{
  "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": "2026-09-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "222192",
      "product_res_number": "Z-3257-2026",
      "event_date_initiated": "2026-08-03",
      "event_date_posted": "2026-09-23",
      "recall_status": "Open, Classified",
      "res_event_number": "99681",
      "product_code": "NHJ",
      "k_numbers": [
        "K200988"
      ],
      "product_description": "Brand Name: VOLARA System\r\nProduct Name: VOLARA, HC, NA A\r\nModel/Catalog Number: M08594A\r\nSoftware Version: N/A\r\nProduct Description: VOLARA, HOMECARE, NORTH AMERICA\r\nComponent: No",
      "code_info": "Lot Code: UDI: 00887761981690\rSerial Numbers: W078SY3553 and Z309SY7853",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Center for One Baxter\n1-847-9484770",
      "reason_for_recall": "Contamination within the release test equipment flow path could have affected the accuracy of the  nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.",
      "root_cause_description": "Device Design",
      "action": "Affected consignees were notified by phone on August 3, 2026. \n\nCustomers were informed that as a precaution, Baxter would replace impacted VOLARA devices. A Baxter clinical trainer would contact the customers to schedule a home visit to exchange the device. Customers were asked to continue to use the VOLARA device as prescribed until it was exchanged.\n\nAs of August 13, 2026, all potentially affected devices have been returned to Baxter.",
      "product_quantity": "2",
      "distribution_pattern": "US Nationwide distribution in the states of Colorado and Florida.",
      "openfda": {
        "k_number": [
          "K231728",
          "K981726",
          "K132988",
          "K191912",
          "K213564",
          "K253001",
          "K003684",
          "K113549",
          "K124032",
          "K002598",
          "K200988",
          "K982016",
          "K121955",
          "K120277",
          "K140605",
          "K192143",
          "K151689",
          "K924174",
          "K140598",
          "K242438",
          "K905236",
          "K781232",
          "K051964",
          "K895485",
          "K260604",
          "K072292"
        ],
        "device_name": "Device, Positive Pressure Breathing, Intermittent",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5905",
        "device_class": "2",
        "registration_number": [
          "3006534321",
          "3020562909",
          "2518422",
          "3018783526",
          "3029227324",
          "9617566",
          "3021244152",
          "3007123976",
          "3008700378",
          "3009987158",
          "3006087789",
          "3017520736",
          "3013095415",
          "3008145987",
          "3003589956",
          "3017373426",
          "2951529",
          "2183816",
          "3016774528",
          "3004050971",
          "3029845",
          "3006240053",
          "3010834934",
          "3023272766",
          "3000126629",
          "1000604079",
          "3010817335",
          "3006446479",
          "3011120183"
        ],
        "fei_number": [
          "3006534321",
          "3020562909",
          "2518422",
          "3018783526",
          "3029227324",
          "3021244152",
          "3007123976",
          "3008700378",
          "3009987158",
          "3006087789",
          "3017520736",
          "3013095415",
          "3008145987",
          "3003589956",
          "3017373426",
          "2183816",
          "3016774528",
          "3004050971",
          "3006240053",
          "3010834934",
          "3023272766",
          "3000126629",
          "1000604079",
          "3010817335",
          "3003244771",
          "1000524541",
          "3006446479",
          "1000307109",
          "3011120183"
        ]
      }
    }
  ]
}