{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98333",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "address_2": "N/A",
      "postal_code": "60093-2753",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-1465-2026",
      "product_description": "Convenience kits used for dialysis maintenance    Medline ADD A CATH DIALYSIS KIT  SKU ECVC8415A    Centurion CENTRAL LINE INSERTION TRAY  SKU DT19810    Centurion DIALYSIS BUNDLE WITH NO CATHETTER  SKU CVI4310A    Medline DIALYSIS CAP CHANGE KIT  SKU DYNDC2425    Medline DIALYSIS CHANGE KIT  SKU EBSI1453A    Centurion HEMODIALYSIS ACCESS KIT  SKU DT12970    Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT  SKU EBSI1741",
      "product_quantity": "14,525",
      "reason_for_recall": "Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.",
      "recall_initiation_date": "20260108",
      "center_classification_date": "20260224",
      "report_date": "20260304",
      "code_info": "Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A UDI-DI (ea) 10653160383628 UDI-DI (case) 00653160383621 Kit lots 2024121390 2025033190  Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 UDI-DI (ea) 10653160368755 UDI-DI (case) 00653160368758 Kit lot 2025041090  Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A UDI-DI (ea) 10653160374978 UDI-DI (case) 00653160374971 Kit lots 2024051490 2025021290 2025051390 2025091090  Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 UDI-DI (ea) 10653160375845 UDI-DI (case) 00653160375848 Kit lots 2024060690 2024101690 2024103190 2025010890 2025040190  Medline DIALYSIS CHANGE KIT SKU EBSI1453A UDI-DI (ea) 10653160383475 UDI-DI (case) 00653160383478 Kit lots 2024050790 2024051390 2024082290 2024111990 2025013090 2025032090 2025050190 2025062790  Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 UDI-DI (ea) 10653160368922 UDI-DI (case) 00653160368925 Kit lots 2025040401 2025081401  Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741 UDI-DI (ea) 10653160374527 UDI-DI (case) 00653160374520 Kit lots 2024061780 2024070180 2024081280 2024111290 2025012490 2025032690 2025051390 2025061790 2025071490 2025072190"
    }
  ]
}