Xact mole marker for mammography Model/Catalog Number: M15RM recall (Solstice Corporation)
Medical deviceClass IIOngoing
Summary: Solstice Corporation is recalling Xact mole marker for mammography Model/Catalog Number: M15RM. Reason: The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
What is being recalled
Xact mole marker for mammography Model/Catalog Number: M15RM
Why
The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
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 - US Nationwide distribution in the states and territory of CA, FL, IL, IN, MN, MO, NY, OH, PA, TX, WV and Puerto Rico. The country of Canada. (states named: California, Florida, Illinois, Indiana, Minnesota, Missouri, New York, Ohio, Pennsylvania, Puerto Rico, Texas, West Virginia)
How to tell if yours is affected
part #: M15RM; UDI-DI: 00854623006068; UPC-A; lot #: M15RM26A;
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-0268-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 22, 2026 |
| Reported | October 28, 2026 |
| Company | Solstice Corporation |
| Company location | South Portland, ME, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 736 |
More recalls from Solstice Corporation · all medical device recalls · recalls from September 2026