{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Sunrise",
      "state": "FL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98729",
      "recalling_firm": "Bolton Medical Inc.",
      "address_1": "799 International Pkwy",
      "address_2": "",
      "postal_code": "33325-6220",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.",
      "recall_number": "Z-2160-2026",
      "product_description": "RelayPro Thoracic Stent-Graft System (various sizes)  Reference numbers: 28-N4-32-104-32U\t28-N4-32-164-28U\t28-N4-32-164-32U\t28-N4-32-209-28U\t28-N4-32-209-32U\t28-N4-32-259-32U\t28-N4-34-109-34U\t28-N4-34-154-30U\t28-N4-34-154-34U\t28-N4-34-209-30U\t28-N4-34-209-34U\t28-N4-34-259-34U\t28-N4-36-109-36U\t28-N4-36-154-32U\t28-N4-36-154-36U\t28-N4-36-199-32U\t28-N4-36-199-36U\t28-N4-36-259-36U\t28-N4-38-109-38U\t28-N4-38-154-34U\t28-N4-38-154-38U\t28-N4-38-199-34U\t28-N4-38-199-38U\t28-N4-38-259-38U\t28-N4-40-114-40U\t28-N4-40-154-36U\t28-N4-40-154-40U\t28-N4-40-204-36U\t28-N4-40-204-40U\t28-N4-40-259-40U\t28-N4-42-114-42U\t28-N4-42-159-38U\t28-N4-42-159-42U\t28-N4-42-204-38U\t28-N4-42-204-42U\t28-N4-42-259-42U\t28-N4-44-114-44U\t28-N4-44-164-40U\t28-N4-44-164-44U\t28-N4-44-209-40U\t28-N4-44-209-44U\t28-N4-44-259-40U\t28-N4-44-259-44U\t28-N4-46-114-46U\t28-N4-46-164-42U\t28-N4-46-164-46U\t28-N4-46-209-42U\t28-N4-46-209-46U\t28-N4-46-259-42U",
      "product_quantity": "",
      "reason_for_recall": "Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.",
      "recall_initiation_date": "20260422",
      "center_classification_date": "20260522",
      "report_date": "20260603",
      "code_info": "All Lots/(Ref Number/Proximal Diameter/DI)28-N4-32-104-32U/ 32/ (01)00843576150461; 28-N4-32-164-28U/ 32/ (01)00843576150959; 28-N4-32-164-32U/ 32/ (01)00843576150591; 28-N4-32-209-28U/ 32/ (01)00843576151055; 28-N4-32-209-32U/ 32/ (01)00843576150720; 28-N4-32-259-32U/ 32/ (01)00843576150850; 28-N4-34-109-34U/ 34/ (01)00843576150478; 28-N4-34-154-30U/ 34/ (01)00843576150966; 28-N4-34-154-34U/ 34/ (01)00843576150607; 28-N4-34-209-30U/ 34/ (01)00843576151062; 28-N4-34-209-34U/ 34/ (01)00843576150737; 28-N4-34-259-34U/ 34/ (01)00843576150867; 28-N4-36-109-36U/ 36/ (01)00843576150485; 28-N4-36-154-32U/ 36/ (01)00843576150973; 28-N4-36-154-36U/ 36/ (01)00843576150614; 28-N4-36-199-32U/ 36/ (01)00843576151079; 28-N4-36-199-36U/ 36/ (01)00843576150744; 28-N4-36-259-36U/ 36/ (01)00843576150874; 28-N4-38-109-38U/ 38/ (01)00843576150492; 28-N4-38-154-34U/ 38/ (01)00843576150980; 28-N4-38-154-38U/ 38/ (01)00843576150621; 28-N4-38-199-34U/ 38/ (01)00843576151086; 28-N4-38-199-38U/ 38/ (01)00843576150751; 28-N4-38-259-38U/ 38/ (01)00843576150881; 28-N4-40-114-40U/ 40/ (01)00843576150508; 28-N4-40-154-36U/ 40/ (01)00843576150997; 28-N4-40-154-40U/ 40/ (01)00843576150638; 28-N4-40-204-36U/ 40/ (01)00843576151093; 28-N4-40-204-40U/ 40/ (01)00843576150768; 28-N4-40-259-40U/ 40/ (01)00843576150898; 28-N4-42-114-42U/ 42/ (01)00843576150515; 28-N4-42-159-38U/ 42/ (01)00843576151000; 28-N4-42-159-42U/ 42/ (01)00843576150645; 28-N4-42-204-38U/ 42/ (01)00843576151109; 28-N4-42-204-42U/ 42/ (01)00843576150775; 28-N4-42-259-42U/ 42/ (01)00843576150904; 28-N4-44-114-44U/ 44/ (01)00843576150522; 28-N4-44-164-40U/ 44/ (01)00843576151017; 28-N4-44-164-44U/ 44/ (01)00843576150652; 28-N4-44-209-40U/ 44/ (01)00843576151116; 28-N4-44-209-44U/ 44/ (01)00843576150782; 28-N4-44-259-40U/ 44/ (01)00843576151215; 28-N4-44-259-44U/ 44/ (01)00843576150911; 28-N4-46-114-46U/ 46/ (01)00843576150539; 28-N4-46-164-42U/ 46/ (01)00843576151024; 28-N4-46-164-46U/ 46/ (01)00843576150669; 28-N4-46-209-42U/ 46/ (01)00843576151123; 28-N4-46-209-46U/ 46/ (01)00843576150799; 28-N4-46-259-42U/ 46/ (01)00843576151222",
      "more_code_info": ""
    }
  ]
}