{
  "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,
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  "results": [
    {
      "cfres_id": "94521",
      "product_res_number": "Z-0073-2011",
      "event_date_initiated": "2010-09-17",
      "event_date_posted": "2010-10-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-10-19",
      "res_event_number": "56789",
      "product_code": "EZQ",
      "product_description": "ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier;\n1 1/4 in., 32mm;\nMade in Dominican Republic;\nConvaTec.\nColostomy pouch",
      "code_info": "Product order number: 125333, Lot number: 0G01881",
      "firm_fei_number": "3011987967",
      "recalling_firm": "Convatec Inc.",
      "address_1": "200 Headquarters Park Drive",
      "city": "Skillman",
      "state": "NJ",
      "postal_code": "08558-2600",
      "additional_info_contact": "Karen Karenta\n800-422-8811",
      "reason_for_recall": "Mislabeled: the market units were incorrectly labeled as # 125339 ActiveLife Drainable Pouch 25 mm; the product inside was actually ActiveLife Pouch Small Tan 32 mm, ICC # 125333.",
      "root_cause_description": "Labeling mix-ups",
      "action": "ConvaTec, Inc. sent a Returned Goods Authorization form by e-mail dated September 3, 2010, to one customer.  The form identified the product, the problem, and the action the customer should take. The customer was instructed to detach the label and affix it to the outside of the box, copy the RGA # and retain a copy for their records, enclose the completed form and return with the product,  \nFor questions call (908) 904-2675.",
      "product_quantity": "1 case (20 market units)",
      "distribution_pattern": "USA, including IL",
      "openfda": {
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          "K111365",
          "K083785",
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          "K102536",
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        "device_name": "Pouch, Colostomy",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5900",
        "device_class": "1",
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