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Class IIOngoing

Solstice Corporation recalls Xact mole marker for mammography Model/Catalog Number: M15RM

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Solstice Corporation
Reason
The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99956…

Products

  1. Xact mole marker for mammography Model/Catalog Number: M15RM

    Codes/lots: part #: M15RM; UDI-DI: 00854623006068; UPC-A; lot #: M15RM26A;Quantity: 736Recall no. Z-0268-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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