{
  "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": "Garland",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80021",
      "recalling_firm": "Galt Medical Corporation",
      "address_1": "2220 Merritt Dr",
      "address_2": "N/A",
      "postal_code": "75041-6137",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY,  NC, and Puerto Rico;    OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea",
      "recall_number": "Z-2559-2018",
      "product_description": "1) Vascular Dilator,  Sterile EO, Rx Only, Catalog #: DIL-100-12;    2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11;    3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14;    4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14;    5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04;    6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11;    7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12;    8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02;    9) \"Micro-Access\" Kit, Sterile EO, Catolog #: KIT-900-88    10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;",
      "product_quantity": "9050",
      "reason_for_recall": "The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.",
      "recall_initiation_date": "20180502",
      "center_classification_date": "20180727",
      "termination_date": "20200720",
      "report_date": "20180808",
      "code_info": "lot #: 1) 18102478;    2) 18033450;    3) a) 18089973; b) 18031311; c) 18046318; d) 18082001; e) 18040777, 18061334;    4) S17342075;    5) P18015009;    6) S18051159, S18072306;    7) S18072307;    8)  a) S18033049,  S18064105, S18093202, S18096316; b) S18025037, S18032055, S18032100, S18032101, S18093199, S18096314; c) S18093200; d) S18032056, S18032102, S18052063, S18074161, S18093203, S18096318; e) S18064104, S18093201; f) S18096315;    9) S18018008;    10) a) G18012001, G18064125; b) S18017001"
    }
  ]
}