# Class II recall Z-0268-2027: Solstice Corporation

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0268-2027 |
| Recalling firm | Solstice Corporation |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| Quantity | 736 |
| 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. |
| Recall initiated | 2026-09-22 |
| Reported | 2026-10-28 |
| Firm location | South Portland, ME, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0268-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.