{
  "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": [
    {
      "status": "Terminated",
      "city": "Skillman",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68292",
      "recalling_firm": "Convatec Inc.",
      "address_1": "200 Headquarters Park Dr",
      "address_2": "N/A",
      "postal_code": "08558-2600",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide",
      "recall_number": "Z-1785-2014",
      "product_description": "Convatec Flexi Seal Control Fecal Management System Rx Only   REF 411107      Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.",
      "product_quantity": "73,021 units US; 24,866 units OUS",
      "reason_for_recall": "Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer  feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control  has not been consistently performing relative",
      "recall_initiation_date": "20140429",
      "center_classification_date": "20140613",
      "termination_date": "20150828",
      "report_date": "20140625",
      "code_info": "13-FM-0301   13-FM-0302   13FM0303   13-FM-0303   13FM0309   13VM509948   13VM509949   13VM510046   13VM512473   13VM513636   13VM513642   13VM516733   13VM520039   13VM521731   13VM521733   13VM524363   13VM524364   13VM527149   13VM527150   13VM528992   13VM528994   13VM531214   14FM0301   14VM531935   14VM532098",
      "more_code_info": ""
    }
  ]
}