{
  "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-2199-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tFEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005;   b)\t20GX6\" FEMORAL ART LINE KIT, Model Number ART1165;   c)\t3\" RADIAL ARTERIAL LINE KIT, Model Number ART240A;   d)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245A;   e)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245B;   f)\tARTERIAL LINE BUNDLE, Model Number ART255;   g)\tARTERIAL LINE BUNDLE, Model Number ART560;   h)\tA LINE TRAY, Model Number ART690;   i)\tARTERIAL LINE TRAY, Model Number ART840;   j)\t18GX6\" FEMORAL ART LINE KIT, Model Number ART960;   k)\t20Gx3\" RADIAL ART LINE KIT, Model Number ART970;   l)\tBIOPSY/ASPIRATION TRAY, Model Number BT235A;   m)\tPERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825;   n)\tPICC INSERTION KIT, Model Number CVI3735;   o)\tPICC INSERTION BUNDLE, Model Number CVI4025A;   p)\tVASCULAR ACCESS  INSERTION KIT, Model Number CVI4180;   q)\tVASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265;   r)\tUNIVERSAL CVC ZONE DEFENSE BUNDLE, Model Number CVI4430;   s)\tPEDIATRIC PICC INSERTION TRAY, Model Number CVI4450A;   t)\tCVC ACCESSORY BUNDLE, Model Number CVI4505;   u)\tDIALYSIS/CVC BUNDLE W/O CATHETER, Model Number CVI4655;   v)\tFISHLINE KIT, Model Number CVI4725;   w)\tVENOUS ACCESS TRAY, Model Number CVI4830A;   x)\tVENOUS ACCESS TRAY, Model Number CVI4830B;   y)\tCVC INSERTION BUNDLE- ADD A CATHETER, Model Number CVI4905;   z)\tMVHS CVC LUMEN TRAY, Model Number CVI4920;   aa)\tART LINE SECUREMENT KIT W/LIDOCAINE, Model Number DT22570A;   bb)\tADULT VASCULAR ACCESS BUNDLE, Model Number DT22860;   cc)\tTOTE MCADAMS OSC SHLDR ARTHRO, Model Number DYKM1790A;   dd)\tMAX BARRIER KIT, Model Number DYND2673B;   ee)\tTHYROID FNA TRAY, Model Number DYNDA2238A;   ff)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;   gg)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   hh)\tULTRASOUND BIOPSY, Model Number DYNDH1542;   ii)\tBIOPSY TRAY, Model Number DYNDH1661;   jj)\tUSG PIV KIT, Model Number DYNDV2536A;   kk)\tULTRASOUND IV ACCESS PACK - LF, Model Number DYNJ0182378B;   ll)\tPORT INSERTION KIT, Model Number MNS11590;   mm)\tRADIOLOGY TRAY, Model Number MNS11625;   nn)\tBEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number MNS12065;   oo)\tINTRA PROBE COVER 5X96 KIT, Model Number P155598;   pp)\tULTRASOUND PROBE KIT, Model Number P482986;   qq)\tARTHROGRAM TRAY, Model Number SPEC0232;   rr)\tULTRA CORE BIOPSY KIT, Model Number SPEC0291B;",
      "product_quantity": "39391 units",
      "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 ART1005, UDI/DI (EA) 10193489198232, UDI/DI (CS) 20193489198239;  b) Model Number ART1165, UDI/DI (EA) 10653160354680, UDI/DI (CS) 00653160354683;  c) Model Number ART240A, UDI/DI (EA) 10653160328025, UDI/DI (CS) 00653160328028;  d) Model Number ART245A, UDI/DI (EA) 10653160328018, UDI/DI (CS) 00653160328011;  e) Model Number ART245B, UDI/DI (EA) 10653160358442, UDI/DI (CS) 00653160358445;  f) Model Number ART255, UDI/DI (EA) 10653160311997, UDI/DI (CS) 00653160311990;  g) Model Number ART560, UDI/DI (EA) 10653160310822, UDI/DI (CS) 00653160310825;  h) Model Number ART690, UDI/DI (EA) 10653160318019, UDI/DI (CS) 00653160318012;  i) Model Number ART840, UDI/DI (EA) 10653160322924, UDI/DI (CS) 00653160322927;  j) Model Number ART960, UDI/DI (EA) 10193489190915, UDI/DI (CS) 20193489190912;  k) Model Number ART970, UDI/DI (EA) 10193489190922, UDI/DI (CS) 20193489190929;  l) Model Number BT235A, UDI/DI (EA) 10653160315919, UDI/DI (CS) 00653160315912;  m) Model Number CHT1825, UDI/DI (EA) 10653160328988, UDI/DI (CS) 00653160328981;  n) Model Number CVI3735, UDI/DI (EA) 10653160261544, UDI/DI (CS) 00653160261547;  o) Model Number CVI4025A, UDI/DI (EA) 10193489396058, UDI/DI (CS) 40193489396059;  p) Model Number CVI4180, UDI/DI (EA) 10653160284451, UDI/DI (CS) 00653160284454;  q) Model Number CVI4265, UDI/DI (EA) 10653160291268, UDI/DI (CS) 00653160291261;  r) Model Number CVI4430, UDI/DI (EA) 10653160314370, UDI/DI (CS) 00653160314373;  s) Model Number CVI4450A, UDI/DI (EA) 10653160320517, UDI/DI (CS) 00653160320510;  t) Model Number CVI4505, UDI/DI (EA) 10653160319047, UDI/DI (CS) 00653160319040;  u) Model Number CVI4655, UDI/DI (EA) 10193489190373, UDI/DI (CS) 20193489190370;  v) Model Number CVI4725, UDI/DI (EA) 10193489199871, UDI/DI (CS) 20193489199878;  w) Model Number CVI4830A, UDI/DI (EA) 10653160353553, UDI/DI (CS) 00653160353556;  x) Model Number CVI4830B, UDI/DI (EA) 10653160358534, UDI/DI (CS) 00653160358537;  y) Model Number CVI4905, UDI/DI (EA) 10653160355618, UDI/DI (CS) 00653160355611;  z) Model Number CVI4920, UDI/DI (EA) 10653160355847, UDI/DI (CS) 00653160355840;  aa) Model Number DT22570A, UDI/DI (EA) 10653160346074, UDI/DI (CS) 00653160346077;  bb) Model Number DT22860, UDI/DI (EA) 10653160359142, UDI/DI (CS) 00653160359145;  cc) Model Number DYKM1790A, UDI/DI (EA) 10193489112412, UDI/DI (CS) 20193489112419;  dd) Model Number DYND2673B, UDI/DI (EA) 10193489191394, UDI/DI (CS) 20193489191391;  ee) Model Number DYNDA2238A, UDI/DI (EA) 10193489191554, UDI/DI (CS) 20193489191551;  ff) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 20193489111245;  gg) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 20193489197089;  hh) Model Number DYNDH1542, UDI/DI (EA) 10193489197396, UDI/DI (CS) 20193489197393;  ii) Model Number DYNDH1661, UDI/DI (EA) 10193489111521, UDI/DI (CS) 20193489111528;  jj) Model Number DYNDV2536A, UDI/DI (EA) 10653160357872, UDI/DI (CS) 00653160357875;  kk) Model Number DYNJ0182378B, UDI/DI (EA) 10653160338536, UDI/DI (CS) 00653160338539;  ll) Model Number MNS11590, UDI/DI (EA) 10653160321293, UDI/DI (CS) 00653160321296;  mm) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 00653160322132;  nn) Model Number MNS12065, UDI/DI (EA) 10653160331193, UDI/DI (CS) 00653160331196;  oo) Model Number P155598, UDI/DI (EA) 10888277902237, UDI/DI (CS) 40888277902238;  pp) Model Number P482986, UDI/DI (EA) 10888277903630, UDI/DI (CS) 40888277903631;  qq) Model Number SPEC0232, UDI/DI (EA) 10888277507418, UDI/DI (CS) 40888277507419;  rr) Model Number SPEC0291B, UDI/DI (EA) 10889942453054, UDI/DI (CS) 40889942453055;",
      "more_code_info": ""
    }
  ]
}