PV Bulletin
Health CanadaCanada

Dexcom G7 Sensor Lot Recall – Unauthorized Distribution of Non-Conforming Lots in Canada

Two lots of Dexcom G7 Sensor (1-Pack) distributed in Canada by an unauthorized third party despite being intended for destruction due to non-conformance.

Primary source: Health Canada

PV Impact Brief

Urgency: HighConfidence: high

What changed

Health Canada published a recall alert for two unauthorized lots of Dexcom G7 Sensor distributed in Canada.

Why it matters

Patients using sensors from these lots may experience inaccurate glucose readings, leading to potential harm from incorrect insulin dosing.

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Action needed

Identify and quarantine products from lots 1725204004 and 1725069002; contact patients who received sensors from these lots; report adverse events if any.

Owner

Regulatory Intelligence Lead

Review cadence

as needed

Regulatory action details

Action type
Medical Device Recall
Publication date
2026-06-03
Safety issue
Recall due to unauthorized device issues or quality defects identified in Canada.

Affected products

  • Dexcom G7 Sensor 1 Pack
    Dexcom, Inc.

PV internal implications

Stop using the device if advised and contact the manufacturer for replacement or further guidance.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 3, 2026

Full briefing

Practical implication

Identify and quarantine products from lots 1725204004 and 1725069002; contact patients who received sensors from these lots; report adverse events if any.

Health Canada issued an alert for two lots of Dexcom G7 Sensor (lot #1725204004 and lot #1725069002) that were diverted from destruction and sold through unauthorized channels. The sensors did not meet Dexcom's product standards and may pose a safety risk.

What changed: Health Canada published a recall alert for two unauthorized lots of Dexcom G7 Sensor distributed in Canada.

Why it matters: Patients using sensors from these lots may experience inaccurate glucose readings, leading to potential harm from incorrect insulin dosing.

Practical implication: Identify and quarantine products from lots 1725204004 and 1725069002; contact patients who received sensors from these lots; report adverse events if any.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals#Health Product Recall#Health Canada#safety_signal#firecrawl-agent#regulatory-extraction

Related updates for your role

publicEuropean Medicines Agency · EU · Updated Jul 15, 2026

Reflection paper on particulars for safety signals for (traditional) herbal medicinal products

Urgency: High

Implement increased documentation and reporting processes for traditional herbal medicinal products. Ensure staff receive training on the complexities involved in signal management for these products.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Draft Guidance
Read impact briefarrow_forward
publicSwissmedic · Switzerland · Updated Jul 17, 2026

Checklist for the Inspection of Medical Device Vigilance in Hospitals

Urgency: High

Healthcare facilities must utilize the new checklist during inspections to conduct gap analyses and ensure compliance with reporting requirements associated with their vigilance systems.

Inspection ReadinessRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Checklist
Read impact briefarrow_forward
publicEuropean Medicines Agency · EU · Updated Jul 15, 2026

Updated eCTD v4.0 technical validation criteria

Urgency: High

All electronic PV submissions must undergo new validation checks in accordance with the updated criteria to ensure compliance and accuracy.

Country ComplianceICSRRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Technical Guidance
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jul 15, 2026

Order Providing for Reliance on Foreign Regulatory Authority Decisions for Certain Drugs (Ministerial Reliance Order)

Urgency: High

Manufacturers must demonstrate that any variances from the foreign authorized drugs do not adversely affect safety or effectiveness when filing for deeming under this new framework.

Country ComplianceSignal ManagementRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV
verifiedRegulatory action: Draft Guidance
Read impact briefarrow_forward