Solstice Corporation: System, X-ray, Film Marking, Radiographic
- Recalling firm
- Solstice Corporation
- Product
- Xact mole marker for mammography Model/Catalog Number: M15RM
- Reason
- The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-22
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ccc64f41-61b0-4f23-9be0-98abcce07aaf