{
  "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": "Waukegan",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97539",
      "recalling_firm": "Cardinal Health 200, LLC",
      "address_1": "3651 Birchwood Dr",
      "address_2": "",
      "postal_code": "60085-8337",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.",
      "recall_number": "Z-0206-2026",
      "product_description": "Salem Sump PVC Tubes:    Product Code/Product Name:    8888264911E\tENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN  8888264929E\tENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN  8888264945E\tENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN  8888264960E\tENFit\" Salem Sump\" PVC Tube 16Fr 48IN  8888264986E\tENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN  8888266106E\tPVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN  8888266114E\tPVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN  8888266122E\tPVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN  8888266130E\tPVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN  8888266148E\tPVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN  8888268060E\tENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN  8888268086E\tENFit\" Salem Sump\" PVC Tube 8Fr 24IN",
      "product_quantity": "all lots",
      "reason_for_recall": "Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.",
      "recall_initiation_date": "20250918",
      "center_classification_date": "20251017",
      "report_date": "20251029",
      "code_info": "Product Code/Product Name/UDI-DI:  8888264911E ENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN 10884521779419 8888264929E ENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN 10884521779426 8888264945E ENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN 10884521779433 8888264960E ENFit\" Salem Sump\" PVC Tube 16Fr 48IN 10884521779440 8888264986E ENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN 10884521779457 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 10192253012774 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 10192253012798 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 10192253012811 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 10192253012835 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 10192253012859 8888268060E ENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN 10884521779464 8888268086E ENFit\" Salem Sump\" PVC Tube 8Fr 24IN 10884521779471  All Lots",
      "more_code_info": ""
    }
  ]
}