{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Marlborough",
      "address_1": "250 Campus Dr",
      "reason_for_recall": "Tip Breakage at the glue joint between the obturator body and tip",
      "address_2": "",
      "product_quantity": "535 units",
      "code_info": "Lot Codes:  512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.",
      "center_classification_date": "20160908",
      "distribution_pattern": "US Nationwide Distribution",
      "state": "MA",
      "product_description": "SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.  ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece    Product Usage:  The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator",
      "report_date": "20160914",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Hologic, Inc",
      "recall_number": "Z-2766-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74839",
      "termination_date": "20170330",
      "more_code_info": "",
      "recall_initiation_date": "20160802",
      "postal_code": "01752-3020",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}