Health Canada Recalls Stryker LIFEPAK 35 Defibrillator Over Display Issue 2026

Health Canada has issued a Type II recall notice for Stryker’s LIFEPAK 35 Monitor/Defibrillator after the manufacturer identified a software display fault that can affect how the device alerts clinicians during patient monitoring. The recall, identified under number RA-82590, was dated 2026-08-27 and published by Health Canada on 2026-09-02, targeting hospitals and healthcare facilities across the country that use the device.

According to the notice, Stryker’s subsidiary Physio-Control, Inc. found that under specific conditions occurring simultaneously, the LIFEPAK 35 does not display the message ‘CHECK RHYTHM / ECG Analysis Inconclusive’ as intended. This on-screen prompt is meant to tell clinical staff that the device could not confidently interpret a patient’s cardiac rhythm and that manual review is required.

Products Affected by This Recall

The recall covers multiple catalogue numbers of the LIFEPAK 35 Monitor/Defibrillator sold under the Physio-Control, Inc. brand. Affected model or catalogue numbers include 70335-000180, 99335-000123, 99335-000124, 70335-000182, 70335-000185, 99335-000126, 70335-000184, 99335-000121, 70335-000183, 99335-000035, 99335-000125, 70335-000047, 70335-000181, and 99335-000122. Health Canada notes that more than ten serial or lot numbers are associated with the issue, and facilities are advised to contact the manufacturer directly to confirm whether their specific unit is included.

What Went Wrong?

The nonconformance is limited to the on-screen alert function of the device rather than its core diagnostic or therapeutic capability. Health Canada’s notice states that the issue does not affect the display of ‘shock advised’ or ‘no shock advised’ messages, meaning therapy delivery guidance remains functional. Rhythm analysis itself is also not impacted; the problem is confined strictly to whether the secondary ‘CHECK RHYTHM’ prompt appears on screen when it should.

Even so, in a device built for use during cardiac emergencies, any inconsistency in on-screen prompts carries real weight. Clinicians rely on these alerts as part of a broader decision-making process, and a missing inconclusive-analysis warning could, in rare and specific circumstances, mean a caregiver receives less complete information than intended, even though the core shock recommendation is unaffected.

Who Should Be Concerned

This recall is directed at a healthcare audience rather than the general public. Hospitals, emergency medical services, and other clinical environments that operate the LIFEPAK 35 for cardiac monitoring and defibrillation are the primary parties affected. Health Canada’s listing classifies the alert’s audience strictly as ‘Healthcare,’ and the affected products are distributed by Physio-Control, Inc., based in Redmond, Washington.

Because the device is used in high-acuity settings such as intensive care units, ambulances, and emergency departments, biomedical engineering teams and clinical staff responsible for defibrillator inventories should treat this notice as a priority item to review against their equipment logs.

What Consumers Need to Do Now

• Healthcare facilities should check their LIFEPAK 35 units against the listed catalogue numbers.
• Contact Physio-Control, Inc. directly to confirm whether a specific device’s serial number is part of the affected population, since Health Canada notes more than ten numbers are involved and advises reaching the manufacturer for the full list.
• Continue using the device as normal for shock delivery, since ‘shock advised’ and ‘no shock advised’ displays are unaffected, while remaining aware that the ‘CHECK RHYTHM’ inconclusive-analysis message may not always appear as expected.
• Report any related concerns to Health Canada through its health and safety concern reporting channel.

Regulatory Response

Health Canada has published the notice as a Type II medical device recall under its Cardiovascular category, with Physio-Control, Inc. listed as the responsible company. Per the official summary, the recommended action for affected facilities is straightforward: ‘Contact the manufacturer if you require additional information.’ The notice was last updated on 2026-09-02 and remains listed on Health Canada’s recalls and safety alerts database for ongoing reference by healthcare providers.

No injuries or adverse events tied to the display fault were detailed in the published notice. Health Canada encourages anyone with additional information or concerns about the device’s performance to report it through the department’s official channels.