| | Class 2 Device Recall Xact |  |
| Date Initiated by Firm | September 22, 2026 |
|---|
| Date Posted | October 22, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0268-2027 |
|---|
| Recall Event ID |
99956 |
| Product Classification |
System, x-ray, film marking, radiographic - Product Code JAC
|
| Product | Xact mole marker for mammography
Model/Catalog Number: M15RM |
|---|
| Code Information |
part #: M15RM;
UDI-DI: 00854623006068;
UPC-A;
lot #: M15RM26A; |
| FEI Number |
1221946
|
Recalling Firm/
Manufacturer |
Solstice Corporation
85 E St
South Portland
ME
04106-2870
|
| For Additional Information Contact | Danforth DeSena
1-800-8747922 |
|---|
Manufacturer Reason
for Recall | The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material. |
|---|
FDA Determined
Cause 2 | 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 should be reported to www.FDA.gov/MedWatch. This product is now backordered with availability expected around October 15, 2026. |
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| Quantity in Commerce | 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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