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RegulatorsHealth CanadaCanada

Omnipod Insulin Management System Recall in Canada

Health Canada posted a recall for Omnipod Insulin Management System due to product performance issues.

PV Impact Brief

Urgency: HighConfidence: high
Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Action needed

Identify affected lots and implement recall procedures as per Health Canada guidelines.

Owner

Regulatory Intelligence Lead

Review cadence

action required within 24 hours

Regulatory action details

Action type
Health product recall
Publication date
2026-06-01
Safety issue
Recall for Omnipod Insulin Management System due to product performance issues.

Affected products

  • Omnipod Insulin Management System
    Insulet Corporation

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 1, 2026

Full briefing

What changed

Health Canada announced a recall for Omnipod Insulin Management System due to product performance issues.

Why it matters

Product performance issues may lead to insulin delivery errors, posing serious health risks to users.

Practical implication

Identify affected lots and implement recall procedures as per Health Canada guidelines.

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Omnipod Insulin Management System Recall in Canada | PV Bulletin