{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Rancho Santa Margarita",
      "address_1": "22872 Avenida Empresa # 3",
      "reason_for_recall": "Applied Medical is conducting a voluntary recall of the Inzii¿ 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of caution for patient safety and a commitmen",
      "address_2": "",
      "product_quantity": "29,506 units",
      "code_info": "Model Number CD004.  Lot Nubmers: 1161268, 1161269, 1164934, 1168358, 1168361, 1169317, 1169318, 1170694, 1170700, 1170701, 1171214, 1172482, 1172664, 1174287, 1174793, 1174857, 1175123, 1175280, 1175472, 1176555, 1177023, 1177871, 1179069, 1179392, 1179460, 1179775, 1179890, 1180291, 1180411, 1180576, 1181647, 1181648, 1181649, 1181939, 1182760, 1182934, 1183225, 1183823, 1183957, 1184273, 1184728, 1184915, 1184916, 1187779, 1188817, 1189117, 1189957, 1190294, 1190358, 1191208, 1192057, 1192969, 1193196, 1193661, 1194010, 1194666, 1194807, 1195518, 1195727, 1195997, 1197182, 1197404, 1197832, 1198055, 1198968, 1199899, 1200658, 1200828, 1200829, 1200830, 1201739, 1201740, 1201741, 1203154, 1204054.",
      "center_classification_date": "20131108",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of:  Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, New Zealand, Netherlands, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, United Arab Emirates, and United Kingdom.",
      "state": "CA",
      "product_description": "Applied Medical's Inzii¿ 12/15mm Retrieval System.    Applied\u0019s Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applied\u0019s CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.",
      "report_date": "20131120",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Applied Medical Resources Corp",
      "recall_number": "Z-0183-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66610",
      "termination_date": "20140915",
      "more_code_info": "",
      "recall_initiation_date": "20131021",
      "postal_code": "92688-2650",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}