{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "222972",
      "product_res_number": "Z-0268-2027",
      "event_date_initiated": "2026-09-22",
      "event_date_posted": "2026-10-22",
      "recall_status": "Open, Classified",
      "res_event_number": "99956",
      "product_code": "JAC",
      "product_description": "Xact mole marker for mammography\nModel/Catalog Number: M15RM",
      "code_info": "part #: M15RM;\nUDI-DI: 00854623006068; \nUPC-A;\nlot #: M15RM26A;",
      "firm_fei_number": "1221946",
      "recalling_firm": "Solstice Corporation",
      "address_1": "85 E St",
      "city": "South Portland",
      "state": "ME",
      "postal_code": "04106-2870",
      "additional_info_contact": "Danforth DeSena\n1-800-8747922",
      "reason_for_recall": "The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.",
      "root_cause_description": "Process control",
      "action": "September 22, 2026, URGENT: Medical Device Removal letters were sent to customers.\nAction to be Taken:\nPlease 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.\nSolstice Corporation\n\nSolstice 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.",
      "product_quantity": "736",
      "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.",
      "openfda": {
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          "K925332",
          "K930752"
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          "3008632256",
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        ],
        "device_name": "System, X-Ray, Film Marking, Radiographic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1640",
        "device_class": "1"
      }
    }
  ]
}