{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "167197",
      "product_res_number": "Z-0090-2019",
      "event_date_initiated": "2018-09-17",
      "event_date_posted": "2018-10-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-08-04",
      "res_event_number": "80999",
      "product_code": "PNH",
      "k_numbers": [
        "K152090"
      ],
      "product_description": "Reprocessed Agilis Steerable Introducer:  indicated for introducing various cardiovascular catheters into the heart.  \n(a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309;  \n(b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310;  \n(c) large curl (50 mm curve type/71 cm length), Product Code STJ408324",
      "code_info": "All lots with expiration dates prior to 2019-06-08 of the following: (a)\tProduct Code STJ408309, GTIN 10888551044912  (b)\tProduct Code STJ408310, GTIN 10888551044929 (c)\tProduct Code STJ408324, GTIN 10888551044950",
      "firm_fei_number": "3011276773",
      "recalling_firm": "Sterilmed, Inc.",
      "address_1": "5010 Cheshire Pkwy N Ste 2 5010 Cheshire Pkwy N",
      "address_2": "Ste 2",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55446-4101",
      "reason_for_recall": "Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.",
      "root_cause_description": "Material/Component Contamination",
      "action": "Sterilmed notified customers on about 09/17/2018, via URGENT MEDICAL DEVICE RECALL letter sent via UPS next day.  Instructions included examine inventory for affected devices, remove and return affected devices to Stericycle (3rd party processor), provide recall information to appropriate personnel at the facility, and complete and return the Business Reply Form to Stericycle.  For questions, contact Sterilmed's Customer Care Team at (888) 541-0078, Monday through Friday from 7:00 AM to 5:00 PM CST.",
      "product_quantity": "218 units",
      "distribution_pattern": "U.S. Nationwide distribution in the states of  CA, CO, MN, and WA.",
      "openfda": {}
    }
  ]
}