FDA recall, , Moderate risk
HydroMARK Breast Biopsy Site Marker
The HydroMARK Breast Biopsy Site Marker has incorrect inner package labeling.
Summary by Recall Canary from the FDA notice
What happened
Devicor Medical Products Inc, of Cincinnati, Ohio, recalled the HydroMARK Breast Biopsy Site Marker, Model Number 4010-02-15-T3, because boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. The recall began April 24, 2026, and the FDA added it to its Enforcement Report on May 27, 2026. The product was distributed nationwide and in Canada and Singapore.
The recall involved 1910 units of the marker.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
HydroMARK Breast Biopsy Site Marker
- Model
- 4010-02-15-T3
- Lot code
- F12607207D
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
- Company
- Devicor Medical Products IncCincinnati, Ohio
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98843
- Recall number
- Z-2239-2026
- Quantity recalled
- 1910 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
