HydroMARK™ Breast Biopsy Site Marker Recall

Source: Health Canada · Canada

Devicor Medical Products, Inc. is recalling certain HydroMARK™ Breast Biopsy Site Markers due to incorrect inner package labeling, where boxes labeled as 4010-02-15-T3 may contain T4 markers.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on May 6, 2026 and geographically references Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Product & Food Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized Health Canada recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, health-canada, MedicalDevice) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Devicor Medical Products, Inc. is conducting a voluntary medical device recall for certain HydroMARK™ Breast Biopsy Site Markers because of incorrect inner package labeling. Specifically, boxes labeled as 4010-02-15-T3 may contain individual packages labeled as T4 Markers.

Which Products Are Affected

The affected product is the HydroMARK™ Breast Biopsy Site Marker with lot number F12607207D and model or catalogue number 4010-02-15-T3. Users should identify and remove from use any devices labeled as 4010-02-15-T4 from this lot. No quantities, UPCs, or specific regions were detailed in the recall notice.

What You Should Do

Users should immediately remove from use any devices labeled as 4010-02-15-T4 from lot F12607207D. No additional contact information for returns or refunds was provided in the source.

Why This Matters

This recall addresses potential risks from using the wrong medical device, which could affect the accuracy of breast biopsy procedures and patient safety. It highlights the importance of proper labeling in medical products to prevent errors.

Source

This information is from Health Canada. For more details, visit: https://recalls-rappels.canada.ca/en/alert-recall/hydromarktm-breast-biopsy-site-marker

Original source: Health Canada Official Notice ↗

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Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Devicor Medical Products, Inc. is recalling certain HydroMARK™ Breast Biopsy Site Markers due to incorrect inner package labeling, where boxes labeled as 4010-02-15-T3 may contain T4 markers.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.