{
  "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": "2026-08-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Wilmington",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98777",
      "recalling_firm": "Spectra Medical Devices, Llc",
      "address_1": "299 Ballardvale St",
      "address_2": "Ste 1",
      "postal_code": "01887-1066",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.",
      "recall_number": "Z-2873-2026",
      "product_description": "Brand Name: Elevaris/Spectra Medical Devices  Product Name: Sodium Chloride Injection, 0.9%, USP 10mL  Ampule  Model/Catalog Number: AMPUL10MLK.     Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.",
      "product_quantity": "TBD",
      "reason_for_recall": "Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.",
      "recall_initiation_date": "20260706",
      "center_classification_date": "20260811",
      "report_date": "20260819",
      "code_info": "Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton)    Lots:  AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008  No individual UDI, as this product is used only within convenience kits.",
      "more_code_info": ""
    }
  ]
}