{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bethlehem",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97816",
      "recalling_firm": "B Braun Medical Inc",
      "address_1": "824 12th Ave",
      "address_2": "N/A",
      "postal_code": "18018-3524",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.",
      "recall_number": "Z-0661-2026",
      "product_description": "IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.  Labeled as the following with corresponding catalog number:    1. IV ADMIN SET W/ 2 CARESITE, 140 IN; Catalog Number: 490309.",
      "product_quantity": "259,392 units",
      "reason_for_recall": "Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).",
      "recall_initiation_date": "20251029",
      "center_classification_date": "20251126",
      "report_date": "20251203",
      "code_info": "1. Catalog Number: 490309; Primary UDI-DI: 04046964527517; Unit of Dose UDI-DI: 04046964527500.",
      "more_code_info": ""
    }
  ]
}