{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "178113",
      "product_res_number": "Z-0733-2020",
      "event_date_initiated": "2019-11-13",
      "event_date_created": "2019-12-23",
      "recall_status": "Open, Classified",
      "res_event_number": "84332",
      "product_code": "LOB",
      "pma_numbers": [
        "P820075"
      ],
      "product_description": "Lamicel 20PK 3MM INTL Cervical dilator",
      "code_info": "UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438",
      "firm_fei_number": "1045254",
      "recalling_firm": "Medtronic Xomed, Inc.",
      "address_1": "6743 Southpoint Dr N",
      "city": "Jacksonville",
      "state": "FL",
      "postal_code": "32216-6218",
      "additional_info_contact": "Mike Tomberlin\n904-281-2769",
      "reason_for_recall": "Routine sterilization dose does not meet the required Sterility Assurance Level.",
      "root_cause_description": "Process control",
      "action": "Medtronic will send the Consignee Notification and Customer Confirmation Form (or equivalent record) to each listed consignee. Consignees will be asked to confirm receipt of FCA notification.",
      "product_quantity": "29320 units",
      "distribution_pattern": "Affected product was only distributed in Japan.",
      "openfda": {
        "pma_number": [
          "P840045",
          "P820075"
        ],
        "device_name": "Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}