FDA recall, , Moderate risk
Solstice Xact Mole Marker for Mammography
The Xact mole marker for mammography may have its radiopaque material detach, causing artifacts.
Summary by Recall Canary from the FDA notice
What happened
Solstice Corporation began a recall on September 22, 2026, of the Xact mole marker for mammography because the radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material. The recall was added to the FDA's Enforcement Report and classified on October 22, 2026. Distribution was worldwide, including US nationwide distribution in CA, FL, IL, IN, MN, MO, NY, OH, PA, TX, WV and Puerto Rico, and the country of Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Xact mole marker for mammography
- Model number
- M15RM
- UDI-DI
- 00854623006068
- Lot code
- M15RM26A
Recall details
- Company began the recall
- Sold in
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.
- Company
- Solstice Corporation
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99956
- Recall number
- Z-0268-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
