AED recalls & notices

Which devices this covers

This action was announced in Stryker's updated HeartSine field action of July 2026 and is recorded by Health Canada as recall RA-82380 (Type II), with a recall date of 13 July 2026. It covers ten catalogue variants — four of the SAM 350P, four of the SAM 360P and two of the SAM 500P — limited to specific lot numbers, which Stryker supplies on request.

Why this is separate from the serial number recall

This is not the same action as the circuit board recall below, and the two do not share a checking method. A defibrillator that came back clear on the serial number lookup has been cleared of the circuit board defect only — it can still fall within an affected membrane tail lot. Both need to be checked.

What this means for your defibrillator

The fault is intermittent, which means a defibrillator that passes its self-test today can still fail at the moment it is needed. That makes this one to act on rather than watch. Have the lot number checked and complete the acknowledgement form so the device is on record with the manufacturer.

HeartSine Technologies / Stryker Australia: 1800 738 521.

What to do next

1. Find the lot number on the label on the rear of the defibrillator.
2. Telephone Stryker on 1800 738 521 and have the lot number checked against the affected list.
3. Complete the online acknowledgement form on the HeartSine product notice site.
4. Check the serial number separately against the circuit board recall below — clearing one does not clear the other.

Which devices this covers

Affected units carry a serial number beginning 21, 22, 23 or 24, followed by the letter B, D, E, G or H. The manufacturer's reference for this action is FA318-T3. It was issued in June 2025 and the field action was updated in July 2026.

Is this one mine?

• The model name is printed on the front of the device; the model and serial number are on the label on the rear.
• The 360P is fully automatic and has no shock button; the 350P and 500P each have one.

What has actually been found

The problem was identified in the manufacturer's own quality testing rather than in patient use, and no adverse events have been reported. Stryker's advice is to keep an affected device in service if you have no alternative defibrillator available, on the basis that internal testing shows a low probability of failure.

What this means for your defibrillator

Completing the online acknowledgement form is what places the device in the replacement queue. Replacement supply has been delayed, and all replacement units are expected to be supplied by 31 May 2027 — so a device registered now may remain in service for some time. Keep it maintained and checked in the meantime.

This recall, the membrane tail recall above and the Pad-Pak notices below are all separate actions with separate checks. A device that is clear on its serial number can still have an affected Pad-Pak fitted.

What to do next

1. Check your defibrillator's serial number against Stryker's recall lookup.
2. If affected, register the device and provide shipping details.
3. Keep the defibrillator in service until your replacement arrives, unless Stryker tells you otherwise.

Which devices this covers

This forms part of Stryker's updated HeartSine field action of July 2026 and applies to devices distributed without the supplement. There is nothing wrong with the defibrillator itself under this item — the shortfall is in the documentation supplied with it, and in the routine check that documentation sets out.

What the missing check actually is

Power the defibrillator on and off once every three months and listen for the expected voice prompts. Its purpose is to detect the missing voice prompt defect covered by the notice below, which the device's own automatic self-test does not pick up. That is why this item matters more than a missing pamphlet normally would.

What this means for your defibrillator

The documentation stored with a defibrillator forms part of what a workplace inspection looks at, so replace or add the stored copy and record the date you did so. Then start the three-monthly check and keep a record of each one — a documented check is what shows the action is being managed.

What to do next

1. Download the maintenance supplement from the HeartSine product notice site.
2. Store it with the user manual kept alongside the defibrillator.
3. Carry out the power-cycle check every three months and record the date and result.
4. Contact Stryker on 1800 738 521 if you would like a printed copy sent.

Which devices this covers

The TGA published this as a product correction on 23 April 2025 under reference RC-2024-RN-00356-1, covering the SAM 350P, 360P and 500P. Stryker is still trying to reach a small number of customers it cannot identify, so no closing date applies. The same manufacturing problem is recorded in the United States as FDA recall Z-1820-2024, Class 2, initiated on 8 April 2024 and covering 183,248 units in commerce; the FDA still records that recall as not complete.

Where the two regulators differ

The Australian action lists the SAM 350P, 360P and 500P. The United States record lists the SAM 350P, 360P and 450P, and its distribution is recorded as the United States only. The models shown above follow the Australian action, because that is the one that governs devices supplied here. If you hold a 450P, the check below takes a minute and is worth doing regardless — the fault it looks for is the same one.

What this means for your defibrillator

The device's automatic self-test does not detect this fault, and the status indicator will keep showing ready. The only way to find it is to power the device on and listen. That is precisely the check set out in the maintenance supplement covered by the notice above — the two items belong together.

What to do next

1. Power the defibrillator on and off every three months and listen for the expected voice prompts.
2. If prompts are missing or incomplete, remove the device from service and report it to Stryker on 1800 738 521.
3. Record each check and its result alongside your other defibrillator maintenance records.

Which devices this covers

This correction applies to the BeneHeart D1 only. It does not apply to the BeneHeart C1A or C2 — those models have their own product correction, listed below.

What has actually changed

Only the operator's manual has changed — there is no repair, replacement or change to the device itself, and it remains in normal service. The updated wording directs users to check the patient type shown on the defibrillator and correct it if it does not match the patient, and notes that once MR60 or MR61 electrode pads are connected to both the defibrillator and the patient, the device switches to adult mode. The device already defaults to adult mode and announces and displays the current patient type. Mindray reports no injuries from this problem.

What this means for your defibrillator

The manual stored with the device is part of what a workplace inspection looks at, so replace the stored copy with the revised edition, record the date you did so, and make sure anyone trained on the unit knows to confirm the displayed patient type before delivering a shock.

What to do next

1. Obtain and review the revised operator's manual.
2. Before use, check that the displayed patient type matches the patient.
3. If it does not, manually select the correct patient type.

Which devices this covers

The BeneHeart C1A, C1A Fully Automatic, C2 and C2 Fully Automatic. No serial number range has been specified, so treat every C Series unit as within scope. The BeneHeart D1 correction above is a different product and a different action — neither replaces the other. The photograph shows the C2; the C1A is the compact model, with a small status display in place of the colour screen.

What has actually changed

Devices configured with Wi-Fi or cellular connectivity enabled transmit their self-test reports by default, consuming additional battery power each time. In certain network configurations this can shorten battery life, and a low battery may cause the device to fail to power on, delaying therapy. The operator's manual has also been updated to make clear that the defibrillator verifies new electrode pads are attached before it shuts down, and shows a red flashing status light if they are missing.

What this means for your defibrillator

The device remains safe to deploy and stays in routine service — this is a correction, not a return. The risk is a slow one: the battery is consumed faster than the maintenance schedule assumes, so a unit that looked fine at its last check can be flat at the next. If a defibrillator sits on a wall with connectivity switched on and nobody reads the reports it sends, the reporting is costing battery life for no benefit and is worth turning off.

Mindray Medical Australia: 1800 793 011 · service.au@message.mindray.com

What to do next

1. Obtain the updated operator's manual and replace the copy stored with the device.
2. Check the status indicator now, and replace the battery immediately if the low battery indicator is showing.
3. Contact Mindray to disable automatic Wi-Fi or cellular self-test reporting where it is not being used.
4. Make sure new electrode pads are connected before the device is powered down.

Which cartridges this covers

The United States record for this same action is FDA recall Z-0288-2026, initiated on 18 September 2025 and posted on 23 October 2025; it is cited as FA327 in distributor notices. That record lists the Americas and Japanese catalogue numbers — PAD-PAK-01, -02, -03, -04, -07, -03J and -04J — which are the same products as the Australian numbers shown above under different regional part numbers. 1,291,165 units were in commerce worldwide, Australia included.

Pad-Paks shipped from 6 October 2025 onwards are not affected. The affected cartridges fall within a wide expiry window running to 1 August 2029, so a long expiry date is not by itself reassurance — the part number and lot number printed on the cartridge are what decide it.

What this means for your defibrillator

A HeartSine defibrillator can fail on the cartridge alone while the device itself is sound. A device that came back clear on the serial number lookup can still have an affected Pad-Pak fitted, so check the cartridge separately. If you replace a Pad-Pak, check the new cartridge before fitting it — replacement stock purchased recently can still carry an affected lot number.

What to do next

1. Check the Pad-Pak expiry date: 17 Apr 2025–1 Aug 2029.
2. Remove it and inspect the locator pins.
3. If bent, set it aside and arrange a replacement with Stryker. If straight, reinstall it correctly.

Background to this action

This recall originally commenced in August 2023 (TGA reference RC-2023-RN-00695-1; recorded by Health Canada as RA-73672, Type II, with a recall start of 3 May 2023) and was renewed in late 2025 because Stryker is still attempting to reach a small percentage of owners it has not been able to identify. An affected Pad-Pak may fail to power the defibrillator when it is needed, preventing it from analysing the patient or delivering therapy.

Where to find the lot number

The REF part number and LOT number are printed together in the blue panel on the rear of the cartridge, as shown in the photograph above. The grey cartridge is the adult Pad-Pak; the pink cartridge is the paediatric version.

What this means for your defibrillator

Continue monitoring the device between checks: the status indicator should flash green every five to ten seconds. Contact Stryker immediately if the indicator flashes red or the device beeps continuously.

Stryker replacement arrangements: postmarketssp@stryker.com or (02) 9170 9162.

What to do next

1. Check the lot number printed on your Pad-Pak against the affected list.
2. If affected, contact Stryker for a replacement.
3. Continue monitoring the AED status indicator until the replacement is fitted.

Why this one is different

Every CellAED unit is covered — there is no serial number to check and no subset that falls outside the recall. Because the supplier is in liquidation, there is no manufacturer left to service the device, and the Therapeutic Goods Administration's instruction is direct: do not use it.

What this means for your site

If a CellAED was the defibrillator covering your site, the site is currently without cover — that is the part to act on today. Remove the unit physically so nobody reaches for it in an emergency, take it off your defibrillator register and any site map or evacuation diagram that shows it, and tell everyone who was trained on it or told where it was. Treat the site as uncovered until a working defibrillator is in place.

Refunds are a matter for the liquidator. Owners are treated as unsecured creditors, so recovering the purchase price is unlikely. The unit contains a lithium battery and must not go into general waste.

What to do next

1. Do not use the CellAED.
2. Arrange safe disposal through an approved waste facility or licensed waste specialist.
3. There is no replacement stock available through the recall.

What the alert says

ZOLL Medical Australia, in consultation with the Therapeutic Goods Administration, issued this Product Alert (reference RC-2025-RN-00298-1). Globally, ZOLL has received 2,225 field reports involving 1,855 devices displaying Error Code EC 501 after self-tests. ZOLL is aware of one death, outside the United States, where a device had failed its self-test and this was not detected before the device was needed. In every other known case, the failure was picked up during routine inspection and the device was replaced in time.

The affected list includes the configurations supplied through St John — CSG5-Pack, CSG5CPR-Pack, CSG5S-Pack and CSG5SCPR-Pack — as well as other G5 models.

Is this one mine?

• Orange case with a black carry handle and a round Rescue Ready indicator at the top — green means the last self-test passed.
• POWERHEART G5 is printed on the front label. Many units in Australia were supplied through St John.
• The semi-automatic model has a shock button; the fully automatic model does not.

What this means for your defibrillator

This is not a return-all-units recall — the device tells you when it has failed. The danger sits entirely with sites where nobody looks: the one known death occurred because a failed self-test went unnoticed. A G5 whose indicator is checked regularly, and acted on, is operating exactly as the manufacturer intends.

ZOLL recommends preventive maintenance at least monthly, and the device should be stored between 0°C and 50°C at 10% to 95% humidity (non-condensing) — storage outside those conditions is the suspected cause.

What to do next

1. Check the Rescue Ready indicator now, and make checking it part of a regular routine. Green means ready; act on anything else.
2. Confirm the device is stored within the temperature and humidity conditions above — cabinets in direct sun, sea containers and vehicles are the usual offenders.
3. If Error Code EC 501 appears, remove the device from service and contact ZOLL Medical Australia on 1800 605 555 or serviceanz@zoll.com. ZOLL manages inspection and replacement directly.
4. Record each check and its result — a documented green indicator is what shows the alert is being managed.

Reviewed 24 August 2026: AidReady was unable to re-confirm this alert on ZOLL's current product notices page, which lists nothing on the Powerheart range since 2020. That may mean the action has closed, or simply that ZOLL does not publish it there. We are checking the status with ZOLL directly, and the notice stays listed here until it is confirmed closed.

What to do next

1. Keep the AED in service and follow its voice prompts if needed.
2. Do not open pads just to inspect them.
3. If gel separation occurs during use, use spare pads if available and follow the AED instructions.

What to do next

1. Inspect the lid magnet.
2. If it is missing/dislodged, contact Stryker for the replacement lid process.
3. Until corrected, use the power button as instructed and ensure the device remains ready.

Why this ends the device, not just the pads

The CHARGE-PAK is not the operating battery — it trickle-charges a sealed internal battery, and the manufacturer requires a functional CHARGE-PAK to remain fitted at all times, including in storage. With no CHARGE-PAKs available, a stored spare cannot be kept healthy either: once your current electrodes and CHARGE-PAK expire or are used, the device cannot be returned to a rescue-ready state.

What this means for your defibrillator

The device remains safe to use while the fitted set is in date and the readiness window shows OK. In practice, the expiry date printed on that set is the date your site loses its defibrillator — record it on your maintenance schedule as the unit's out-of-service date, and plan the replacement to arrive before it. Be cautious about purchasing remaining stock: any set you find will carry its own expiry date, and it may be a short one. Stryker continues to honour warranty claims on the accessories for their 90-day warranty period.

What to do next

1. Check your current pad and CHARGE-PAK expiry dates.
2. Do not wait for the existing consumables to expire before planning replacement.
3. Plan an AED replacement so the site is not left without a supported device.

Is this one mine?

• The model number identifies the variant: 9390E and 9300E are semi-automatic and have a shock button; 9390A and 9300A are fully automatic and do not.
• Battery part numbers are not interchangeable across the family: the 9146 and 9142 fit the G3 and are non-rechargeable; the 9145 fits the G3 Pro only and is rechargeable. A standard G3 battery must never be recharged.
• G3 and G5 pads do not interchange.

What this means for your defibrillator

This is a different situation from the LIFEPAK CR Plus above, where the consumables themselves have stopped. The G3 is simply no longer made — keep it in service and keep to the normal check routine.

Some resellers have claimed that support for the G3 is ending. We have not found any manufacturer notice saying so. Treat that as a claim from an interested party and confirm current parts availability with ZOLL directly before you accept it.

What to do next

1. Keep the device in service and keep checking the Rescue Ready indicator as normal.
2. Confirm current Australian availability and pricing for your pads and battery with ZOLL on 1800 605 555 before you need them, not after.
3. Check and record the part numbers on the pads and battery fitted — the interchange traps in this family are easy to get wrong.
4. Set a replacement horizon so the decision becomes a budget item rather than an emergency.

What to do next

1. Confirm the model on the AED label.
2. Check whether it is still within its manufacturer warranty.
3. If it is outside warranty, plan replacement rather than relying on continued manufacturer support.

What to do next

1. If you have an FR2/FR2+, treat it as a legacy device.
2. Confirm current battery and pad availability before relying on it for ongoing service.
3. Plan replacement with a currently supported AED.