AED Recall List: Current FDA Recalls by Manufacturer

Current AED recalls, newest first

This list covers FDA recalls of AEDs and their pads, batteries and parts in the US since 2017, newest first, with what each one is about and what owners are asked to do. Recalls still marked open are the ones to act on.

The FDA classifies each recall by risk. Class I is a situation where there’s a reasonable probability the product “will cause serious adverse health consequences or death”; Class II, where it may cause temporary or medically reversible health consequences; and Class III, where it’s not likely to cause adverse health consequences.

Recalls of professional monitor/defibrillators, which the FDA files under the same product code, and recalls limited to other countries, such as Defibtech labeling recalls in Switzerland and Ireland, are left out. Search FDA’s Medical Device Recall database for anything older or for a specific model.

Philips AED recalls

Philips HeartStart AEDs and pads have had 11 FDA recall events since 2012, none of them Class I, and two are still open: a 2022 recall of SMART Pads cartridges whose gel can separate, and a 2021 exchange for owners an earlier recall didn’t reach.

The biggest was in 2018, when a resistor issue in HeartStart FRx and HS1 units could prevent a shock; that recall is now closed. The FDA’s AED page also notes a December 2013 safety communication about HeartStart FRx, HS1 Home and HS1 OnSite AEDs made from 2005 to 2012, and a 2017 consent decree between the FDA and Philips over AED manufacturing.

Philips completed the sale of its emergency care business, which includes HeartStart AEDs, on January 8, 2026, and that business now operates as Heartstream. FDA records give Philips’s AED recall line as 1-800-263-3342. There’s no public serial-number lookup, so call with the serial number from the label on the back of the AED. For the SMART Pads recall, unexpired M5071A cartridges with a lot number starting with Y qualify for a free updated cartridge if you respond.

HeartSine AED recalls

HeartSine samaritan PAD AEDs and Pad-Paks have had 11 FDA recall events since 2012, eight of them still open, including two from July 2026. The only Class I event was in 2012, for the older samaritan 300 and 300P.

The open recalls cover an internal fault that can leave the AED unable to charge or shock (2025 and 2026), voice prompts that can stop (2024), Pad-Pak lots with depleted cells (2023) and bent Pad-Pak locator pins (2025), among others. Stryker, which owns HeartSine, now issues HeartSine’s notices.

HeartSine has an online lookup: read the serial number on the back of the AED and enter it at heartsinerecall.com, then complete the acknowledgment form. For the 2025 circuit-board recall, Stryker says to keep using the unit if you have no other AED until it’s replaced. The FDA records list Stryker Customer Service at +1 800 787 9537, option 2.

Stryker and Physio-Control AED recalls

Stryker’s LIFEPAK AEDs, made by Physio-Control, have had 12 FDA recall events since 2012, two of them Class I in 2017, and four are still open. The newest concern units Stryker serviced and infant/child electrodes whose gel can separate.

The 2017 Class I recalls covered LIFEPAK 1000 AEDs that could power off during use, and infant/child electrodes printed with the wrong placement artwork; both are closed. Open recalls cover LIFEPAK 1000 and CR2 units whose post-service inspection wasn’t documented (2025 and 2026), infant/child reduced-energy electrodes (2026) and LIFEPAK CR2 units with a missing lid magnet that can drain the battery (2021).

Stryker has no public serial lookup for LIFEPAK recalls: it mails affected owners a letter with a reply form, returned to RSRecall@stryker.com. Its product notices page lists current notices, and Customer Service is 1-800-787-9537, option 2.

Cardiac Science AED recalls

Cardiac Science Powerheart AEDs and pads have had 5 FDA recall events since 2012, and ZOLL, which now owns the line, filed the two that are still open, both for the Powerheart G5. The one Class I event, in 2012, covered the Powerheart G3 and versions sold under other brands.

The 2012 Class I recall covered Powerheart G3 AEDs and their OEM versions, including the CardioVive, GE Responder and Nihon Kohden CardioLife, because a defective circuit-board component could stop the AED from shocking. The open G5 recalls cover a self-test failure (Error Code 501) after storage outside the specified temperature and humidity, and shipping film that can block the shock button on semi-automatic units.

There’s no serial lookup for these. ZOLL’s Powerheart G5 correction page has the customer letter and an acknowledgment form, and the notice tells owners to watch self-test results and store the AED between 32°F and 122°F and 10 to 95 percent humidity. ZOLL technical support is 1-800-348-9011.

Defibtech AED recalls

Defibtech has had 5 FDA recall events since 2012, none Class I. In the US, the latest was in 2023, for 29 Lifeline DDU-100 units with an untested component; its other open records apply only outside the US.

In 2020, a component issue in the Lifeline VIEW, PRO and ECG could abort a shock or reset the AED; that recall is closed. Defibtech’s 2020 safety alert page has a serial-number checker: take the pads out of the storage pouch on the back of the AED to find the nine-digit serial label. Later notices went to owners by email with serial lists, and Defibtech lists all of them on its product notices page.

ZOLL AED recalls

ZOLL’s own AEDs have had one FDA recall event since 2012, a 2019 recall of the AED Pro, and none for the AED Plus or AED 3. A 2017 Class I recall did cover third-party Skintact pads sold for the ZOLL AED Plus.

The AED Pro recall concerns a possible failure to deliver energy, and the FDA’s record doesn’t include instructions for owners, so contact ZOLL if you own one. The 2017 recall covered Leonhard Lang Skintact DF59N and DF59NC electrodes, which could connect late or not at all to a ZOLL AED Plus; it’s closed. ZOLL’s product notices page lists its current notices, and technical support is 1-800-348-9011. Since ZOLL acquired Cardiac Science, the Powerheart G5 recalls above are ZOLL’s too.

How to check whether your AED’s serial number is affected

Find the serial number on the AED’s label, check it against the manufacturer’s lookup or call the manufacturer, and look up your model in FDA’s recall database. If you register your AED with the manufacturer, recall letters come to you.

1. Find the serial number. It’s on the label on the back or bottom of most AEDs; on Defibtech units, remove the pads from the pouch on the back to see it.
2. Use the lookup, if there is one. HeartSine and Defibtech have online serial checks. For Philips, Stryker and ZOLL, call with the serial number ready.
3. Search FDA’s database by model name. Each recall record lists the affected models and often the serial or lot ranges.
4. Check accessories too. Pad and Pad-Pak recalls go by lot number, printed on the package.
5. Record the result for each unit, affected or not, with the date and the recall number.

The American Heart Association’s guide to AED programs recommends registering each AED with its manufacturer, so you receive news of updates and recalls. Avive’s AEDs had no FDA recall records when we checked.