PV Bulletin

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.

Action needed

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

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
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.

Related updates for your role

publicFDA · USA · Updated Sep 4, 2026

FDA Grants Accelerated Approval to Etcamah for Advanced Breast Cancer

Urgency: High

Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 4, 2026

Change to the definition of regulated activity with children from 1 September 2026

Urgency: High

Organizations must re-evaluate roles related to children's activities and prepare to request Enhanced DBS checks including access to the Children’s Barred List check starting from 1 September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Sep 7, 2026

Low Flu Vaccination Rates Among Primary School Children

Urgency: High

Parents are reminded to complete and return flu vaccination consent forms promptly as vaccination sessions in schools are set to start this week, aiming for completion by late November.

Signal ManagementPV Quality Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: PV Quality Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of Gore Viabahn Endoprosthesis with Bioactive Heparin Coating

Urgency: High

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward