CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report
Xact mole marker for mammography recalled by Solstice
Solstice is recalling Xact mole marker for mammography, distributed nationwide in the US. The recall was initiated on 22 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0268-2027
- FDA event ID
- 99956
- Recalling firm
- Solstice, South Portland, ME
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Sep 2026
- FDA classified
- 22 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 22 Sep 2026 | Recall initiated by company | |
| 22 Oct 2026 | Classified by FDA | +30 days |
| 28 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
Product as listed by the FDA
Xact mole marker for mammography Model/Catalog Number: M15RM
Where it was distributed
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.
Nationwide CaliforniaFloridaIllinoisIndianaMinnesotaMissouriNew YorkOhioPennsylvaniaPuerto RicoTexasWest Virginia
Questions about this recall
Why was it recalled?
The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
Which lots are affected?
part #: M15RM; UDI-DI: 00854623006068; UPC-A; lot #: M15RM26A;
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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