{
  "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": "2026-03-18",
    "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": "92466",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "address_2": "N/A",
      "postal_code": "60093-2753",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.",
      "recall_number": "Z-2181-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tBLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755;  b)\tVNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4;  c)\tULTRASOUND PIV BUNDLE, Model Number IV8635D;  d)\tULTRASOUND GUIDED PIV KIT, Model Number IVS3300;  e)\tULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A;  f)\tEPIV PROCEDURE TRAY, Model Number IVS3825;  g)\tULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A;  h)\tRADIOLOGY TRAY, Model Number MNS11625;  i)\tBEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A;  j)\tNGHS EVOR ANGIO PACK, Model Number NG410A;  k)\tPICC INSERT KIT-LESS THAN 3 FR, Model Number PHS41739A;  l)\tRADIOLOGY SPECIALS PACK, Model Number PHS479840M;  m)\tHYBRID OR PACK, Model Number SYNJ10303B;  n)\tTVS4500 MULTI PURPOSE VEIN, Model Number TVS4500A;  o)\tTVS4500 MULTI PURPOSE VEIN, Model Number TVS4500B;  p)\tVC PROCEDURE KIT, Model Number VC-PK",
      "product_quantity": "# included in 3,740,814 units total",
      "reason_for_recall": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
      "recall_initiation_date": "20230518",
      "center_classification_date": "20230720",
      "report_date": "20230726",
      "code_info": "all lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Number DYNJRA1755, UDI/DI (EA) 10193489842845, UDI/DI (CS) 40193489842846;  b) Model Number DYNJTESTCFP4, UDI/DI (EA) 10193489472813, UDI/DI (CS) 40193489472814;  c) Model Number IV8635D, UDI/DI (EA) 10653160990260, UDI/DI (CS) 40653160990261;  d) Model Number IVS3300, UDI/DI (EA) 10653160307662, UDI/DI (CS) 40653160307663;  e) Model Number IVS3485A, UDI/DI (EA) 10653160990154, UDI/DI (CS) 40653160990155;  f) Model Number IVS3825, UDI/DI (EA) 10653160330752, UDI/DI (CS) 40653160330753;  g) Model Number IVS3840A, UDI/DI (EA) 10193489476736, UDI/DI (CS) 40193489476737;  h) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 40653160322130;  i) Model Number MNS7695A, UDI/DI (EA) 10653160343455, UDI/DI (CS) 40653160343456;  j) Model Number NG410A, UDI/DI (EA) 10889942945887, UDI/DI (CS) 40889942945888;  k) Model Number PHS41739A, UDI/DI (EA) 10889942906802, UDI/DI (CS) 40889942906803;  l) Model Number PHS479840M, UDI/DI (EA) 10193489682724, UDI/DI (CS) 40193489682725;  m) Model Number SYNJ10303B, UDI/DI (EA) 10193489373745, UDI/DI (CS) 40193489373746;  n) Model Number TVS4500A, UDI/DI (EA) 10816982023374, UDI/DI (CS) 40816982023375;  o) Model Number TVS4500B, UDI/DI (EA) 10195327223564, UDI/DI (CS) 40195327223565;  p) Model Number VC-PK, UDI/DI (EA) 10195327176891, UDI/DI (CS) 40195327176892;",
      "more_code_info": ""
    }
  ]
}