{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Santa Clarita",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80099",
      "recalling_firm": "TriMed Inc.",
      "address_1": "27533 Avenue Hopkins",
      "address_2": "N/A",
      "postal_code": "91355-3910",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL;  OUS: Australia and Sweden",
      "recall_number": "Z-2263-2018",
      "product_description": "Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22",
      "product_quantity": "323",
      "reason_for_recall": "During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly  dose audits/verification required to comply with the regulations could not be found. Sterilization  records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.",
      "recall_initiation_date": "20180413",
      "center_classification_date": "20180620",
      "termination_date": "20210122",
      "report_date": "20180627",
      "code_info": "Lot #: a) R900,  009J,  050511,  00AG,  0095,  183601,  10505-11,  193601;  b) R903,  26404,  264-04,  03NK,  050512,  10505-12,  24604,  11811,  181102,  181103,  188803;  c) 26405,  009N,  00AL,  R904,  00A1,  00PN,  050513,  10505-13,  183501,  83501,  264-05,  004L,"
    }
  ]
}