{
  "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": "2026-10-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Warwick",
      "state": "RI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99545",
      "recalling_firm": "Criticare Technologies, Inc.",
      "address_1": "333 Strawberry Field Rd Ste 11",
      "address_2": "",
      "postal_code": "02886-2459",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the states and territory of AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, PA,  RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and Puerto Rico.",
      "recall_number": "Z-3253-2026",
      "product_description": "nGenuity Patient Monitor with Capnography (ETCO2)    CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R",
      "product_quantity": "1,007",
      "reason_for_recall": "Complaint trend where \"Checkline Error\" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.",
      "recall_initiation_date": "20260506",
      "center_classification_date": "20260922",
      "report_date": "20260930",
      "code_info": "UDI-DI +B4388100EP1US02  All units with CO2 option SN beginning with 424, 125, 225, 325, 425, 126, 226, 326, 426, date range 2024-1st qt 2026",
      "more_code_info": ""
    }
  ]
}