FDA Medical Device · Z-0268-2027

Xact mole marker for mammography Model/Catalog Number: M15RM

Class II · Ongoing

The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.

Affected lots / codes — check yours against thispart #: M15RM; UDI-DI: 00854623006068; UPC-A; lot #: M15RM26A;

Recalling firm: Solstice Corporation, South Portland, ME
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
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: September 22, 2026
Classified: October 22, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0268-2027%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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