{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Winston Salem",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93326",
      "recalling_firm": "Wilson-Cook Medical Inc.",
      "address_1": "4900 Bethania Station Rd",
      "address_2": "",
      "postal_code": "27105-1203",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US",
      "recall_number": "Z-0462-2024",
      "product_description": "QUANTUM TTC BILIARY BALLOON DILATOR, REF  QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree",
      "product_quantity": "888 devices",
      "reason_for_recall": "Nonconforming devices while manufactured correctly, do not comply to their design requirements.  Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.",
      "recall_initiation_date": "20231103",
      "center_classification_date": "20231201",
      "report_date": "20231213",
      "code_info": "UDI/DI 00827002226562 (each), 10827002226569 (case), Lot Numbers:  W4737768, W4746516, W4746916, W4747433, W4747834, W4748247, W4748468, W4748476, W4748944, W4749747, W4750013, W4751335, W4754263, W4756372, W4757274, W4720844, W4721266, W4721791, W4722154, W4722156, W4722983, W4722985, W4724319, W4724691, W4737429, W4737766, W4738716, W4740112, W4746518, W4746918, W4747435, W4747436, W4748248, W4748467, W4748963, W4749746, W4750869, W4751107, W4751110, W4751516, W4752277, W4752278, W4752280, W4752905, W4754118, W4754254, W4754257, W4756474, W4757277, W4758165, W4760467, W4760864, W4761747, W4762155",
      "more_code_info": ""
    }
  ]
}