{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Mansfield",
      "address_1": "15 Hampshire St",
      "reason_for_recall": "The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.",
      "address_2": "",
      "product_quantity": "62,551",
      "code_info": "46966F  47358F  47359F  47360F  47361F  47362F  47363F  47364F  47365F  47366F  47367F  47368F  47369F  47370F  47371F  47783F  48082F  48083F  48084F  48085F  48086F  48087F  48088F  48090F  48091F  48092F  48437F  48438F  48439F  48440F  48441F  48442F  48443F  48444F  48445F  48446F  48447F  48448F  48449F  48781F  48782F  48783F  49068F  49069F  49070F  49071F  49072F  49073F  49074F  49075F  49076F  49077F  49078F  49079F  49080F  49081F  49082F  49083F  49084F  49366F  49367F  49368F  49369F  49370F  49371F  49372F  49373F  49374F  49375F  49376F  49377F  49378F  49379F  49380F  49381F  49382F  49383F  49384F  49385F  49386F  49387F  49388F  49663F  49664F  49665F  49666F  49667F  49668F  49911F  49912F  49913F  49914F  50197F  50198F  50199F  50285F  50286F  50287F  50297F  50298F  50299F  50300F  50301F  50370F  50371F  50372F  50374F  50375F  50376F  50377F  50378F  50379F  50380F  50489F  50490F  50595F  50596F  50597F  50598F  50599F  50600F  50601F  50602F  50603F  50604F  50605F  50606F  50607F  50608F  50609F  50610F  50848F  50849F  50850F  50851F  50852F  50853F  50854F  51184F  51185F  51186F  51187F  51188F  51190F",
      "center_classification_date": "20210401",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution.",
      "state": "MA",
      "product_description": "CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.",
      "report_date": "20210407",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Covidien Llc",
      "recall_number": "Z-1334-2021",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "87396",
      "more_code_info": "",
      "recall_initiation_date": "20210226",
      "postal_code": "02048-1113",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}