{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Plymouth",
      "address_1": "5010 Cheshire Pkwy N Ste 2",
      "reason_for_recall": "Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.",
      "address_2": "",
      "product_quantity": "218 units",
      "code_info": "All lots with expiration dates prior to 2019-06-08 of the following:  (a) Product Code STJ408309, GTIN 10888551044912   (b) Product Code STJ408310, GTIN 10888551044929  (c) Product Code STJ408324, GTIN 10888551044950",
      "center_classification_date": "20181009",
      "distribution_pattern": "U.S. Nationwide distribution in the states of  CA, CO, MN, and WA.",
      "state": "MN",
      "product_description": "Reprocessed Agilis Steerable Introducer:  indicated for introducing various cardiovascular catheters into the heart.    (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309;    (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310;    (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324",
      "report_date": "20181017",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Sterilmed, Inc.",
      "recall_number": "Z-0090-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80999",
      "termination_date": "20200804",
      "more_code_info": "",
      "recall_initiation_date": "20180917",
      "postal_code": "55446-4101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}