Recall Z-0268-2027— Solstice Corporation
Class II · Ongoing
Class II FDA medical device recall by Solstice Corporation, initiated 2026-09-22. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Solstice Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-22
- Firm location
- South Portland, ME, United States
Product description
Xact mole marker for mammography Model/Catalog Number: M15RM
Reason for recall
The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
Data sourced from openFDA. This site is unofficial and independent of the FDA.