{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "160416",
      "product_res_number": "Z-0351-2018",
      "event_date_initiated": "2017-07-07",
      "event_date_created": "2018-01-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-04-04",
      "res_event_number": "78777",
      "product_code": "OIJ",
      "k_numbers": [
        "K161575"
      ],
      "product_description": "Affirm Lateral Arm Upright Biopsy Accessory. Product Number:\tASY-09880",
      "code_info": "UDI Number:\t\t15420045506817 Serial Numbers: \tLAT1200100   LAT1200165",
      "firm_fei_number": "1220984",
      "recalling_firm": "Hologic, Inc.",
      "address_1": "36 and 37 Apple Ridge Rd",
      "city": "Danbury",
      "state": "CT",
      "postal_code": "06810-7301",
      "additional_info_contact": "203-207-4500",
      "reason_for_recall": "The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.",
      "root_cause_description": "Component change control",
      "action": "Letter",
      "product_quantity": "12 (U.S.)",
      "distribution_pattern": "US and OUS",
      "openfda": {
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        "device_name": "Biopsy Needle Guide Kit",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1560",
        "device_class": "2"
      }
    }
  ]
}