{
  "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-2164-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tMHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K;  b)\tVEIN SPECIALISTS PACK, Model Number DYNJ53616A;  c)\tSUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B;  d)\tVEIN PACK, Model Number DYNJ54153B;  e)\tRFD-ENDOVASCULAR OR PACK, Model Number DYNJ54265A;  f)\tPEDI EP PACK, Model Number DYNJ54750G;  g)\tEL PASO VERICOSE VEIN PACK, Model Number DYNJ54803C;  h)\tLEE VEIN PACK, Model Number DYNJ54906B;  i)\tHEART FAILURE PK, Model Number DYNJ55528A;  j)\tHEART FAILURE PK, Model Number DYNJ55528B;  k)\tHEART FAILURE PK, Model Number DYNJ55528C;  l)\tROCKWAY VASCULAR PACK-LF, Model Number DYNJ55757C;  m)\tOPEN HEART ANGIO PACK, Model Number DYNJ55836B;  n)\tDR NACKMAN VEIN PACK, Model Number DYNJ56235;  o)\tKT TAVR PACK, Model Number DYNJ56283D;  p)\tKT TAVR PACK, Model Number DYNJ56283F;  q)\tVEIN PACK, Model Number DYNJ56724B;  r)\tVASCULAR PACK, Model Number DYNJ56791A;  s)\tVASCULAR PACK, Model Number DYNJ56791B;  t)\tECMO PACK, Model Number DYNJ56904;  u)\tVEIN KIT, Model Number DYNJ57047;  v)\tEH TAVR PACK, Model Number DYNJ57449F;  w)\tEH TAVR PACK, Model Number DYNJ57449G;  x)\tVASCULAR PACK, Model Number DYNJ57490A;  y)\tVEIN PACK, Model Number DYNJ57512;  z)\tDEVICE PACK, Model Number DYNJ57595A;  aa)\tCAROTID PACK-LF, Model Number DYNJ57646B;  bb)\tCAROTID PACK-LF, Model Number DYNJ57646C;  cc)\tCATH LAB PACK, Model Number DYNJ57735F;  dd)\tVEIN PACK, Model Number DYNJ57835;  ee)\tVEIN PACK, Model Number DYNJ57917;  ff)\tENS. THROMBOLYSE/EMBOLISAT-LF, Model Number DYNJ58179C;  gg)\tHEART VALVE PACK, Model Number DYNJ58365J;  hh)\tVEIN PACK, Model Number DYNJ58609;  ii)\tVASCULAR PACK, Model Number DYNJ58681A;  jj)\tVASCULAR PACK, Model Number DYNJ58681B;  kk)\tVASCULAR PACK, Model Number DYNJ58710;  ll)\tDR HARRISON VEIN PACK II, Model Number DYNJ59028A;  mm)\tVEIN PACK, Model Number DYNJ59151F;  nn)\tEP LAB, Model Number DYNJ59392D;  oo)\tEP LAB, Model Number DYNJ59392F;  pp)\tVEIN PACK, Model Number DYNJ59662D;  qq)\tVEIN PACK, Model Number DYNJ59681A;  rr)\tVASCULAR PACK CHRG, Model Number DYNJ59778B;  ss)\tVASCULAR ACCESS KIT, Model Number DYNJ59796C;  tt)\tCATH PACK, Model Number DYNJ59830A;  uu)\tVENOUS ACCESS ACCESSORY PACK, Model Number DYNJ61010A;  vv)\tDR SIRAGUSA VEIN PACK, Model Number DYNJ61247;  ww)\tMAIN OR CATH LAB, Model Number DYNJ61373;  xx)\tVASCULAR PACK, Model Number DYNJ61528;  yy)\tVASCULAR PACK, Model Number DYNJ61528A;  zz)\tVEIN PACK, Model Number DYNJ61540C;  aaa)\tNEURO VASCULAR PACK, Model Number DYNJ61584A;  bbb)\tABLATION PACK, Model Number DYNJ61957A;  ccc)\tHEART GROIN PACK, Model Number DYNJ61981C;  ddd)\tPERMA CATH PACK, Model Number DYNJ62007B;  eee)\tPURPLE PACK, Model Number DYNJ62197A;  fff)\tPURPLE PACK, Model Number DYNJ62197B;  ggg)\tCLOVIS CATH LAB PACK, Model Number DYNJ62379A;  hhh)\tVASCULAR PACK, Model Number DYNJ62399A;  iii)\tNORTH TEXAS VASCULAR, Model Number DYNJ62735;  jjj)\tVEIN TRAY, Model Number DYNJ62829A;  kkk)\tHEART VEIN NYC LASER ABLATION, Model Number DYNJ62850A;  lll)\tHEART VEIN NYC -ARTERIAL PACK, Model Number DYNJ62851B;  mmm)\tTAVR PACK, Model Number DYNJ62915B;  nnn)\tPACER SET UP PACK, Model Number DYNJ63069A;  ooo)\tOPEN HEART TAVR PACK, Model Number DYNJ63099D;  ppp)\tOPEN HEART TAVR PACK, Model Number DYNJ63099F;  qqq)\tELECTROPHYSIOLOGY PACK, Model Number DYNJ63209;  rrr)\tTAVR PACK, Model Number DYNJ63340A;  sss)\tVEIN PACK, Model Number DYNJ63823;  ttt)\tNIR PACK, Model Number DYNJ63892A;  uuu)\tVEIN ABLATION TRAY W/CHLOR, Model Number DYNJ64396;  vvv)\tTORRES-VEIN PACK, Model Number DYNJ64449;  www)\tVEIN PACK, Model Number DYNJ64471A;  xxx)\tCVOR ENDOVASCULAR PACK, Model Number DYNJ64506A;  yyy)\tHEART FAILURE  PACK, Model Number DYNJ64877B;  zzz)\tCT ABLATION PACK, Model Number DYNJ64928;  aaaa)\tVEIN PROCEDURE, Model Number DYNJ65342A;  bbbb)\tSMALL TRAY VASCULAR PACK, Model Number DYNJ65418;  cccc)\tVEIN OHH, Model Number DYNJ65560A;  dddd)\tPORT PICC TUNNEL PACK, Model Number DYNJ65775A;  eeee)\tVARITHENA PACK, Model Number DYNJ65",
      "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 DYNJ53433K, UDI/DI (EA)10195327339487, UDI/DI (CS)40195327339488;  b) Model Numbers DYNJ53616A, UDI/DI (EA)10889942688562, UDI/DI (CS)40889942688563;  c) Model Numbers DYNJ54014B, UDI/DI (EA)10889942760329, UDI/DI (CS)40889942760320;  d) Model Numbers DYNJ54153B, UDI/DI (EA)10889942714421, UDI/DI (CS)40889942714422;  e) Model Numbers DYNJ54265A, UDI/DI (EA)10195327152338, UDI/DI (CS)40195327152339;  f) Model Numbers DYNJ54750G, UDI/DI (EA)10195327021351, UDI/DI (CS)40195327021352;  g) Model Numbers DYNJ54803C, UDI/DI (EA)10193489202618, UDI/DI (CS)40193489202619;  h) Model Numbers DYNJ54906B, UDI/DI (EA)10193489289633, UDI/DI (CS)40193489289634;  i) Model Numbers DYNJ55528A, UDI/DI (EA)10889942976638, UDI/DI (CS)40889942976639;  j) Model Numbers DYNJ55528B, UDI/DI (EA)10195327046491, UDI/DI (CS)40195327046492;  k) Model Numbers DYNJ55528C, UDI/DI (EA)10195327248208, UDI/DI (CS)40195327248209;  l) Model Numbers DYNJ55757C, UDI/DI (EA)10195327116538, UDI/DI (CS)40195327116539;  m) Model Numbers DYNJ55836B, UDI/DI (EA)10193489951172, UDI/DI (CS)40193489951173;  n) Model Numbers DYNJ56235, UDI/DI (EA)10889942621552, UDI/DI (CS)40889942621553;  o) Model Numbers DYNJ56283D, UDI/DI (EA)10195327093877, UDI/DI (CS)40195327093878;  p) Model Numbers DYNJ56283F, UDI/DI (EA)10195327211851, UDI/DI (CS)40195327211852;  q) Model Numbers DYNJ56724B, UDI/DI (EA)10193489466317, UDI/DI (CS)40193489466318;  r) Model Numbers DYNJ56791A, UDI/DI (EA)10193489594119, UDI/DI (CS)40193489594110;  s) Model Numbers DYNJ56791B, UDI/DI (EA)10195327045678, UDI/DI (CS)40195327045679;  t) Model Numbers DYNJ56904, UDI/DI (EA)10889942693450, UDI/DI (CS)40889942693451;  u) Model Numbers DYNJ57047, UDI/DI (EA)10889942710485, UDI/DI (CS)40889942710486;  v) Model Numbers DYNJ57449F, UDI/DI (EA)10193489939200, UDI/DI (CS)40193489939201;  w) Model Numbers DYNJ57449G, UDI/DI (EA)10195327064884, UDI/DI (CS)40195327064885;  x) Model Numbers DYNJ57490A, UDI/DI (EA)10193489641998, UDI/DI (CS)40193489641999;  y) Model Numbers DYNJ57512, UDI/DI (EA)10889942748273, UDI/DI (CS)40889942748274;  z) Model Numbers DYNJ57595A, UDI/DI (EA)10193489622157, UDI/DI (CS)40193489622158;  aa) Model Numbers DYNJ57646B, UDI/DI (EA)10193489828504, UDI/DI (CS)40193489828505;  bb) Model Numbers DYNJ57646C, UDI/DI (EA)10195327287139, UDI/DI (CS)40195327287130;  cc) Model Numbers DYNJ57735F, UDI/DI (EA)10193489629705, UDI/DI (CS)40193489629706;  dd) Model Numbers DYNJ57835, UDI/DI (EA)10889942782338, UDI/DI (CS)40889942782339;  ee) Model Numbers DYNJ57917, UDI/DI (EA)10889942794294, UDI/DI (CS)40889942794295;  ff) Model Numbers DYNJ58179C, UDI/DI (EA)10195327209926, UDI/DI (CS)40195327209927;  gg) Model Numbers DYNJ58365J, UDI/DI (EA)10195327019099, UDI/DI (CS)40195327019090;  hh) Model Numbers DYNJ58609, UDI/DI (EA)10889942871261, UDI/DI (CS)40889942871262;  ii) Model Numbers DYNJ58681A, UDI/DI (EA)10888277798489, UDI/DI (CS)40888277798480;  jj) Model Numbers DYNJ58681B, UDI/DI (EA)10195327293376, UDI/DI (CS)40195327293377;  kk) Model Numbers DYNJ58710, UDI/DI (EA)10889942880850, UDI/DI (CS)40889942880851;  ll) Model Numbers DYNJ59028A, UDI/DI (EA)10193489736595, UDI/DI (CS)40193489736596;  mm) Model Numbers DYNJ59151F, UDI/DI (EA)10193489487565, UDI/DI (CS)40193489487566;  nn) Model Numbers DYNJ59392D, UDI/DI (EA)10195327053574, UDI/DI (CS)40195327053575;  oo) Model Numbers DYNJ59392F, UDI/DI (EA)10195327135980, UDI/DI (CS)40195327135981;  pp) Model Numbers DYNJ59662D, UDI/DI (EA)10195327030872, UDI/DI (CS)40195327030873;  qq) Model Numbers DYNJ59681A, UDI/DI (EA)10193489469875, UDI/DI (CS)40193489469876;  rr) Model Numbers DYNJ59778B, UDI/DI (EA)10193489695922, UDI/DI (CS)40193489695923;  ss) Model Numbers DYNJ59796C, UDI/DI (EA)10193489904215, UDI/DI (CS)40193489904216;  tt) Model Numbers DYNJ59830A, UDI/DI (EA)10193489570236, UDI/DI (CS)40193489570237;  uu) Model Numbers DYNJ61010A, UDI/DI (EA)10193489307146, UDI/DI (CS)40193489307147;  vv) Model Numbers DYNJ61247, UDI/DI (EA)10193489551709, UDI/DI (CS)40193489551700;  ww) Model Numbers DYNJ61373, UDI/DI (EA)10193489576696, UDI/DI (CS)40193489576697;  xx) Model Numbers DYNJ61528, UDI/DI (EA)10193489578980, UDI/DI (CS)40193489578981;  yy) Model Numbers DYNJ61528A, UDI/DI (EA)10195327336714, UDI/DI (CS)40195327336715;  zz) Model Numbers DYNJ61540C, UDI/DI (EA)10193489495126, UDI/DI (CS)40193489495127;  aaa) Model Numbers DYNJ61584A, UDI/DI (EA)10193489812817, UDI/DI (CS)40193489812818;  bbb) Model Numbers DYNJ61957A, UDI/DI (EA)10193489699074, UDI/DI (CS)40193489699075;  ccc) Model Numbers DYNJ61981C, UDI/DI (EA)10195327106027, UDI/DI (CS)40195327106028;  ddd) Model Numbers DYNJ62007B, UDI/DI (EA)10195327161965, UDI/DI (CS)40195327161966;  eee) Model Numbers DYNJ62197A, UDI/DI (EA)10193489994094, UDI/DI (CS)40193489994095;  fff) Model Numbers DYNJ62197B, UDI/DI (EA)10195327167240, UDI/DI (CS)40195327167241;  ggg) Model Numbers DYNJ62379A, UDI/DI (EA)10195327196639, UDI/DI (CS)40195327196630;  hhh) Model Numbers DYNJ62399A, UDI/DI (EA)10193489250268, UDI/DI (CS)40193489250269;  iii) Model Numbers DYNJ62735, UDI/DI (EA)10193489685282, UDI/DI (CS)40193489685283;  jjj) Model Numbers DYNJ62829A, UDI/DI (EA)10193489306620, UDI/DI (CS)40193489306621;  kkk) Model Numbers DYNJ62850A, UDI/DI (EA)10193489784237, UDI/DI (CS)40193489784238;  lll) Model Numbers DYNJ62851B, UDI/DI (EA)10193489271218, UDI/DI (CS)40193489271219;  mmm) Model Numbers DYNJ62915B, UDI/DI (EA)10193489365351, UDI/DI (CS)40193489365352;  nnn) Model Numbers DYNJ63069A, UDI/DI (EA)10193489423617, UDI/DI (CS)40193489423618;  ooo) Model Numbers DYNJ63099D, UDI/DI (EA)10193489932690, UDI/DI (CS)40193489932691;  ppp) Model Numbers DYNJ63099F, UDI/DI (EA)10195327150037, UDI/DI (CS)40195327150038;  qqq) Model Numbers DYNJ63209, UDI/DI (EA)10193489727883, UDI/DI (CS)40193489727884;  rrr) Model Numbers DYNJ63340A, UDI/DI (EA)10195327273583, UDI/DI (CS)40195327273584;  sss) Model Numbers DYNJ63823, UDI/DI (EA)10193489763423, UDI/DI (CS)40193489763424;  ttt) Model Numbers DYNJ63892A, UDI/DI (EA)10195327176518, UDI/DI (CS)40195327176519;  uuu) Model Numbers DYNJ64396, UDI/DI (EA)10193489810509, UDI/DI (CS)40193489810500;  vvv) Model Numbers DYNJ64449, UDI/DI (EA)10193489201574, UDI/DI (CS)40193489201575;  www) Model Numbers DYNJ64471A, UDI/DI (EA)10193489414158, UDI/DI (CS)40193489414159;  xxx) Model Numbers DYNJ64506A, UDI/DI (EA)10193489971064, UDI/DI (CS)40193489971065;  yyy) Model Numbers DYNJ64877B, UDI/DI (EA)10193489415896, UDI/DI (CS)40193489415897;  zzz) Model Numbers DYNJ64928, UDI/DI (EA)10193489231502, UDI/DI (CS)40193489231503;  aaaa) Model Numbers DYNJ65342A, UDI/DI (EA)10193489369663, UDI/DI (CS)40193489369664;  bbbb) Model Numbers DYNJ65418, UDI/DI (EA)10193489273717, UDI/DI (CS)40193489273718;  cccc) Model Numbers DYNJ65560A, UDI/DI (EA)10193489397185, UDI/DI (CS)40193489397186;  dddd) Model Numbers DYNJ65775A, UDI/DI (EA)10195327140229, UDI/DI (CS)40195327140220;  eeee) Model Numbers DYNJ65842, UDI/DI (EA)10193489296310, UDI/DI (CS)40193489296311;  ffff) Model Numbers DYNJ66076, UDI/DI (EA)10193489319231, UDI/DI (CS)40193489319232;  gggg) Model Numbers DYNJ66152A, UDI/DI (EA)10193489820218, UDI/DI (CS)40193489820219;  hhhh) Model Numbers DYNJ66152B, UDI/DI (EA)10195327090425, UDI/DI (CS)40195327090426;  iiii) Model Numbers DYNJ66271C, UDI/DI (EA)10195327098506, UDI/DI (CS)40195327098507;  jjjj) Model Numbers DYNJ66356C, UDI/DI (EA)10193489991055, UDI/DI (CS)40193489991056;  kkkk) Model Numbers DYNJ66356D, UDI/DI (EA)10195327060299, UDI/DI (CS)40195327060290;  llll) Model Numbers DYNJ66356G, UDI/DI (EA)10195327357306, UDI/DI (CS)40195327357307;  mmmm) Model Numbers DYNJ66427, UDI/DI (EA)10193489354683, UDI/DI (CS)40193489354684;  nnnn) Model Numbers DYNJ66445, UDI/DI (EA)10193489356083, UDI/DI (CS)40193489356084;  oooo) Model Numbers DYNJ66743A, UDI/DI (EA)10193489435559, UDI/DI (CS)40193489435550;  pppp) Model Numbers DYNJ66769, UDI/DI (EA)10193489380521, UDI/DI (CS)40193489380522;  qqqq) Model Numbers DYNJ66916A, UDI/DI (EA)10193489993226, UDI/DI (CS)40193489993227;  rrrr) Model Numbers DYNJ66926B, UDI/DI (EA)10195327340261, UDI/DI (CS)40195327340262;  ssss) Model Numbers DYNJ67487B, UDI/DI (EA)10195327166144, UDI/DI (CS)40195327166145;  tttt) Model Numbers DYNJ67487C, UDI/DI (EA)10195327260743, UDI/DI (CS)40195327260744;  uuuu) Model Numbers DYNJ67517A, UDI/DI (EA)10193489462197, UDI/DI (CS)40193489462198;  vvvv) Model Numbers DYNJ67725, UDI/DI (EA)10193489425840, UDI/DI (CS)40193489425841;  wwww) Model Numbers DYNJ67750A, UDI/DI (EA)10193489832242, UDI/DI (CS)40193489832243;  xxxx) Model Numbers DYNJ67750B, UDI/DI (EA)10193489912043, UDI/DI (CS)40193489912044;  yyyy) Model Numbers DYNJ67750C, UDI/DI (EA)10195327341367, UDI/DI (CS)40195327341368;  zzzz) Model Numbers DYNJ67770, UDI/DI (EA)10193489430714, UDI/DI (CS)40193489430715;",
      "more_code_info": ""
    }
  ]
}