Recall Z-0268-2027 ยท JAC System, X-Ray, Film Marking, Radiographic
Solstice Corporation
Xact mole marker for mammography Model/Catalog Number: M15RM
| Date | Oct 22, 2026 (initiated Sep 22, 2026) |
| Status | Open, Classified |
| Reason | The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material. |
| Root cause | Process control |
| Action | September 22, 2026, URGENT: Medical Device Removal letters were sent to customers. Action to be Taken: Please discontinue use of lot M15RM26A immediately and place any remaining inventory in quarantine. Product should be returned to the address below for free replacement or refund using Solstice UPS Account #A5255W. If you do not have UPS access, please email info@solsticecorp.com and request a prepaid label. Solstice Corporation Solstice Corporation has identified the cause of this defect and corrective action has been taken to ensure it will not recur. Any adverse events or other problems s |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.