HeartSine AED Recall 2026: How To Check Your Serial Numbers And What Stryker Says To Do Next

A recall notice is not an instruction to take the device off the wall. On this one, the manufacturer is telling owners to do the opposite.

On September 5, 2026, the FDA posted a Class II device recall covering the HeartSine samaritan PAD SAM 350P, SAM 360P and SAM 450P, manufactured by HeartSine Technologies, a Stryker company. Cardiovascular Business reported on September 10 that the action reaches close to 12,000 devices and stems from an internal component known as the membrane tail, which can develop an intermittent fault. According to that coverage, Stryker initiated the action voluntarily after internal quality testing, and no adverse events had been reported at the time of publication.

Stryker's own field action guidance is unusually direct, and it is worth reading before anyone unmounts anything: keep affected units in service until an alternative device is available, verify serial numbers through the manufacturer's product notice page, and perform the documented power-cycle check every three months.

That guidance makes sense once you think about what the alternative looks like. An AED with a low probability of intermittent failure is a better neighbor than an empty cabinet.

What A Class II Recall Actually Means

The word recall does a lot of unhelpful work in ordinary conversation. In FDA terms, a recall is a correction or removal action, and the class describes the level of risk the agency assigns to the problem, not the urgency of ripping the product out of service.

Class I is the most serious classification, used where there is a reasonable probability that the product will cause serious injury or death. Class II covers situations where use may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote. Class III covers situations unlikely to cause adverse health consequences at all.

This action is Class II. It is also a correction rather than a removal, which is the technical reason the manufacturer can instruct owners to keep devices in service while replacements are arranged. None of that makes the notice ignorable. It does mean the correct response is a documented check, not a panic.

Which Devices Are In Scope

The FDA record covers three models in the HeartSine samaritan PAD line: the SAM 350P, the SAM 360P and the SAM 450P. Related field action documentation from Stryker also references the SAM 500P in some markets, and earlier notices in 2025 covered a separate circuit board issue across an overlapping set of models.

That overlap is precisely why you should not decide this from a model number alone. Only a subset of serial numbers is affected, and the authoritative check is the manufacturer's lookup, not a list any reseller maintains. Stryker's HeartSine product notice index is where you enter serial numbers and confirm status:

Stryker HeartSine product notices and serial number lookup

If a device comes back as affected, Stryker's notice directs owners to complete an online acknowledgement form and to download the maintenance supplement, which describes the power-cycle check to run every three months until a replacement arrives.

How To Run The Check Across Multiple Sites In An Afternoon

For a dental office with one unit in the hallway, this is a ten-minute task. For a school district with forty buildings, a hospital campus, a church with three properties, or a city with devices in parks and squad cars, it is a records problem wearing a recall costume.

The work is the same at every scale, just repeated:

Walk the buildings rather than the spreadsheet. Start from a physical list, not an inherited one. Organizations routinely find units nobody recorded, and just as often find a bracket where a unit used to be. Include the places people forget: the bus garage, the auxiliary gym, the field house, the concession stand, the annex.

Record the serial number from the device itself. It is printed on the label on the back or underside of the unit, depending on model. Photograph the label rather than transcribing it; transcription errors are the most common reason a lookup returns nothing.

Run every serial through the manufacturer's lookup. Do them in one sitting so the results are all from the same day and the record is coherent.

Write down the result next to each unit. Affected or not affected, plus the date you checked and who checked it. A recall response that cannot be evidenced later is most of the work with none of the benefit.

For affected units, start the replacement conversation and set the quarterly check. The maintenance supplement check is not optional once a device is identified, and three months is easy to lose track of without a calendar entry that names a person.

The Inventory This Notice Is Really Asking For

Here is the uncomfortable part, and it is the reason this article exists.

The question a recall notice puts to an organization is not which devices are affected. It is whether the organization can produce, today, a written list of every AED it owns, where each one sits, its serial number, its pad and battery expiration dates, and the name of the person responsible for checking it.

Most programs cannot. The devices were bought at different times, by different departments, under different grants, and the person who knew where they all were has usually moved on. That is not negligence; it is what happens to any asset nobody was assigned to track.

A workable AED inventory has six columns and fits on one page per site:

• Site and a specific location, precise enough for someone running. "North corridor, outside room 112, beside the trophy case" rather than "main hallway."
• Manufacturer and model.
• Serial number.
• Pad expiration date.
• Battery or PAD-PAK expiration date.
• Named responsible person, with the date of the last visual check.

Organizations that already had that list spent about ten minutes on this recall. Organizations that did not will spend a week on it, and then spend that week again the next time a notice lands, because notices keep landing. HeartSine alone has been the subject of multiple field actions across 2025 and 2026, including a separate correction on Pad-Pak electrode pads.

What To Tell Your Staff This Week

Three sentences are usually enough for a building-wide email, and getting ahead of the rumor is worth doing:

There is a manufacturer notice on some HeartSine AEDs. The manufacturer's instruction is to leave the device where it is and keep it in service while we verify serial numbers. Do not remove, unplug or relocate any AED, and report the location of any unit not on the posted list.

The last clause is the one that earns its keep. Staff frequently know about devices that facilities does not.

If You Find An Affected Unit

Complete the manufacturer's acknowledgement form, keep the unit in service unless you have another device to put in its place, download the maintenance supplement and diary the three-month check. Then decide, deliberately rather than by default, whether the unit gets replaced on the manufacturer's schedule or sooner because of where it sits. A device covering a football field or a pool deck has a different risk profile than a spare in an administrative office, and that is a judgment for your program, not for a notice.

AED Professionals supplies AEDs, replacement pads and batteries, and AED program management support nationwide. We have carried HeartSine since well before this notice, and if you would like help building or checking a device inventory, our team can walk your list with you. Call 888-541-2337.

Sources

• FDA Medical Device Recalls database, HeartSine Technologies Ltd, Class 2, posted September 5, 2026: accessdata.fda.gov
• Cardiovascular Business, "Stryker recalls AEDs due to malfunction risk," September 10, 2026: cardiovascularbusiness.com
• Stryker, "Updated HeartSine Field Action," July 2026, including the three-month power-cycle check instruction: stryker.com
• Stryker HeartSine product notices index and serial number lookup: stryker.com
• Health Canada recall record describing the membrane tail fault, published July 22, 2026: recalls-rappels.canada.ca