{
  "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-2161-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY PACK, Model Number DYNJ55252C;  b)\tCATH LAB PACK, Model Number DYNJ55455A;  c)\tCATH LAB 2, Model Number DYNJ55680A;  d)\tIR ANGIO TRAY, Model Number DYNJ56038A;  e)\tCATH PACK, Model Number DYNJ56547C;  f)\tHYBRID, Model Number DYNJ57049G;  g)\tHYBRID, Model Number DYNJ57049I;  h)\tHYBRID, Model Number DYNJ57049J;  i)\tPERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C;  j)\tGENERAL ANGIO PACK, Model Number DYNJ57760C;  k)\tENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C;  l)\tANGIO PACK, Model Number DYNJ58111D;  m)\tANGIO PACK, Model Number DYNJ58111F;  n)\tPORT PACK, Model Number DYNJ58162;  o)\tENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B;  p)\tPERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A;  q)\tOR ANGIO PACK, Model Number DYNJ59184B;  r)\tPORT A CATH PACK, Model Number DYNJ59307F;  s)\tCATH PACK, Model Number DYNJ59632D;  t)\tPACK PERCUTANEOUS ANGIO  CHRG, Model Number DYNJ60112B;  u)\tI.R. PACK, Model Number DYNJ60343B;  v)\tI.R. PACK, Model Number DYNJ60343C;  w)\tCATH LAB PACK, Model Number DYNJ60763;  x)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082C;  y)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082D;  z)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099B;  aa)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099C;  bb)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118C;  cc)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118D;  dd)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118F;  ee)\tMAIN OR CATH LAB, Model Number DYNJ61373A;  ff)\tCARDIAC CATH PACK-LF, Model Number DYNJ61527A;  gg)\tIR PACK, Model Number DYNJ61646A;  hh)\tPERMA CATH PACK, Model Number DYNJ62007A;  ii)\tIR PACK, Model Number DYNJ62037D;  jj)\tAV FISTULA PACK, Model Number DYNJ62733A;  kk)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ63060B;  ll)\tCATH PACK, Model Number DYNJ63181A;  mm)\tCATH PACK, Model Number DYNJ63181B;  nn)\tCATH PACK, Model Number DYNJ63181C;  oo)\tCATH ANGIO PACK, Model Number DYNJ64050A;  pp)\tANGIOPLASTY PACK-LF, Model Number DYNJ64655C;  qq)\tIR GENERAL PACK, Model Number DYNJ64976;  rr)\tHEART TAVR PACK, Model Number DYNJ65174D;  ss)\tANGIOGRAPHY PACK, Model Number DYNJ65190D;  tt)\tANGIOGRAPHY PACK, Model Number DYNJ65190F;  uu)\tPACK,CARDIAC CATH, Model Number DYNJ65481;  vv)\tRADIOFREQUENCY ABLATION PACK, Model Number DYNJ65913;  ww)\tCATH LAB PACK, Model Number DYNJ66166A;  xx)\tCATH I W SPLIT DRAPE PACK, Model Number DYNJ66182;  yy)\tPORT A CATH INSERT PK, Model Number DYNJ66257;  zz)\tPORT A CATH INSERT PK, Model Number DYNJ66257A;  aaa)\tPORT A CATH INSERT PK, Model Number DYNJ66257B;  bbb)\tFISTULAGRAM PACK, Model Number DYNJ66259A;  ccc)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260A;  ddd)\tCATH PACK, Model Number DYNJ66473A;  eee)\tANGIOGRAPHY PACK, Model Number DYNJ66476A;  fff)\tFEMORAL PACK, Model Number DYNJ66515A;  ggg)\tIR PACK UNION, Model Number DYNJ66926A;  hhh)\tSTANDARD ANGIO TRAY MV, Model Number DYNJ67136A;  iii)\tANGIOGRAPHY PACK, Model Number DYNJ67144A;  jjj)\tDRAINAGE PROCEDURE PACK, Model Number DYNJ67149A;  kkk)\tCARDIAC CATH PACK, Model Number DYNJ67174A;  lll)\tCARDIAC CATH PACK, Model Number DYNJ67174B;  mmm)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245A;  nnn)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245B;  ooo)\tANGIOGRAPHIC TRAY, Model Number DYNJ67320A;  ppp)\tIR PACK, Model Number DYNJ67737;  qqq)\tTUNNEL LINE PACK, Model Number DYNJ67990A;  rrr)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065B;  sss)\tNEURO RADIOLOGY RICHMOND, Model Number DYNJ68365B;  ttt)\tIR PACK, Model Number DYNJ68538;  uuu)\tSPECIAL PROCEDURE CATH LAB PK, Model Number DYNJ68729;  vvv)\tIR PACK, Model Number DYNJ68729B;  www)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763;  xxx)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763A;  yyy)\tIR RADIOLOGY PACK, Model Number DYNJ69056;  zzz)\tIR RADIOLOGY PACK, Model Number DYNJ69056A;  aaaa)\tANGIO PACK, Model Number DYNJ69200;  bbbb)\tHGH TAVI PACK, Model Number DYNJ69298;  cccc)\tANGIO TRAY, Model Number DYNJ69421;  dddd)\tENDOV",
      "product_quantity": "3,740,814 units in 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 DYNJ55252C, UDI/DI (EA)10195327267919, UDI/DI (CS)40195327267910;  b) Model Number DYNJ55455A, UDI/DI (EA)10193489386233, UDI/DI (CS)40193489386234;  c) Model Number DYNJ55680A, UDI/DI (EA)10889942639786, UDI/DI (CS)40889942639787;  d) Model Number DYNJ56038A, UDI/DI (EA)10195327347840, UDI/DI (CS)40195327347841;  e) Model Number DYNJ56547C, UDI/DI (EA)10193489879834, UDI/DI (CS)40193489879835;  f) Model Number DYNJ57049G, UDI/DI (EA)10195327110390, UDI/DI (CS)40195327110391;  g) Model Number DYNJ57049I, UDI/DI (EA)10195327207731, UDI/DI (CS)40195327207732;  h) Model Number DYNJ57049J, UDI/DI (EA)10195327290658, UDI/DI (CS)40195327290659;  i) Model Number DYNJ57645C, UDI/DI (EA)10195327287412, UDI/DI (CS)40195327287413;  j) Model Number DYNJ57760C, UDI/DI (EA)10195327079390, UDI/DI (CS)40195327079391;  k) Model Number DYNJ57792C, UDI/DI (EA)10195327209902, UDI/DI (CS)40195327209903;  l) Model Number DYNJ58111D, UDI/DI (EA)10193489932928, UDI/DI (CS)40193489932929;  m) Model Number DYNJ58111F, UDI/DI (EA)10195327223519, UDI/DI (CS)40195327223510;  n) Model Number DYNJ58162, UDI/DI (EA)10889942829330, UDI/DI (CS)40889942829331;  o) Model Number DYNJ58178B, UDI/DI (EA)10195327209919, UDI/DI (CS)40195327209910;  p) Model Number DYNJ58510A, UDI/DI (EA)10193489817430, UDI/DI (CS)40193489817431;  q) Model Number DYNJ59184B, UDI/DI (EA)10193489949100, UDI/DI (CS)40193489949101;  r) Model Number DYNJ59307F, UDI/DI (EA)10195327058852, UDI/DI (CS)40195327058853;  s) Model Number DYNJ59632D, UDI/DI (EA)10195327034078, UDI/DI (CS)40195327034079;  t) Model Number DYNJ60112B, UDI/DI (EA)10195327118846, UDI/DI (CS)40195327118847;  u) Model Number DYNJ60343B, UDI/DI (EA)10195327215491, UDI/DI (CS)40195327215492;  v) Model Number DYNJ60343C, UDI/DI (EA)10195327285043, UDI/DI (CS)40195327285044;  w) Model Number DYNJ60763, UDI/DI (EA)10193489527964, UDI/DI (CS)40193489527965;  x) Model Number DYNJ61082C, UDI/DI (EA)10195327111410, UDI/DI (CS)40195327111411;  y) Model Number DYNJ61082D, UDI/DI (EA)10195327261993, UDI/DI (CS)40195327261994;  z) Model Number DYNJ61099B, UDI/DI (EA)10195327111854, UDI/DI (CS)40195327111855;  aa) Model Number DYNJ61099C, UDI/DI (EA)10195327262006, UDI/DI (CS)40195327262007;  bb) Model Number DYNJ61118C, UDI/DI (EA)10193489463972, UDI/DI (CS)40193489463973;  cc) Model Number DYNJ61118D, UDI/DI (EA)10195327108212, UDI/DI (CS)40195327108213;  dd) Model Number DYNJ61118F, UDI/DI (EA)10195327261986, UDI/DI (CS)40195327261987;  ee) Model Number DYNJ61373A, UDI/DI (EA)10195327014698, UDI/DI (CS)40195327014699;  ff) Model Number DYNJ61527A, UDI/DI (EA)10195327383800, UDI/DI (CS)40195327383801;  gg) Model Number DYNJ61646A, UDI/DI (EA)10195327014315, UDI/DI (CS)40195327014316;  hh) Model Number DYNJ62007A, UDI/DI (EA)10193489878905, UDI/DI (CS)40193489878906;  ii) Model Number DYNJ62037D, UDI/DI (EA)10193489893694, UDI/DI (CS)40193489893695;  jj) Model Number DYNJ62733A, UDI/DI (EA)10193489970678, UDI/DI (CS)40193489970679;  kk) Model Number DYNJ63060B, UDI/DI (EA)10193489912821, UDI/DI (CS)40193489912822;  ll) Model Number DYNJ63181A, UDI/DI (EA)10195327045487, UDI/DI (CS)40195327045488;  mm) Model Number DYNJ63181B, UDI/DI (EA)10195327127213, UDI/DI (CS)40195327127214;  nn) Model Number DYNJ63181C, UDI/DI (EA)10195327242008, UDI/DI (CS)40195327242009;  oo) Model Number DYNJ64050A, UDI/DI (EA)10193489943825, UDI/DI (CS)40193489943826;  pp) Model Number DYNJ64655C, UDI/DI (EA)10195327172893, UDI/DI (CS)40195327172894;  qq) Model Number DYNJ64976, UDI/DI (EA)10193489237122, UDI/DI (CS)40193489237123;  rr) Model Number DYNJ65174D, UDI/DI (EA)10193489962154, UDI/DI (CS)40193489962155;  ss) Model Number DYNJ65190D, UDI/DI (EA)10195327066642, UDI/DI (CS)40195327066643;  tt) Model Number DYNJ65190F, UDI/DI (EA)10195327092658, UDI/DI (CS)40195327092659;  uu) Model Number DYNJ65481, UDI/DI (EA)10193489280463, UDI/DI (CS)40193489280464;  vv) Model Number DYNJ65913, UDI/DI (EA)10193489303179, UDI/DI (CS)40193489303170;  ww) Model Number DYNJ66166A, UDI/DI (EA)10193489395990, UDI/DI (CS)40193489395991;  xx) Model Number DYNJ66182, UDI/DI (EA)10193489320985, UDI/DI (CS)40193489320986;  yy) Model Number DYNJ66257, UDI/DI (EA)10193489325492, UDI/DI (CS)40193489325493;  zz) Model Number DYNJ66257A, UDI/DI (EA)10193489947502, UDI/DI (CS)40193489947503;  aaa) Model Number DYNJ66257B, UDI/DI (EA)10195327185831, UDI/DI (CS)40195327185832;  bbb) Model Number DYNJ66259A, UDI/DI (EA)10195327185732, UDI/DI (CS)40195327185733;  ccc) Model Number DYNJ66260A, UDI/DI (EA)10195327185749, UDI/DI (CS)40195327185740;  ddd) Model Number DYNJ66473A, UDI/DI (EA)10193489917772, UDI/DI (CS)40193489917773;  eee) Model Number DYNJ66476A, UDI/DI (EA)10195327051891, UDI/DI (CS)40195327051892;  fff) Model Number DYNJ66515A, UDI/DI (EA)10193489406160, UDI/DI (CS)40193489406161;  ggg) Model Number DYNJ66926A, UDI/DI (EA)10193489887358, UDI/DI (CS)40193489887359;  hhh) Model Number DYNJ67136A, UDI/DI (EA)10193489935677, UDI/DI (CS)40193489935678;  iii) Model Number DYNJ67144A, UDI/DI (EA)10195327179021, UDI/DI (CS)40195327179022;  jjj) Model Number DYNJ67149A, UDI/DI (EA)10195327179038, UDI/DI (CS)40195327179039;  kkk) Model Number DYNJ67174A, UDI/DI (EA)10195327046804, UDI/DI (CS)40195327046805;  lll) Model Number DYNJ67174B, UDI/DI (EA)10195327131081, UDI/DI (CS)40195327131082;  mmm) Model Number DYNJ67245A, UDI/DI (EA)10195327024253, UDI/DI (CS)40195327024254;  nnn) Model Number DYNJ67245B, UDI/DI (EA)10195327292225, UDI/DI (CS)40195327292226;  ooo) Model Number DYNJ67320A, UDI/DI (EA)10193489937572, UDI/DI (CS)40193489937573;  ppp) Model Number DYNJ67737, UDI/DI (EA)10193489427752, UDI/DI (CS)40193489427753;  qqq) Model Number DYNJ67990A, UDI/DI (EA)10195327265335, UDI/DI (CS)40195327265336;  rrr) Model Number DYNJ68065B, UDI/DI (EA)10195327013332, UDI/DI (CS)40195327013333;  sss) Model Number DYNJ68365B, UDI/DI (EA)10195327161934, UDI/DI (CS)40195327161935;  ttt) Model Number DYNJ68538, UDI/DI (EA)10193489833119, UDI/DI (CS)40193489833110;  uuu) Model Number DYNJ68729, UDI/DI (EA)10193489836547, UDI/DI (CS)40193489836548;  vvv) Model Number DYNJ68729B, UDI/DI (EA)10195327020910, UDI/DI (CS)40195327020911;  www) Model Number DYNJ68763, UDI/DI (EA)10193489837599, UDI/DI (CS)40193489837590;  xxx) Model Number DYNJ68763A, UDI/DI (EA)10195327264789, UDI/DI (CS)40195327264780;  yyy) Model Number DYNJ69056, UDI/DI (EA)10193489886870, UDI/DI (CS)40193489886871;  zzz) Model Number DYNJ69056A, UDI/DI (EA)10195327061296, UDI/DI (CS)40195327061297;  aaaa) Model Number DYNJ69200, UDI/DI (EA)10193489906813, UDI/DI (CS)40193489906814;  bbbb) Model Number DYNJ69298, UDI/DI (EA)10193489925418, UDI/DI (CS)40193489925419;  cccc) Model Number DYNJ69421, UDI/DI (EA)10193489937596, UDI/DI (CS)40193489937597;  dddd) Model Number DYNJ69691, UDI/DI (EA)10193489970111, UDI/DI (CS)40193489970112;  eeee) Model Number DYNJ69742B, UDI/DI (EA)10195327136888, UDI/DI (CS)40195327136889;  ffff) Model Number DYNJ69763A, UDI/DI (EA)10195327330019, UDI/DI (CS)40195327330010;  gggg) Model Number DYNJ69864, UDI/DI (EA)10193489990485, UDI/DI (CS)40193489990486;  hhhh) Model Number DYNJ69944, UDI/DI (EA)10193489998450, UDI/DI (CS)40193489998451;  iiii) Model Number DYNJ69944A, UDI/DI (EA)10195327285364, UDI/DI (CS)40195327285365;  jjjj) Model Number DYNJ69951, UDI/DI (EA)10195327000301, UDI/DI (CS)40195327000302;  kkkk) Model Number DYNJ80269, UDI/DI (EA)10195327017804, UDI/DI (CS)40195327017805;  llll) Model Number DYNJ80297, UDI/DI (EA)10195327021771, UDI/DI (CS)40195327021772;  mmmm) Model Number DYNJ80297A, UDI/DI (EA)10195327372170, UDI/DI (CS)40195327372171;  nnnn) Model Number DYNJ81213, UDI/DI (EA)10195327094270, UDI/DI (CS)40195327094271;  oooo) Model Number DYNJ81213A, UDI/DI (EA)10195327319250, UDI/DI (CS)40195327319251;  pppp) Model Number DYNJ81316, UDI/DI (EA)10195327103798, UDI/DI (CS)40195327103799;  qqqq) Model Number DYNJ81429A, UDI/DI (EA)10195327321642, UDI/DI (CS)40195327321643;  rrrr) Model Number DYNJ81435B, UDI/DI (EA)10195327324834, UDI/DI (CS)40195327324835;  ssss) Model Number DYNJ82030, UDI/DI (EA)10195327162375, UDI/DI (CS)40195327162376;  tttt) Model Number DYNJ82041, UDI/DI (EA)10195327162214, UDI/DI (CS)40195327162215;  uuuu) Model Number DYNJ82079, UDI/DI (EA)10195327167363, UDI/DI (CS)40195327167364;  vvvv) Model Number DYNJ82280, UDI/DI (EA)10195327183929, UDI/DI (CS)40195327183920;  wwww) Model Number DYNJ82296, UDI/DI (EA)10195327184209, UDI/DI (CS)40195327184200;  xxxx) Model Number DYNJ82999, UDI/DI (EA)10195327223106, UDI/DI (CS)40195327223107;  yyyy) Model Number DYNJ82999A, UDI/DI (EA)10195327310271, UDI/DI (CS)40195327310272;  zzzz)   Model Number DYNJ83089, UDI/DI (EA)10195327230838, UDI/DI (CS)40195327230839;",
      "more_code_info": ""
    }
  ]
}