{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "222013",
      "product_res_number": "Z-3090-2026",
      "event_date_initiated": "2026-08-06",
      "event_date_posted": "2026-09-11",
      "recall_status": "Open, Classified",
      "res_event_number": "99626",
      "product_code": "FFT",
      "product_description": "Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, \r\n\r\nBravo CF capsule delivery device, 1-pack, Product Number FGS-0636.  Used to attach a pH monitoring capsule to the esophagus.",
      "code_info": "Product Number FGS-0635\nUDI-DI (GTIN) 07290101369707\n\nProduct Number FGS-0636\nUDI-DI (GTIN) 07290101369714\n\nExpiration dates prior to and including October 20, 2027 (lot numbers from 64553F up to and including 68912F)",
      "firm_fei_number": "3003348376",
      "recalling_firm": "Given Imaging Ltd.",
      "address_1": "New Industrial Park 2 Hacarmel St. Ta Do'Ar",
      "city": "Yokne'Am Ilit",
      "postal_code": "258",
      "country": "Israel",
      "additional_info_contact": "Sabrina Zimring\n720-7743454",
      "reason_for_recall": "Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On August 10, 2026, the firm notified consignees via \"URGENT: MEDICAL DEVICE RECALL\" letters.\n\nPlease note this is a separate recall from that initiated in June 2025, which involved the same issue, but a different underlying cause.\n\nCustomers were instructed to do the following:\n\n1. Immediately identify and quarantine all unused and affected devices.\n2. Return all product to Medtronic for replacement as described in the letter.\n3. Complete and return the included customer response form to the firm via email: rs.gmbmitgfca@medtronic.com, even if you do not have unused affected inventory.\n4. Notify all those who need to be aware within your organization, or those to whom affected product was transferred/distributed.\n5. Maintain a copy of the recall letter for your records.\n\nIf you have any questions regarding this communication, please contact your local Medtronic Representative or call 720-774-3454.",
      "product_quantity": "127,416",
      "distribution_pattern": "Worldwide distribution. US nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Czech Republic, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Luxembourg, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, and United Kingdom.",
      "openfda": {
        "k_number": [
          "K822815",
          "K920849",
          "K881706",
          "K914624",
          "K811083",
          "K862727",
          "K820566",
          "K931963",
          "K883234",
          "K862536",
          "K850074",
          "K834512",
          "K891410",
          "K872929",
          "K911825",
          "K874710",
          "K883960",
          "K903646",
          "K875369",
          "K854514",
          "K850361",
          "K852289",
          "K870606",
          "K002028",
          "K925405",
          "K910694",
          "K842690",
          "K853280",
          "K874709",
          "K863298",
          "K871922",
          "K955018",
          "K912772",
          "K102543",
          "K013951",
          "K871921",
          "K841384",
          "K945069",
          "K913387",
          "K853648",
          "K862929",
          "K871282",
          "K896288",
          "K934434",
          "K850778",
          "K961346",
          "K950087",
          "K913817",
          "K902366"
        ],
        "registration_number": [
          "9710107",
          "3011219572",
          "3039167637",
          "2023374",
          "3016854619",
          "3018094310",
          "3007662958",
          "3009106214"
        ],
        "fei_number": [
          "3011219572",
          "3039167637",
          "2023374",
          "3003348376",
          "3016854619",
          "3018094310",
          "3007662958",
          "3009106214"
        ],
        "device_name": "Electrode, Ph, Stomach",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1400",
        "device_class": "1"
      }
    }
  ]
}