{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "218805",
      "product_res_number": "Z-1582-2026",
      "event_date_initiated": "2026-02-16",
      "event_date_posted": "2026-03-19",
      "recall_status": "Open, Classified",
      "res_event_number": "98455",
      "product_code": "FON",
      "product_description": "Convatec, EsteemBody Drainable Pouch\nREF:423643, \n10-45mm",
      "code_info": "UDI: 00768455221264 Lot: 5K00011,5K00714",
      "firm_fei_number": "3011987967",
      "recalling_firm": "ConvaTec, Inc",
      "address_1": "7815 National Service Rd Ste 600 7815 National Service Rd",
      "address_2": "Ste 600",
      "city": "Greensboro",
      "state": "NC",
      "postal_code": "27409-9403",
      "additional_info_contact": "336-547-3730",
      "reason_for_recall": "Drainable large pouch may leak due to manufacturing issue.",
      "root_cause_description": "Process control",
      "action": "On February XX, 2026 Convatec issued a updated Urgent Medical Device Recall Notification via E-Mail. The initial notification was issued February 16, 2026. Convatec asked consignees to take the following actions:\n\n1. Review your personal supplies and determine if you are affected by this communication.\n\n2. Discontinue use and dispose of the affected product.\n\n3. Complete Response Form  and return to Convatec within 30 days.\n\n4. Acknowledgment of this action is critical. If you re not able to provide a written response liaise with your distributor or Convatec Customer Services can support.\n\n 5. Customer care team is available to assist you with any questions and provide product alternatives if needed. Please contact the regional Convatec Customer Services us.customerservice@convatec.com\n\nDistributor:\n\n1. Notify all downstream customers who may have received affected product. This letter may be used to support transmission of the communication.\n\n2. For additional instructions reference customer notification",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.",
      "openfda": {
        "k_number": [
          "K801504",
          "K770826",
          "K772366"
        ],
        "registration_number": [
          "3023339256",
          "3031184338",
          "3011814545",
          "3010621964",
          "3011495142",
          "3011987967",
          "3006554788",
          "3031590640",
          "3010198795",
          "3007417132",
          "3010370474",
          "3014351477",
          "9710391",
          "3015142802",
          "3010827261",
          "3006517436",
          "3012034017",
          "3019865496",
          "3007028040",
          "3038624153",
          "3011529314",
          "3006897996",
          "3012680643",
          "3016758972",
          "3010160370",
          "3003814961",
          "2433012",
          "3011191255",
          "9618003",
          "3010131137",
          "3048248080",
          "3000247987",
          "8022890",
          "3042283853",
          "3017896419",
          "3030226295",
          "9610694",
          "3018507299",
          "3021013122",
          "3008788129",
          "9681410",
          "3014579161",
          "3015443199",
          "1058584",
          "3003403221",
          "1649690",
          "3015134081",
          "3004080548",
          "3010763707",
          "3012050423",
          "8043484",
          "3034669683",
          "9616083",
          "9613418",
          "3010395155",
          "3012706495",
          "9617198",
          "3008262278",
          "3041329419",
          "3005327291",
          "1450221",
          "3009655869",
          "3025430795",
          "3003965134",
          "3005621808",
          "9680222",
          "3030398124",
          "3013530901",
          "3008044603",
          "1000317571",
          "3030733800",
          "3012910884",
          "3013863160",
          "3013509849",
          "3031582449",
          "3010034780",
          "3008806809",
          "3006450239",
          "3012002722",
          "3010221586",
          "3008573567",
          "3013298431",
          "3007125392",
          "3042277868",
          "3026331889",
          "3016615875",
          "3038472982",
          "3010162618",
          "3045058049",
          "3044921221"
        ],
        "fei_number": [
          "3023339256",
          "3031184338",
          "3011814545",
          "3010621964",
          "3011495142",
          "3011987967",
          "3006554788",
          "3031590640",
          "3010198795",
          "3003154916",
          "3007417132",
          "3010370474",
          "3014351477",
          "3015142802",
          "3010827261",
          "3006517436",
          "3012034017",
          "3019865496",
          "3007028040",
          "3001451826",
          "3038624153",
          "3011529314",
          "3006897996",
          "3012680643",
          "3006402425",
          "3016758972",
          "3010160370",
          "3003814961",
          "2433012",
          "3011191255",
          "3010131137",
          "3048248080",
          "3000247987",
          "3042283853",
          "3017896419",
          "3030226295",
          "3018507299",
          "3021013122",
          "3008788129",
          "3014579161",
          "3015443199",
          "3003403221",
          "1000219637",
          "3001044237",
          "3015134081",
          "3004080548",
          "3010763707",
          "3012050423",
          "3926",
          "3002808194",
          "3034669683",
          "3002806731",
          "3010395155",
          "3012706495",
          "3008262278",
          "3041329419",
          "3005327291",
          "1450221",
          "3009655869",
          "3025430795",
          "3003264198",
          "3003965134",
          "3005621808",
          "3030398124",
          "3013530901",
          "3008044603",
          "1000317571",
          "3030733800",
          "3012910884",
          "3013863160",
          "3013509849",
          "3031582449",
          "3010034780",
          "3008806809",
          "1000339531",
          "3006450239",
          "3012002722",
          "3003202124",
          "3010221586",
          "3008573567",
          "3013298431",
          "3007125392",
          "3042277868",
          "3026331889",
          "3016615875",
          "3038472982",
          "3010162618",
          "1000612470",
          "3045058049",
          "3044921221"
        ],
        "device_name": "Bag, Drainage, With Adhesive, Ostomy",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5900",
        "device_class": "1"
      }
    }
  ]
}