{
  "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": "2026-07-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99061",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 920",
      "address_2": "N/A",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA.",
      "recall_number": "Z-2702-2026",
      "product_description": "5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions.    1. 5008X HD Pre-Flush   Standard Blood Tubing Set; Model Number: 03-5110-6.    2. 5008X HD Pre-Flush   With Twister Blood Tubing Set; Model Number: 03-5160-1.     3. 5008X HD/HDF   Standard Blood Tubing Set; Model Number: 03-5300-3.     4. 5008X HD/HDF   With CLiC Blood Tubing Set; Model Number: 03-5300-3C.     5. 5008X HD/HDF   With Twister Blood Tubing Set; Model Number: 03-5350-8.",
      "product_quantity": "113,544 units (4,731 cases)",
      "reason_for_recall": "Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.",
      "recall_initiation_date": "20260511",
      "center_classification_date": "20260708",
      "report_date": "20260715",
      "code_info": "Sets manufactured after February 26, 2026  1. Model Number: 03-5110-6. UDI-DI: 00840861102556.   2. Model Number: 03-5160-1. UDI-DI: 00840861102563.   3. Model Number: 03-5300-3. UDI-DI: 00840861102518.   4. Model Number: 03-5300-3C. UDI-DI: 00840861102532.   5. Model Number: 03-5350-8. UDI-DI: 00840861102525."
    }
  ]
}