FDA-Device2026-10-22Class IIPACKAGING DEFECT
Solstice Xact mole marker for mammography recalled for detaching radiopaque material
What this means
The radiopaque (X-ray visible) material on the Xact mole marker can detach during use. When this happens, the loose material may create artifacts (unwanted marks or shadows) on mammography images, potentially affecting image quality and interpretation.
- If you use or have used the Xact mole marker (model M15RM, lot M15RM26A), contact Solstice Corporation or your healthcare provider.
- Do not use affected markers for new procedures.
- Inform your radiologist or imaging facility if you believe you have received care with an affected marker.
The agency's original wording
Hazard
The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
736
Manufactured in
85 E St, South Portland, Maine, United States
Products
Xact mole marker for mammography
Model/Catalog Number: M15RM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0268-2027Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.