TemporaryFDAOngoing
Can cause harm that is usually temporary.
Xact mole marker for mammography Model/Catalog Number: M15RM
Check the device or its packaging for
part #: M15RM; UDI-DI: 00854623006068; UPC-A; lot #: M15RM26A;
- Why
- The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
- Distributed
- 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.
- Company
- Solstice Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0268-2027 · retrieved 22 October 2026
Read the official notice