{
  "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-2165-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tEP PACER PACK, Model Number DYNJ67770A;  b)\tEP PROCEDURE PACK, Model Number DYNJ67771;  c)\tEP PACK, Model Number DYNJ68019;  d)\tGWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198;  e)\tTAVR PACK, Model Number DYNJ68499B;  f)\tVEIN CLINIC, Model Number DYNJ68667;  g)\tVASCULAR PACK, Model Number DYNJ68863;  h)\tVASCULAR PACK, Model Number DYNJ68880;  i)\tTAVR PACK, Model Number DYNJ68933;  j)\tPROCEDURE PACK, Model Number DYNJ68968A;  k)\tPORT PACK, Model Number DYNJ68990A;  l)\tSTROKE PACK, Model Number DYNJ69009A;  m)\tENDOVENOUS BASIC PACK, Model Number DYNJ69108A;  n)\tVEIN ABLATION KIT, Model Number DYNJ69272A;  o)\tUPPER ENDOVASCULAR PK, Model Number DYNJ69302;  p)\tSTROKE PACK, Model Number DYNJ69422;  q)\tUNM PREHOSPITAL ECMO PACK, Model Number DYNJ69622;  r)\tUNM ACCESS PACK, Model Number DYNJ69624;  s)\tFLUSHING VASCULAR CENTER, Model Number DYNJ69626;  t)\tAFIB PACK, Model Number DYNJ69682;  u)\tENDOVASCULAR PACK, Model Number DYNJ69691A;  v)\tFISTULA SAVANNAH PACK, Model Number DYNJ69943A;  w)\tVEIN PACK, Model Number DYNJ80199A;  x)\tVEIN PACK, Model Number DYNJ80199B;  y)\tVASCULAR PACK, Model Number DYNJ80310;  z)\tCAROTID PACK, Model Number DYNJ80346A;  aa)\tENDOVENOUS ABLATION PACK, Model Number DYNJ80489;  bb)\tSTROKE KIT, Model Number DYNJ80506;  cc)\tVEIN PACK, Model Number DYNJ80868;  dd)\tVASCULAR ACCESS PACK, Model Number DYNJ81022;  ee)\tVASCULAR GENERAL PACK, Model Number DYNJ81023;  ff)\tAV FISTULA PACK, Model Number DYNJ81033;  gg)\tTAVR PACK, Model Number DYNJ81095;  hh)\tVASCULAR INSTITUTE OF KS PACK, Model Number DYNJ81200;  ii)\tVASCULAR INSTITUTE OF KS PACK, Model Number DYNJ81200A;  jj)\tLINQ PACK, Model Number DYNJ81320;  kk)\tEP DRAPE, Model Number DYNJ81462A;  ll)\tOR VASCULAR ANGIO PACK, Model Number DYNJ81592A;  mm)\tOR VASCULAR ANGIO PACK, Model Number DYNJ81592B;  nn)\tAV FISTULA PACK, Model Number DYNJ81605;  oo)\tMAJOR VASCULAR PACK, Model Number DYNJ81610;  pp)\tMAJOR VASCULAR PACK, Model Number DYNJ81610A;  qq)\tMAJOR VASCULAR PACK, Model Number DYNJ81610B;  rr)\tPROCEDURE PACK, Model Number DYNJ81618;  ss)\tVASCULAR PACK, Model Number DYNJ81626;  tt)\tVASCULAR PACK, Model Number DYNJ81626A;  uu)\tVASCULAR KIT, Model Number DYNJ81642;  vv)\tVASCULAR KIT, Model Number DYNJ81642A;  ww)\tUSGS PACK, Model Number DYNJ81705;  xx)\tEP PACK, Model Number DYNJ81716;  yy)\tEP PACK, Model Number DYNJ81716A;  zz)\tEP PACK, Model Number DYNJ81716B;  aaa)\tVASCULAR PACK, Model Number DYNJ82104;  bbb)\tVASCULAR AND INTERVENTION, Model Number DYNJ82109;  ccc)\tVASCULAR PACK, Model Number DYNJ82144;  ddd)\tSPECIALS MINOR RADIOLOGY PACK, Model Number DYNJ82314;  eee)\tTAVR PACK, Model Number DYNJ82372;  fff)\tFISTULA PACK, Model Number DYNJ82711;  ggg)\tIR ANGIOGRAM LIGHT PK, Model Number DYNJ82858A;  hhh)\tIR ANGIOGRAM PACK, Model Number DYNJ82859A;  iii)\tMARGIN SIMPLE VEIN PACK, Model Number DYNJ82987;  jjj)\tMARGIN FULL VEIN PACK, Model Number DYNJ82988;  kkk)\tMARGIN FULL VEIN PACK, Model Number DYNJ82988A;  lll)\tARTERIOGRAM PACK 2, Model Number DYNJ83051;  mmm)\tVASCULAR PACK, Model Number DYNJ83146;  nnn)\tVEIN PACK, Model Number DYNJ83147;  ooo)\tENDOVASCULAR PACK, Model Number DYNJ83161;  ppp)\tCVOR ANGIOGRAPHY PACK, Model Number DYNJ83432;  qqq)\tVIRC STROKE PACK, Model Number DYNJ83461;  rrr)\tRADIO VEIN ABLATION PACK, Model Number DYNJ83490;  sss)\tENDOVENOUS PACK, Model Number DYNJ83606;  ttt)\tENDO VASCULAR PACK, Model Number DYNJ83624;  uuu)\tENDOVASCULAR PACK, Model Number DYNJ83972;  vvv)\tTEMP PERM KIT, Model Number DYNJ84130;  www)\tVASCULAR PACK, Model Number DYNJ84252;  xxx)\tOPEN HEART PART 2, Model Number DYNJ901075O;  yyy)\tOPEN HEART PART 2, Model Number DYNJ901075P;  zzz)\tCAROTID-LF, Model Number DYNJ901745K;  aaaa)\tVASCULAR ANGIO, Model Number DYNJ902259B;  bbbb)\tVASCULAR CUT DOWN, Model Number DYNJ902261G;  cccc)\tVASCULAR, Model Number DYNJ902704P;  dddd)\tENDOVASCULAR, Model Number DYNJ903451D;  eeee)\tTICKER FIXER2, Model Number DYNJ903919J;  ffff)\tTICK",
      "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 Numbers DYNJ67770A, UDI/DI (EA)10195327290979, UDI/DI (CS)40195327290970;  b) Model Numbers DYNJ67771, UDI/DI (EA)10193489430721, UDI/DI (CS)40193489430722;  c) Model Numbers DYNJ68019, UDI/DI (EA)10193489467840, UDI/DI (CS)40193489467841;  d) Model Numbers DYNJ68198, UDI/DI (EA)10193489499179, UDI/DI (CS)40193489499170;  e) Model Numbers DYNJ68499B, UDI/DI (EA)10195327034054, UDI/DI (CS)40195327034055;  f) Model Numbers DYNJ68667, UDI/DI (EA)10193489837315, UDI/DI (CS)40193489837316;  g) Model Numbers DYNJ68863, UDI/DI (EA)10193489845402, UDI/DI (CS)40193489845403;  h) Model Numbers DYNJ68880, UDI/DI (EA)10193489847727, UDI/DI (CS)40193489847728;  i) Model Numbers DYNJ68933, UDI/DI (EA)10193489860375, UDI/DI (CS)40193489860376;  j) Model Numbers DYNJ68968A, UDI/DI (EA)10195327206840, UDI/DI (CS)40195327206841;  k) Model Numbers DYNJ68990A, UDI/DI (EA)10193489981360, UDI/DI (CS)40193489981361;  l) Model Numbers DYNJ69009A, UDI/DI (EA)10195327075569, UDI/DI (CS)40195327075560;  m) Model Numbers DYNJ69108A, UDI/DI (EA)10195327025717, UDI/DI (CS)40195327025718;  n) Model Numbers DYNJ69272A, UDI/DI (EA)10195327015800, UDI/DI (CS)40195327015801;  o) Model Numbers DYNJ69302, UDI/DI (EA)10193489926279, UDI/DI (CS)40193489926270;  p) Model Numbers DYNJ69422, UDI/DI (EA)10193489937541, UDI/DI (CS)40193489937542;  q) Model Numbers DYNJ69622, UDI/DI (EA)10193489959581, UDI/DI (CS)40193489959582;  r) Model Numbers DYNJ69624, UDI/DI (EA)10193489959567, UDI/DI (CS)40193489959568;  s) Model Numbers DYNJ69626, UDI/DI (EA)10193489960693, UDI/DI (CS)40193489960694;  t) Model Numbers DYNJ69682, UDI/DI (EA)10193489968927, UDI/DI (CS)40193489968928;  u) Model Numbers DYNJ69691A, UDI/DI (EA)10195327070267, UDI/DI (CS)40195327070268;  v) Model Numbers DYNJ69943A, UDI/DI (EA)10195327284633, UDI/DI (CS)40195327284634;  w) Model Numbers DYNJ80199A, UDI/DI (EA)10195327040864, UDI/DI (CS)40195327040865;  x) Model Numbers DYNJ80199B, UDI/DI (EA)10195327088200, UDI/DI (CS)40195327088201;  y) Model Numbers DYNJ80310, UDI/DI (EA)10195327023201, UDI/DI (CS)40195327023202;  z) Model Numbers DYNJ80346A, UDI/DI (EA)10195327166250, UDI/DI (CS)40195327166251;  aa) Model Numbers DYNJ80489, UDI/DI (EA)10195327045845, UDI/DI (CS)40195327045846;  bb) Model Numbers DYNJ80506, UDI/DI (EA)10195327049171, UDI/DI (CS)40195327049172;  cc) Model Numbers DYNJ80868, UDI/DI (EA)10195327082505, UDI/DI (CS)40195327082506;  dd) Model Numbers DYNJ81022, UDI/DI (EA)10195327082789, UDI/DI (CS)40195327082780;  ee) Model Numbers DYNJ81023, UDI/DI (EA)10195327082796, UDI/DI (CS)40195327082797;  ff) Model Numbers DYNJ81033, UDI/DI (EA)10195327082987, UDI/DI (CS)40195327082988;  gg) Model Numbers DYNJ81095, UDI/DI (EA)10195327084127, UDI/DI (CS)40195327084128;  hh) Model Numbers DYNJ81200, UDI/DI (EA)10195327091699, UDI/DI (CS)40195327091690;  ii) Model Numbers DYNJ81200A, UDI/DI (EA)10195327224714, UDI/DI (CS)40195327224715;  jj) Model Numbers DYNJ81320, UDI/DI (EA)10195327110147, UDI/DI (CS)40195327110148;  kk) Model Numbers DYNJ81462A, UDI/DI (EA)10195327378615, UDI/DI (CS)40195327378616;  ll) Model Numbers DYNJ81592A, UDI/DI (EA)10195327315054, UDI/DI (CS)40195327315055;  mm) Model Numbers DYNJ81592B, UDI/DI (EA)10195327398309, UDI/DI (CS)40195327398300;  nn) Model Numbers DYNJ81605, UDI/DI (EA)10195327123888, UDI/DI (CS)40195327123889;  oo) Model Numbers DYNJ81610, UDI/DI (EA)10195327123949, UDI/DI (CS)40195327123940;  pp) Model Numbers DYNJ81610A, UDI/DI (EA)10195327315047, UDI/DI (CS)40195327315048;  qq) Model Numbers DYNJ81610B, UDI/DI (EA)10195327398316, UDI/DI (CS)40195327398317;  rr) Model Numbers DYNJ81618, UDI/DI (EA)10195327124601, UDI/DI (CS)40195327124602;  ss) Model Numbers DYNJ81626, UDI/DI (EA)10195327127060, UDI/DI (CS)40195327127061;  tt) Model Numbers DYNJ81626A, UDI/DI (EA)10195327297190, UDI/DI (CS)40195327297191;  uu) Model Numbers DYNJ81642, UDI/DI (EA)10195327129668, UDI/DI (CS)40195327129669;  vv) Model Numbers DYNJ81642A, UDI/DI (EA)10195327266387, UDI/DI (CS)40195327266388;  ww) Model Numbers DYNJ81705, UDI/DI (EA)10195327135577, UDI/DI (CS)40195327135578;  xx) Model Numbers DYNJ81716, UDI/DI (EA)10195327138066, UDI/DI (CS)40195327138067;  yy) Model Numbers DYNJ81716A, UDI/DI (EA)10195327203856, UDI/DI (CS)40195327203857;  zz) Model Numbers DYNJ81716B, UDI/DI (EA)10195327277260, UDI/DI (CS)40195327277261;  aaa) Model Numbers DYNJ82104, UDI/DI (EA)10195327171087, UDI/DI (CS)40195327171088;  bbb) Model Numbers DYNJ82109, UDI/DI (EA)10195327171247, UDI/DI (CS)40195327171248;  ccc) Model Numbers DYNJ82144, UDI/DI (EA)10195327178031, UDI/DI (CS)40195327178032;  ddd) Model Numbers DYNJ82314, UDI/DI (EA)10195327184216, UDI/DI (CS)40195327184217;  eee) Model Numbers DYNJ82372, UDI/DI (EA)10195327187538, UDI/DI (CS)40195327187539;  fff) Model Numbers DYNJ82711, UDI/DI (EA)10195327203627, UDI/DI (CS)40195327203628;  ggg) Model Numbers DYNJ82858A, UDI/DI (EA)10195327244897, UDI/DI (CS)40195327244898;  hhh) Model Numbers DYNJ82859A, UDI/DI (EA)10195327244903, UDI/DI (CS)40195327244904;  iii) Model Numbers DYNJ82987, UDI/DI (EA)10195327222116, UDI/DI (CS)40195327222117;  jjj) Model Numbers DYNJ82988, UDI/DI (EA)10195327222208, UDI/DI (CS)40195327222209;  kkk) Model Numbers DYNJ82988A, UDI/DI (EA)10195327293314, UDI/DI (CS)40195327293315;  lll) Model Numbers DYNJ83051, UDI/DI (EA)10195327245283, UDI/DI (CS)40195327245284;  mmm) Model Numbers DYNJ83146, UDI/DI (EA)10195327235680, UDI/DI (CS)40195327235681;  nnn) Model Numbers DYNJ83147, UDI/DI (EA)10195327235505, UDI/DI (CS)40195327235506;  ooo) Model Numbers DYNJ83161, UDI/DI (EA)10195327237837, UDI/DI (CS)40195327237838;  ppp) Model Numbers DYNJ83432, UDI/DI (EA)10195327266530, UDI/DI (CS)40195327266531;  qqq) Model Numbers DYNJ83461, UDI/DI (EA)10195327267797, UDI/DI (CS)40195327267798;  rrr) Model Numbers DYNJ83490, UDI/DI (EA)10195327271411, UDI/DI (CS)40195327271412;  sss) Model Numbers DYNJ83606, UDI/DI (EA)10195327284855, UDI/DI (CS)40195327284856;  ttt) Model Numbers DYNJ83624, UDI/DI (EA)10195327285869, UDI/DI (CS)40195327285860;  uuu) Model Numbers DYNJ83972, UDI/DI (EA)10195327322694, UDI/DI (CS)40195327322695;  vvv) Model Numbers DYNJ84130, UDI/DI (EA)10195327334550, UDI/DI (CS)40195327334551;  www) Model Numbers DYNJ84252, UDI/DI (EA)10195327345570, UDI/DI (CS)40195327345571;  xxx) Model Numbers DYNJ901075O, UDI/DI (EA)10195327052683, UDI/DI (CS)40195327052684;  yyy) Model Numbers DYNJ901075P, UDI/DI (EA)10195327253554, UDI/DI (CS)40195327253555;  zzz) Model Numbers DYNJ901745K, UDI/DI (EA)10193489482232, UDI/DI (CS)40193489482233;  aaaa) Model Numbers DYNJ902259B, UDI/DI (EA)10193489919714, UDI/DI (CS)40193489919715;  bbbb) Model Numbers DYNJ902261G, UDI/DI (EA)10193489919721, UDI/DI (CS)40193489919722;  cccc) Model Numbers DYNJ902704P, UDI/DI (EA)10193489863376, UDI/DI (CS)40193489863377;  dddd) Model Numbers DYNJ903451D, UDI/DI (EA)10193489667851, UDI/DI (CS)40193489667852;  eeee) Model Numbers DYNJ903919J, UDI/DI (EA)10195327045906, UDI/DI (CS)40195327045907;  ffff) Model Numbers DYNJ903919K, UDI/DI (EA)10195327218782, UDI/DI (CS)40195327218783;  gggg) Model Numbers DYNJ903919L, UDI/DI (EA)10195327267056, UDI/DI (CS)40195327267057;  hhhh) Model Numbers DYNJ904171F, UDI/DI (EA)10193489439243, UDI/DI (CS)40193489439244;  iiii) Model Numbers DYNJ904401C, UDI/DI (EA)10193489348910, UDI/DI (CS)40193489348911;  jjjj) Model Numbers DYNJ904984B, UDI/DI (EA)10193489812930, UDI/DI (CS)40193489812931;  kkkk) Model Numbers DYNJ905079F, UDI/DI (EA)10195327209001, UDI/DI (CS)40195327209002;  llll) Model Numbers DYNJ905285C, UDI/DI (EA)10193489947250, UDI/DI (CS)40193489947251;  mmmm) Model Numbers DYNJ905291B, UDI/DI (EA)10193489950373, UDI/DI (CS)40193489950374;  nnnn) Model Numbers DYNJ905291C, UDI/DI (EA)10195327062545, UDI/DI (CS)40195327062546;  oooo) Model Numbers DYNJ905311I, UDI/DI (EA)10195327146214, UDI/DI (CS)40195327146215;  pppp) Model Numbers DYNJ905516C, UDI/DI (EA)10193489967128, UDI/DI (CS)40193489967129;  qqqq) Model Numbers DYNJ905516D, UDI/DI (EA)10195327147839, UDI/DI (CS)40195327147830;  rrrr) Model Numbers DYNJ905516F, UDI/DI (EA)10195327247577, UDI/DI (CS)40195327247578;  ssss) Model Numbers DYNJ905726C, UDI/DI (EA)10193489943375, UDI/DI (CS)40193489943376;  tttt) Model Numbers DYNJ905726D, UDI/DI (EA)10195327161514, UDI/DI (CS)40195327161515;  uuuu) Model Numbers DYNJ905744C, UDI/DI (EA)10195327162313, UDI/DI (CS)40195327162314;  vvvv) Model Numbers DYNJ905859B, UDI/DI (EA)10193489417869, UDI/DI (CS)40193489417860;  wwww) Model Numbers DYNJ905884A, UDI/DI (EA)10193489795448, UDI/DI (CS)40193489795449;  xxxx) Model Numbers DYNJ906086B, UDI/DI (EA)10195327046354, UDI/DI (CS)40195327046355;  yyyy) Model Numbers DYNJ906098A, UDI/DI (EA)10193489209457, UDI/DI (CS)40193489209458;  zzzz) Model Numbers DYNJ906102F, UDI/DI (EA)10195327028268, UDI/DI (CS)40195327028269;",
      "more_code_info": ""
    }
  ]
}