{
  "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": "62551",
      "code_info": "49349Q  49350Q  49351Q  49352Q  49799Q  49800Q  49801Q  49802Q  49809Q  49849Q  49850Q  49851Q  50392Q  50393Q  50492Q  50493Q  50494Q  50495Q  50496Q  50497Q  50615Q  50616Q  50868Q  50869Q  50870Q  50871Q  50872Q  50873Q  50874Q  50875Q  50876Q  50877Q  50878Q  50879Q  50880Q  50881Q",
      "center_classification_date": "20210401",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution.",
      "state": "MA",
      "product_description": "BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - 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-1335-2021",
      "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"
    }
  ]
}