{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Greensboro",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94121",
      "recalling_firm": "ConvaTec, Inc",
      "address_1": "7815 National Service Rd Ste 600",
      "address_2": "",
      "postal_code": "27409-9403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Italy, UK.",
      "recall_number": "Z-1350-2024",
      "product_description": "Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF):  a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661",
      "product_quantity": "6709 units",
      "reason_for_recall": "Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.",
      "recall_initiation_date": "20240219",
      "center_classification_date": "20240321",
      "report_date": "20240327",
      "code_info": "a) 423643, UDI/DI 768455203925, Lot Numbers 3L03391;  b) 423658, UDI/DI 768455204076, Lot Numbers 3L04005;  c) 423659, UDI/DI 768455204083, Lot Numbers 3L03670;  d) 423664, UDI/DI 768455204137, Lot Numbers 3L02230;  e) 423666, UDI/DI 768455204151, Lot Numbers 3L04004;  f) 423645, UDI/DI 976845520394, Lot Numbers 3L04989;  g) 423667, UDI/DI 768455204168, Lot Numbers 3L04674;  h) 423657, UDI/DI 768455204069, Lot Numbers 3L04114;  i) 423652, UDI/DI 768455204014, Lot Numbers 3L03669;  j) 423646, UDI/DI 768455203956, Lot Numbers 3M01542;  k) 423654, UDI/DI 768455204038, Lot Numbers 3M00021;  l) 423653, UDI/DI 768455204021, Lot Numbers 3M00786;  m) 423647, UDI/DI 768455203963, Lot Numbers 3M01540;  n) 423644, UDI/DI 768455203932, Lot Numbers 3M01539;  o) 423648, UDI/DI 768455203970, Lot Numbers 3M01541;  p) 423665, UDI/DI 768455204144, Lot Numbers 3M00029;  q) 423656, UDI/DI 768455204052, Lot Numbers 3L00958;  r) 423651, UDI/DI 768455204007, Lot Numbers 3K03888;  s) 423660, UDI/DI 768455204090, Lot Numbers 3M00022;  t) 423661, UDI/DI 768455204106, Lot Numbers 3M00023",
      "more_code_info": ""
    }
  ]
}