Device recall
Xact mole marker for mammography Model/Catalog Number: M15RM
- Recall number
- Z-0268-2027
- Event id
- 99956
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Solstice Corporation
- Report date
- Oct 28, 2026
- Posted
- Oct 22, 2026
- Initiated
- Sep 22, 2026
- Center classification date
- Oct 22, 2026
- Product code
- JAC
- Device type
- System, X-Ray, Film Marking, Radiographic
- Reason
- The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
- Root cause
- Process control
- Quantity
- 736
- Code info
- part #: M15RM; UDI-DI: 00854623006068; UPC-A; lot #: M15RM26A;
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- South Portland, ME, United States