{
  "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-2179-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tNO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115;  b)\tMAJOR VASCULAR, Model Number CDS980752I;  c)\tPICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F;  d)\tPICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F;  e)\tCHP TRANSPLANT CDS, Model Number CDS983082J;  f)\tCLOSURE CDS, Model Number CDS983704I;  g)\tMIDLINE INSERTION TRAY, Model Number CVI4340;  h)\tPORT INSERTION PACK, Model Number CVI4765;  i)\tMAX BARRIER KIT, Model Number DYND2673B;  j)\tPOWERGLIDE PLACEMENT KIT, Model Number DYNDA1468C;  k)\tDEPIPPO PACK, Model Number DYNDA2011B;  l)\tVEIN PROCEDURE KIT, Model Number DYNDA2076;  m)\tSCLEROTHERAPY KIT, Model Number DYNDA2148A;  n)\tIR SONO PACK, Model Number DYNDA2365B;  o)\tULTRASOUND BASIC KIT, Model Number DYNDC2099;  p)\tPIV WITH ULTRASOUND KIT, Model Number DYNDC2399A;  q)\tPARA THORACENTESIS TRAY, Model Number DYNDH1165A;  r)\tULTRASOUND TRAY, Model Number DYNDH1204;  s)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1292;  t)\tULTRASOUND GUIDE BREAST BIOPSY, Model Number DYNDH1319;  u)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;  v)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470C;  w)\tUS GUIDED LOC KIT, Model Number DYNDH1492;  x)\tAMINO KIT, Model Number DYNDH1649;  y)\tBREAST ULTRASOUND PROCEDURE TR, Model Number DYNDL1596A;  z)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDV2038B;  aa)\tULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385A;  bb)\tCVL PACK, Model Number DYNJ00281N;  cc)\tFEM POP PACK, Model Number DYNJ01964M;  dd)\tMAXIMUM BARRIER PACK-LF, Model Number DYNJ0248546D;  ee)\tVEIN PACK, Model Number DYNJ0309084D;  ff)\tDR. BAHDOUCH PACK, Model Number DYNJ0351069;  gg)\tANGIO STANDARD PACK-LF, Model Number DYNJ0370436Q;  hh)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535Y;  ii)\tJUDKINS PACK-LF, Model Number DYNJ0530948AR;  jj)\tJUDKINS PACK-LF, Model Number DYNJ0586030P;  kk)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508Q;  ll)\tMINI PACK-LF, Model Number DYNJ0604540P;  mm)\tMINI PACK-LF, Model Number DYNJ0604540Q;  nn)\tBIOPSY PACK-LF, Model Number DYNJ0747885F;  oo)\tPERC PACK-LF, Model Number DYNJ0774759O;  pp)\tPERC PACK-LF, Model Number DYNJ0774759P;  qq)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821N;  rr)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821O;  ss)\tCLOSURE PACK-LF, Model Number DYNJ0807503M;  tt)\tLINE PLACEMENT PACK-LF, Model Number DYNJ0931376F;  uu)\tDENTAL PACK-LF, Model Number DYNJ0952428;  vv)\tVENOUS ACCESS TRAY, Model Number DYNJ20094K;  ww)\tDEPAUL IR DIALYSIS PACK, Model Number DYNJ31934D;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ32397B;  yy)\tLARGE PROCEDURE PACK, Model Number DYNJ35524D;  zz)\tRAD CVC TRAY, Model Number DYNJ35574A;  aaa)\tWILDCAT BUNDLE KIT-ADULT, Model Number DYNJ35988J;  bbb)\tWILDCAT BUNDLE KIT-PEDIATRIC, Model Number DYNJ35989G;  ccc)\tSTERILE PICC TRAY-LF, Model Number DYNJ36814B;  ddd)\tPARA/THORA PACK, Model Number DYNJ37280C;  eee)\tBASIC PACK, Model Number DYNJ37460A;  fff)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326F;  ggg)\tMINOR PROCEDURE PACK, Model Number DYNJ38563O;  hhh)\tVEIN PACK, Model Number DYNJ38682C;  iii)\tADULT CVC MAX BARRIER KIT-LF, Model Number DYNJ38714B;  jjj)\tPICC LINE INSERTION, Model Number DYNJ39885A;  kkk)\tPEDIATRIC MAX BARRIER KIT-LF, Model Number DYNJ40306A;  lll)\tHL VEIN STRIPPING PACK, Model Number DYNJ40374A;  mmm)\tGENERAL USE PACK, Model Number DYNJ41137B;  nnn)\tPICC LINE INSERTION WRO-LF, Model Number DYNJ41873B;  ooo)\tCV ACCESS PACK WRO-LF, Model Number DYNJ41875B;  ppp)\tRADIOLOGY PACK, Model Number DYNJ42172A;  qqq)\tBASIC PACK, Model Number DYNJ42691;  rrr)\tDRAINAGE TRAY, Model Number DYNJ42913;  sss)\tDRAINAGE TRAY, Model Number DYNJ42913A;  ttt)\tIR MINI KIT, Model Number DYNJ44519F;  uuu)\tIR PERIPHERAL PACK, Model Number DYNJ45033A;  vvv)\tEVLT CORE PACK, Model Number DYNJ45294;  www)\tEVLT PACK, Model Number DYNJ45997C;  xxx)\tPHLEBECTOMY PACK, Model Number DYNJ47502B;  yyy)\tLINE KIT, Model Number DYNJ47987B;  zzz)\tVEI",
      "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 ARTNC115, UDI/DI (EA) 10653160354338, UDI/DI (CS) 40653160354339;  b) Model Number CDS980752I, UDI/DI (EA) 10889942428540, UDI/DI (CS) 40889942428541;  c) Model Number CDS982858F, UDI/DI (EA) 10888277739215, UDI/DI (CS) 40888277739216;  d) Model Number CDS982859F, UDI/DI (EA) 10888277739208, UDI/DI (CS) 40888277739209;  e) Model Number CDS983082J, UDI/DI (EA) 10193489674514, UDI/DI (CS) 40193489674515;  f) Model Number CDS983704I, UDI/DI (EA) 10193489854558, UDI/DI (CS) 40193489854559;  g) Model Number CVI4340, UDI/DI (EA) 10653160309475, UDI/DI (CS) 40653160309476;  h) Model Number CVI4765, UDI/DI (EA) 10193489953183, UDI/DI (CS) 40193489953184;  i) Model Number DYND2673B, UDI/DI (EA) 10193489564358, UDI/DI (CS) 40193489564359;  j) Model Number DYNDA1468C, UDI/DI (EA) 10889942843176, UDI/DI (CS) 40889942843177;  k) Model Number DYNDA2011B, UDI/DI (EA) 10193489533026, UDI/DI (CS) 40193489533027;  l) Model Number DYNDA2076, UDI/DI (EA) 10889942708505, UDI/DI (CS) 40889942708506;  m) Model Number DYNDA2148A, UDI/DI (EA) 10888277734036, UDI/DI (CS) 40888277734037;  n) Model Number DYNDA2365B, UDI/DI (EA) 10193489836448, UDI/DI (CS) 40193489836449;  o) Model Number DYNDC2099, UDI/DI (EA) 10888277295674, UDI/DI (CS) 40888277295675;  p) Model Number DYNDC2399A, UDI/DI (EA) 10889942446933, UDI/DI (CS) 40889942446934;  q) Model Number DYNDH1165A, UDI/DI (EA) 10889942611508, UDI/DI (CS) 40889942611509;  r) Model Number DYNDH1204, UDI/DI (EA) 10889942519835, UDI/DI (CS) 40889942519836;  s) Model Number DYNDH1292, UDI/DI (EA) 10889942742233, UDI/DI (CS) 40889942742234;  t) Model Number DYNDH1319, UDI/DI (EA) 10889942795475, UDI/DI (CS) 40889942795476;  u) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 40193489111249;  v) Model Number DYNDH1470C, UDI/DI (EA) 10195327297718, UDI/DI (CS) 40195327297719;  w) Model Number DYNDH1492, UDI/DI (EA) 10193489434460, UDI/DI (CS) 40193489434461;  x) Model Number DYNDH1649, UDI/DI (EA) 10193489944365, UDI/DI (CS) 40193489944366;  y) Model Number DYNDL1596A, UDI/DI (EA) 10884389926505, UDI/DI (CS) 40884389926506;  z) Model Number DYNDV2038B, UDI/DI (EA) 10193489919837, UDI/DI (CS) 40193489919838;  aa) Model Number DYNDV2385A, UDI/DI (EA) 10195327298760, UDI/DI (CS) 40195327298761;  bb) Model Number DYNJ00281N, UDI/DI (EA) 10193489449808, UDI/DI (CS) 40193489449809;  cc) Model Number DYNJ01964M, UDI/DI (EA) 10193489648034, UDI/DI (CS) 40193489648035;  dd) Model Number DYNJ0248546D, UDI/DI (EA) 10195327069285, UDI/DI (CS) 40195327069286;  ee) Model Number DYNJ0309084D, UDI/DI (EA) 10889942885268, UDI/DI (CS) 40889942885269;  ff) Model Number DYNJ0351069, UDI/DI (EA) 10889942059058, UDI/DI (CS) 40889942059059;  gg) Model Number DYNJ0370436Q, UDI/DI (EA) 10888277779280, UDI/DI (CS) 40888277779281;  hh) Model Number DYNJ0416535Y, UDI/DI (EA) 10193489994056, UDI/DI (CS) 40193489994057;  ii) Model Number DYNJ0530948AR, UDI/DI (EA) 10195327141882, UDI/DI (CS) 40195327141883;  jj) Model Number DYNJ0586030P, UDI/DI (EA) 10889942947140, UDI/DI (CS) 40889942947141;  kk) Model Number DYNJ0604508Q, UDI/DI (EA) 10193489560190, UDI/DI (CS) 40193489560191;  ll) Model Number DYNJ0604540P, UDI/DI (EA) 10193489560206, UDI/DI (CS) 40193489560207;  mm) Model Number DYNJ0604540Q, UDI/DI (EA) 10193489839685, UDI/DI (CS) 40193489839686;  nn) Model Number DYNJ0747885F, UDI/DI (EA) 10193489542318, UDI/DI (CS) 40193489542319;  oo) Model Number DYNJ0774759O, UDI/DI (EA) 10195327091859, UDI/DI (CS) 40195327091850;  pp) Model Number DYNJ0774759P, UDI/DI (EA) 10195327246136, UDI/DI (CS) 40195327246137;  qq) Model Number DYNJ0785821N, UDI/DI (EA) 10193489915792, UDI/DI (CS) 40193489915793;  rr) Model Number DYNJ0785821O, UDI/DI (EA) 10195327263737, UDI/DI (CS) 40195327263738;  ss) Model Number DYNJ0807503M, UDI/DI (EA) 10889942091737, UDI/DI (CS) 40889942091738;  tt) Model Number DYNJ0931376F, UDI/DI (EA) 10193489271508, UDI/DI (CS) 40193489271509;  uu) Model Number DYNJ0952428, UDI/DI (EA) 10889942101610, UDI/DI (CS) 40889942101611;  vv) Model Number DYNJ20094K, UDI/DI (EA) 10193489213256, UDI/DI (CS) 40193489213257;  ww) Model Number DYNJ31934D, UDI/DI (EA) 10195327071509, UDI/DI (CS) 40195327071500;  xx) Model Number DYNJ32397B, UDI/DI (EA) 10884389916650, UDI/DI (CS) 40884389916651;  yy) Model Number DYNJ35524D, UDI/DI (EA) 10193489766103, UDI/DI (CS) 40193489766104;  zz) Model Number DYNJ35574A, UDI/DI (EA) 10884389538067, UDI/DI (CS) 40884389538068;  aaa) Model Number DYNJ35988J, UDI/DI (EA) 10195327024666, UDI/DI (CS) 40195327024667;  bbb) Model Number DYNJ35989G, UDI/DI (EA) 10195327024673, UDI/DI (CS) 40195327024674;  ccc) Model Number DYNJ36814B, UDI/DI (EA) 10195327075576, UDI/DI (CS) 40195327075577;  ddd) Model Number DYNJ37280C, UDI/DI (EA) 10889942431656, UDI/DI (CS) 40889942431657;  eee) Model Number DYNJ37460A, UDI/DI (EA) 10888277560437, UDI/DI (CS) 40888277560438;  fff) Model Number DYNJ38326F, UDI/DI (EA) 10193489236675, UDI/DI (CS) 40193489236676;  ggg) Model Number DYNJ38563O, UDI/DI (EA) 10193489251746, UDI/DI (CS) 40193489251747;  hhh) Model Number DYNJ38682C, UDI/DI (EA) 10889942897193, UDI/DI (CS) 40889942897194;  iii) Model Number DYNJ38714B, UDI/DI (EA) 10889942601936, UDI/DI (CS) 40889942601937;  jjj) Model Number DYNJ39885A, UDI/DI (EA) 10889942539932, UDI/DI (CS) 40889942539933;  kkk) Model Number DYNJ40306A, UDI/DI (EA) 10889942601929, UDI/DI (CS) 40889942601920;  lll) Model Number DYNJ40374A, UDI/DI (EA) 10888277557949, UDI/DI (CS) 40888277557940;  mmm) Model Number DYNJ41137B, UDI/DI (EA) 10889942260874, UDI/DI (CS) 40889942260875;  nnn) Model Number DYNJ41873B, UDI/DI (EA) 10193489563061, UDI/DI (CS) 40193489563062;  ooo) Model Number DYNJ41875B, UDI/DI (EA) 10193489563078, UDI/DI (CS) 40193489563079;  ppp) Model Number DYNJ42172A, UDI/DI (EA) 10193489502718, UDI/DI (CS) 40193489502719;  qqq) Model Number DYNJ42691, UDI/DI (EA) 10888277003507, UDI/DI (CS) 40888277003508;  rrr) Model Number DYNJ42913, UDI/DI (EA) 10888277013209, UDI/DI (CS) 40888277013200;  sss) Model Number DYNJ42913A, UDI/DI (EA) 10195327080600, UDI/DI (CS) 40195327080601;  ttt) Model Number DYNJ44519F, UDI/DI (EA) 10193489467475, UDI/DI (CS) 40193489467476;  uuu) Model Number DYNJ45033A, UDI/DI (EA) 10193489475807, UDI/DI (CS) 40193489475808;  vvv) Model Number DYNJ45294, UDI/DI (EA) 10888277098978, UDI/DI (CS) 40888277098979;  www) Model Number DYNJ45997C, UDI/DI (EA) 10889942684366, UDI/DI (CS) 40889942684367;  xxx) Model Number DYNJ47502B, UDI/DI (EA) 10193489649222, UDI/DI (CS) 40193489649223;  yyy) Model Number DYNJ47987B, UDI/DI (EA) 10193489867374, UDI/DI (CS) 40193489867375;  zzz) Model Number DYNJ48454, UDI/DI (EA) 10888277595286, UDI/DI (CS) 40888277595287;  aaaa) Model Number DYNJ48456B, UDI/DI (EA) 10889942733170, UDI/DI (CS) 40889942733171;  bbbb) Model Number DYNJ49177F, UDI/DI (EA) 10888277774346, UDI/DI (CS) 40888277774347;  cccc) Model Number DYNJ49737C, UDI/DI (EA) 10195327235888, UDI/DI (CS) 40195327235889;  dddd) Model Number DYNJ51248B, UDI/DI (EA) 10889942873401, UDI/DI (CS) 40889942873402;  eeee) Model Number DYNJ51340D, UDI/DI (EA) 10193489569810, UDI/DI (CS) 40193489569811;  ffff) Model Number DYNJ51638C, UDI/DI (EA) 10195327039561, UDI/DI (CS) 40195327039562;  gggg) Model Number DYNJ51705B, UDI/DI (EA) 10193489877175, UDI/DI (CS) 40193489877176;  hhhh) Model Number DYNJ52122B, UDI/DI (EA) 10193489935301, UDI/DI (CS) 40193489935302;  iiii) Model Number DYNJ52122C, UDI/DI (EA) 10195327260088, UDI/DI (CS) 40195327260089;  jjjj) Model Number DYNJ52171, UDI/DI (EA) 10889942243471, UDI/DI (CS) 40889942243472;  kkkk) Model Number DYNJ53122B, UDI/DI (EA) 10193489321227, UDI/DI (CS) 40193489321228;  llll) Model Number DYNJ53135C, UDI/DI (EA) 10193489468434, UDI/DI (CS) 40193489468435;  mmmm) Model Number DYNJ53319C, UDI/DI (EA) 10193489634495, UDI/DI (CS) 40193489634496;  nnnn) Model Number DYNJ53435C, UDI/DI (EA) 10193489200867, UDI/DI (CS) 40193489200868;  oooo) Model Number DYNJ53482A, UDI/DI (EA) 10889942917310, UDI/DI (CS) 40889942917311;  pppp) Model Number DYNJ53658A, UDI/DI (EA) 10889942684403, UDI/DI (CS) 40889942684404;  qqqq) Model Number DYNJ54131, UDI/DI (EA) 10889942466801, UDI/DI (CS) 40889942466802;  rrrr) Model Number DYNJ54265, UDI/DI (EA) 10889942474004, UDI/DI (CS) 40889942474005;  ssss) Model Number DYNJ54437C, UDI/DI (EA) 10193489243970, UDI/DI (CS) 40193489243971;  tttt) Model Number DYNJ54569A, UDI/DI (EA) 10193489742954, UDI/DI (CS) 40193489742955;  uuuu) Model Number DYNJ54894A, UDI/DI (EA) 10193489213553, UDI/DI (CS) 40193489213554;  vvvv) Model Number DYNJ55063A, UDI/DI (EA) 10193489680546, UDI/DI (CS) 40193489680547;  wwww) Model Number DYNJ55456, UDI/DI (EA) 10889942548446, UDI/DI (CS) 40889942548447;  xxxx) Model Number DYNJ55457, UDI/DI (EA) 10889942548460, UDI/DI (CS) 40889942548461;  yyyy) Model Number DYNJ55458, UDI/DI (EA) 10889942548453, UDI/DI (CS) 40889942548454;  zzzz) Model Number DYNJ55723A, UDI/DI (EA) 10889942865536, UDI/DI (CS) 40889942865537",
      "more_code_info": ""
    }
  ]
}