Z-0268-2027

Xact mole marker for mammography Model/Catalog Number: M15RM

Name: Z-0268-2027 Xact mole marker for mammography Model/Catalog Number: M15RM
Creator: Solstice Corporation
Published: 2026-09-22
License: https://open.fda.gov/license/

Solstice Corporation / initiated 2026-09-22 / Open, Classified

FDA source

Recall record

Recall number: Z-0268-2027
Status: Open, Classified
Initiated: 2026-09-22
Posted: 2026-10-22
Recalling firm: Solstice Corporation
Product: Xact mole marker for mammography Model/Catalog Number: M15RM
Product code: JAC System, X-Ray, Film Marking, Radiographic
Reason for recall: The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
FDA 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 [email protected] 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.
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.
Product codes and lots: part #: M15RM; UDI-DI: 00854623006068; UPC-A; lot #: M15RM26A;

Product code JAC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-21, the FDA export date for this dataset. Page last changed 2026-10-30. View this recall on fda.gov (opens on fda.gov)