HydroMARK™ Breast Biopsy Site Marker Recall
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
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 1, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, MedicalDevice.
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 ↗
Related Product & Food Recalls
All Product & Food Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,355 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 1, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.