or for the field action notice itself, and it is not medical guidance. Always follow the instructions issued by the manufacturer for your specific serial numbers, and make sure the people expected to use an AED have current training.