HydroMARK Breast Biopsy Marker Recall: Incorrect Labeling Risk
Devicor Medical Products recalls HydroMARK Breast Biopsy Site Marker Model 4010-02-15-T3 due to incorrect inner package labeling. Boxes labeled 401:02:15-T3 may contain T4 markers instead.
Lower-risk recall
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Contact the company
What happened, in plain English
Devicor Medical Products is recalling HydroMARK Breast Biopsy Site Markers with model number 4010-02-15-T3 because the inner packaging labels are incorrect. This could lead to using the wrong type of marker during medical procedures, which might cause errors in treatment. Read more at govinfonow.com/recall/49385-hydromark-breast-biopsy-marker-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/49385-hydromark-breast-biopsy-marker-recall-incorrect-labeling-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2239-2026
Cite this page
“HydroMARK Breast Biopsy Marker Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49385-hydromark-breast-biopsy-marker-recall-incorrect-labeling-risk. Based on FDA recall #Z-2239-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2239-2026%22&limit=1).
Why it’s dangerous
The inner packaging of the markers is labeled incorrectly. Boxes marked as 4010-02-15-T3 may contain individual packages labeled as T4 markers instead of the correct type. This could lead to using the wrong marker during medical procedures, potentially causing treatment errors.
Who’s affected
Healthcare providers who use the HydroMARK Breast Biopsy Site Marker model 4010-02-15-T3 are likely affected. Patients undergoing breast biopsies using this model may be at risk of incorrect marker usage.
How to tell if you have this one
Check for the model number 4010-02-15-T3 on the outer box. The inner packages may be labeled as T4 markers instead of the correct type.
- Brand
Devicor Medical Products- Category
Medical device
What to do — step by step
Check Package Labels
Verify the inner package labels to ensure they match the model number 4010-02-15-T3.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2239-2026 (April 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2239-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.