HydroMARK Breast Biopsy Site Marker recall (Devicor Medical Products Inc)
Medical deviceClass IIOngoing
Summary: Devicor Medical Products Inc is recalling HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3. Reason: Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
What is being recalled
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Why
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
How to tell if yours is affected
Lot Number: F12607207D
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2239-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 24, 2026 |
| Reported | June 3, 2026 |
| Company | Devicor Medical Products Inc |
| Company location | Cincinnati, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1910 units |
More recalls from Devicor Medical Products Inc · all medical device recalls · recalls from April 2026