Solstice Corporation recalls Xact mole marker for mammography
- Recalling company
- Solstice Corporation
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 22, 2026
- Reported
- Oct 28, 2026
- 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.
- Status
- Ongoing
- Quantity
- 736
- Lot / codes
- part #: M15RM; UDI-DI: 00854623006068; UPC-A; lot #: M15RM26A;
- Company location
- South Portland, ME
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0268-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0268-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.