{
  "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": "San Clemente",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97698",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "951 Calle Amanecer",
      "address_2": "",
      "postal_code": "92673-6212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign) to countries of: Canada, Australia, and New Zealand.",
      "recall_number": "Z-0154-2026",
      "product_description": "IV Administration sets.    23\" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359;  23\" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213;  70\" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732;  80\" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733;  53 cm (21\") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014",
      "product_quantity": "23203",
      "reason_for_recall": "IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.",
      "recall_initiation_date": "20251002",
      "center_classification_date": "20251023",
      "report_date": "20251029",
      "code_info": "REF/UDI-DI/Lot: B33359/10887709007823/14070544, 14126963; B9213/10840619045859/14130197; B9732/10887709015033/14149636; B9733/10887709015040/14176779; 011-C7014/10840619005068/14029638, 14065820, 14110075, 14211300, 14129823",
      "more_code_info": ""
    }
  ]
}