Health Canada Recalls Physio-Control LIFEPAK 35 Defibrillators Over Flaw

Health Canada has issued a Type II medical device recall for the Physio-Control LIFEPAK ® 35 Monitor/Defibrillator after the manufacturer discovered a build quality problem that could compromise two of the unit’s rear access ports. The recall, identified under number RA-82601, was dated August 27, 2026, and published by Health Canada on September 4, 2026.

The affected devices are used in hospitals and emergency care settings to monitor patients and deliver defibrillation when needed, making any hardware defect a matter of immediate clinical concern.

What Went Wrong?

According to the notice, Stryker, the parent company of manufacturer Physio-Control, found during production that certain printer and modem access port connectors on the LP35 may not have been fully seated within the rear housing assembly. Rather than extending beyond the retaining nut as designed, the connectors can sit flush with it or even recessed below it.

Health Canada classified this as a ‘Performance’ issue affecting medical devices, meaning the connector fault could interfere with how the printer or modem functions integrate with the rest of the device during patient care.

Products Affected by This Recall

The recall covers multiple production lots of the ‘LIFEPAK ® 35 Monitor/Defibrillator’ sold under the Physio-Control, Inc. brand. Health Canada’s notice lists more than a dozen model or catalogue numbers tied to the issue, including:

• 70335-000180
• 70335-000181
• 70335-000182
• 70335-000183
• 70335-000184
• 70335-000185
• 70335-000047
• 99335-000035
• 99335-000121
• 99335-000122
• 99335-000123
• 99335-000124
• 99335-000125
• 99335-000126

For each of these model numbers, Health Canada notes that there are ‘more than 10’ associated lot or serial numbers, and it directs facilities to contact the manufacturer directly to confirm whether a specific unit is included.

Who Should Be Concerned

This is a healthcare-audience recall rather than a general consumer alert. Hospitals, ambulance services, clinics, and any other healthcare facility that has purchased or operates a LIFEPAK 35 unit should check their equipment inventory against the listed model numbers. Physio-Control, Inc. is based in Redmond, Washington, and the affected devices were distributed to healthcare providers across Canada.

Because the LIFEPAK 35 is a frontline monitoring and defibrillation tool, any facility using one of the listed catalogue numbers should treat verification as a priority rather than a routine administrative task.

How to Respond to This Recall

Health Canada’s guidance for this recall is direct: affected facilities should contact the manufacturer if they require additional information about specific units, lot numbers, or corrective steps. The notice does not describe a broader public disposal or replacement instruction beyond this manufacturer contact, since resolution depends on confirming which individual serial numbers are implicated.

Facilities that identify a potentially affected unit should follow their internal biomedical engineering or equipment-management protocols while awaiting confirmation from Physio-Control, and should continue to follow the manufacturer’s guidance on any interim precautions for the printer and modem access ports.

From the Agency

Health Canada’s published notice describes the issue in the manufacturer’s own technical terms, stating that ‘during production of LP35, Stryker identified that certain printer and modem access port connectors may not have been fully seated within the rear housing assembly,’ and that as a result ‘the connectors may appear flush with or recessed relative to the retaining nut rather than extending beyond it as intended.’

The recall is catalogued as a Type II health product recall under the cardiovascular device category, with Health Canada listing the original publication date as September 4, 2026, and the underlying recall date as August 27, 2026. No additional public-facing remedy details, such as free repair kits or replacement units, were specified in the notice beyond directing facilities to the manufacturer.