{"recall":{"id":"fda-device-99956","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Solstice Corporation recalls Xact mole marker for mammography Model/Catalog Number: M15RM","firm":"Solstice Corporation","date":"2026-09-22","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"Xact mole marker for mammography Model/Catalog Number: M15RM","code":"part #: M15RM; UDI-DI: 00854623006068; UPC-A; lot #: M15RM26A;","quantity":"736","number":"Z-0268-2027","classification":"Class II"}],"reason":"The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"736","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99956","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a8af76715cbe54ca","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99956","record":[{"status":"Ongoing","city":"South Portland","state":"ME","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99956","recalling_firm":"Solstice Corporation","address_1":"85 E St","address_2":"","postal_code":"04106-2870","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-0268-2027","product_description":"Xact mole marker for mammography  Model/Catalog Number: M15RM","product_quantity":"736","reason_for_recall":"The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.","recall_initiation_date":"20260922","center_classification_date":"20261022","report_date":"20261028","code_info":"part #: M15RM; UDI-DI: 00854623006068;  UPC-A; lot #: M15RM26A;","more_code_info":""}]}}