Reported Oct 28, 2026 · Ongoing · Updated Nov 2, 2026
Xact mole marker for mammography Model/Catalog Number: M15RM
Solstice Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Solstice Corporation · 85 E St · South Portland, ME · 04106-2870
Is this the product you have?
- Xact mole marker
- for mammography Model/Catalog NumberM15RM
- Lot codes and dates
- part #: M15RM
- UDI-DI
00854623006068UPC-Alot #: M15RM26A
- Amount recalled
- 736
Where it was sold
Why it was recalled
The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Solstice Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.