{
  "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-2163-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a.\tNORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q;  b.\tPERCUTANEOUS VASCULAR CDS, Model Number CDS840487I;  c.\tBAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I;  d.\tENDOVASCULAR CDS, Model Number CDS983394I;  e.\tENDOVASCULAR CDS, Model Number CDS983394J;  f.\tENDOVASCULAR CDS, Model Number CDS983394K;  g.\tOPEN HEART CDS, Model Number CDS983513F;  h.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849D;  i.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849F;  j.\tVNUS, Model Number CDS984292I;  k.\tOPEN HEART CDS, Model Number CDS984355G;  l.\tBEDSIDE PICC CDS, Model Number CDS984642;  m.\tVASCULAR, Model Number CDS984764G;  n.\tOPEN HEART A, Model Number CDS985105O;  o.\tVASCULAR, Model Number CDS985355D;  p.\tVASCULAR, Model Number CDS985355F;  q.\tECMO KIT, Model Number CVI4955;  r.\tKIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21;  s.\tVASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526;  t.\tARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038;  u.\tDIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B;  v.\tOPEN HEART CABG PACK-LF, Model Number DYNJ0149567C;  w.\tVASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ;  x.\tOPEN HEART PACK-LF, Model Number DYNJ0371669N;  y.\tCABG PACK, Model Number DYNJ0408782AA;  z.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185K;  aa.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185M;  bb.\tOPEN HEART A & B PACK, Model Number DYNJ0450131AI;  cc.\tVASCULAR PACK-LF, Model Number DYNJ0493141J;  dd.\tRIGHT HEART PACK-LF, Model Number DYNJ0565558U;  ee.\tENDO VASCULAR PACK-LF, Model Number DYNJ0676055N;  ff.\tLOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G;  gg.\tENDOVASCULAR PACK, Model Number DYNJ0678934I;  hh.\tRR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J;  ii.\tELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D;  jj.\tVASCULAR PACK-LF, Model Number DYNJ0871182AC;  kk.\tELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D;  ll.\tEP PACK, Model Number DYNJ16618J;  mm.\tEP PACK, Model Number DYNJ16618K;  nn.\tST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C;  oo.\tVEIN PACK, Model Number DYNJ21949J;  pp.\tVASCULAR PACK, Model Number DYNJ22350L;  qq.\tEP PACK, Model Number DYNJ23456K;  rr.\tANGIO-VASCULAR, Model Number DYNJ24272C;  ss.\tEP ANGIO PACK, Model Number DYNJ25749S;  tt.\tC.V. MINOR PACK, Model Number DYNJ28849B;  uu.\tEP TRAY, Model Number DYNJ31928D;  vv.\tPACER PACK, Model Number DYNJ34844C;  ww.\tADULT CARDIO TRAY, Model Number DYNJ35495G;  xx.\tPEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G;  yy.\tCARDIO B PACK, Model Number DYNJ36052O;  zz.\tVASCULAR ENDO LASER PK, Model Number DYNJ37445I;  aaa.\tVEIN PROCEDURE PACK, Model Number DYNJ38264D;  bbb.\tHMT VEIN PACK, Model Number DYNJ38756B;  ccc.\tLASER AND VEIN PACK, Model Number DYNJ38995C;  ddd.\tVEIN CLOSURE PACK, Model Number DYNJ39408F;  eee.\tCAROTID PACK, Model Number DYNJ39488G;  fff.\tVEIN PACK, Model Number DYNJ39889;  ggg.\tCVL CUSTOM PACK, Model Number DYNJ40067G;  hhh.\tAV GRAFT-LF, Model Number DYNJ40077F;  iii.\tVASCULAR-LF, Model Number DYNJ40108I;  jjj.\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215C;  kkk.\tRIGHT HEART TRAY, Model Number DYNJ40379D;  lll.\tLINE PACK, Model Number DYNJ41100C;  mmm.\tCARDIAC CATH PACK, Model Number DYNJ41195D;  nnn.\tVEIN PK, Model Number DYNJ42976;  ooo.\tVEIN CLOSURE PACK, Model Number DYNJ43085A;  ppp.\tPROCEDURE PACK, Model Number DYNJ43922;  qqq.\tPK, RADIOLOGY-PORTSMOUTH, Model Number DYNJ44087B;  rrr.\tPACEMAKER PACK, Model Number DYNJ44345F;  sss.\tPACEMAKER PACK, Model Number DYNJ44345G;  ttt.\tVENOUS ACCESS PACK, Model Number DYNJ44421D;  uuu.\tVEIN CLOSURE TRAY, Model Number DYNJ44737B;  vvv.\tENDO LASER ABLATION PK-LF, Model Number DYNJ44808G;  www.\tPK, OPEN HEART, Model Number DYNJ45074C;  xxx.\tVASCULAR PACK, Model Number DYNJ46246A;  yyy.\tCVP PACK, Model Number DYNJ46359D;  zzz.\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ47138B;  aaaa.\tEP DRAPE PACK-LF, Model Number DYNJ47645C;  bbbb.\tRF OPEN HEAR",
      "product_quantity": "172722 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 00-401185Q, UDI/DI (EA) 10193489489088, UDI/DI (CS)40193489489089;  b) Model Number CDS840487I, UDI/DI (EA) 10193489445343, UDI/DI (CS)40193489445344;  c) Model Number CDS983147I, UDI/DI (EA) 10195327075514, UDI/DI (CS)40195327075515;  d) Model Number CDS983394I, UDI/DI (EA) 10193489819953, UDI/DI (CS)40193489819954;  e) Model Number CDS983394J, UDI/DI (EA) 10195327069872, UDI/DI (CS)40195327069873;  f) Model Number CDS983394K, UDI/DI (EA) 10195327292584, UDI/DI (CS)40195327292585;  g) Model Number CDS983513F, UDI/DI (EA) 10193489843729, UDI/DI (CS)40193489843720;  h) Model Number CDS983849D, UDI/DI (EA) 10193489278231, UDI/DI (CS)40193489278232;  i) Model Number CDS983849F, UDI/DI (EA) 10195327228316, UDI/DI (CS)40195327228317;  j) Model Number CDS984292I, UDI/DI (EA) 10193489862485, UDI/DI (CS)40193489862486;  k) Model Number CDS984355G, UDI/DI (EA) 10193489484632, UDI/DI (CS)40193489484633;  l) Model Number CDS984642, UDI/DI (EA) 10884389882924, UDI/DI (CS)40884389882925;  m) Model Number CDS984764G, UDI/DI (EA) 10193489450293, UDI/DI (CS)40193489450294;  n) Model Number CDS985105O, UDI/DI (EA) 10195327036249, UDI/DI (CS)40195327036240;  o) Model Number CDS985355D, UDI/DI (EA) 10193489442779, UDI/DI (CS)40193489442770;  p) Model Number CDS985355F, UDI/DI (EA) 10195327242626, UDI/DI (CS)40195327242627;  q) Model Number CVI4955, UDI/DI (EA) 10195327325848, UDI/DI (CS)40195327325849;  r) Model Number DYKMBNDL21, UDI/DI (EA) 10193489478693, UDI/DI (CS)40193489478694;  s) Model Number DYNDA2526, UDI/DI (EA) 10193489191790, UDI/DI (CS)40193489191791;  t) Model Number DYNDC3038, UDI/DI (EA) 10193489493603, UDI/DI (CS)40193489493604;  u) Model Number DYNJ0037939B, UDI/DI (EA) 10195327031275, UDI/DI (CS)40195327031276;  v) Model Number DYNJ0149567C, UDI/DI (EA) 10195327235529, UDI/DI (CS)40195327235520;  w) Model Number DYNJ0201109AJ, UDI/DI (EA) 10195327325459, UDI/DI (CS)40195327325450;  x) Model Number DYNJ0371669N, UDI/DI (EA) 10193489230390, UDI/DI (CS)40193489230391;  y) Model Number DYNJ0408782AA, UDI/DI (EA) 10195327115814, UDI/DI (CS)40195327115815;  z) Model Number DYNJ0429185K, UDI/DI (EA) 10193489728132, UDI/DI (CS)40193489728133;  aa) Model Number DYNJ0429185M, UDI/DI (EA) 10195327371357, UDI/DI (CS)40195327371358;  bb) Model Number DYNJ0450131AI, UDI/DI (EA) 10193489466126, UDI/DI (CS)40193489466127;  cc) Model Number DYNJ0493141J, UDI/DI (EA) 10193489926224, UDI/DI (CS)40193489926225;  dd) Model Number DYNJ0565558U, UDI/DI (EA) 10193489827033, UDI/DI (CS)40193489827034;  ee) Model Number DYNJ0676055N, UDI/DI (EA) 10193489954364, UDI/DI (CS)40193489954365;  ff) Model Number DYNJ0678934G, UDI/DI (EA) 10193489925265, UDI/DI (CS)40193489925266;  gg) Model Number DYNJ0678934I, UDI/DI (EA) 10193489997866, UDI/DI (CS)40193489997867;  hh) Model Number DYNJ0785736J, UDI/DI (EA) 10193489202663, UDI/DI (CS)40193489202664;  ii) Model Number DYNJ0842825D, UDI/DI (EA) 10195327288617, UDI/DI (CS)40195327288618;  jj) Model Number DYNJ0871182AC, UDI/DI (EA) 10195327330859, UDI/DI (CS)40195327330850;  kk) Model Number DYNJ09878D, UDI/DI (EA) 10195327387662, UDI/DI (CS)40195327387663;  ll) Model Number DYNJ16618J, UDI/DI (EA) 10195327249854, UDI/DI (CS)40195327249855;  mm) Model Number DYNJ16618K, UDI/DI (EA) 10195327325572, UDI/DI (CS)40195327325573;  nn) Model Number DYNJ20031C, UDI/DI (EA) 10884389650073, UDI/DI (CS)40884389650074;  oo) Model Number DYNJ21949J, UDI/DI (EA) 10889942128419, UDI/DI (CS)40889942128410;  pp) Model Number DYNJ22350L, UDI/DI (EA) 10193489445251, UDI/DI (CS)40193489445252;  qq) Model Number DYNJ23456K, UDI/DI (EA) 10193489967760, UDI/DI (CS)40193489967761;  rr) Model Number DYNJ24272C, UDI/DI (EA) 10193489620221, UDI/DI (CS)40193489620222;  ss) Model Number DYNJ25749S, UDI/DI (EA) 10195327059705, UDI/DI (CS)40195327059706;  tt) Model Number DYNJ28849B, UDI/DI (EA) 10195327319557, UDI/DI (CS)40195327319558;  uu) Model Number DYNJ31928D, UDI/DI (EA) 10195327335281, UDI/DI (CS)40195327335282;  vv) Model Number DYNJ34844C, UDI/DI (EA) 10193489778076, UDI/DI (CS)40193489778077;  ww) Model Number DYNJ35495G, UDI/DI (EA) 10193489803990, UDI/DI (CS)40193489803991;  xx) Model Number DYNJ35578G, UDI/DI (EA) 10193489808605, UDI/DI (CS)40193489808606;  yy) Model Number DYNJ36052O, UDI/DI (EA) 10195327249533, UDI/DI (CS)40195327249534;  zz) Model Number DYNJ37445I, UDI/DI (EA) 10193489417395, UDI/DI (CS)40193489417396;  aaa) Model Number DYNJ38264D, UDI/DI (EA) 10193489438499, UDI/DI (CS)40193489438490;  bbb) Model Number DYNJ38756B, UDI/DI (EA) 10889942455799, UDI/DI (CS)40889942455790;  ccc) Model Number DYNJ38995C, UDI/DI (EA) 10193489713145, UDI/DI (CS)40193489713146;  ddd) Model Number DYNJ39408F, UDI/DI (EA) 10193489692839, UDI/DI (CS)40193489692830;  eee) Model Number DYNJ39488G, UDI/DI (EA) 10193489383775, UDI/DI (CS)40193489383776;  fff) Model Number DYNJ39889, UDI/DI (EA) 10884389796931, UDI/DI (CS)40884389796932;  ggg) Model Number DYNJ40067G, UDI/DI (EA) 10195327244033, UDI/DI (CS)40195327244034;  hhh) Model Number DYNJ40077F, UDI/DI (EA) 10195327175818, UDI/DI (CS)40195327175819;  iii) Model Number DYNJ40108I, UDI/DI (EA) 10195327284183, UDI/DI (CS)40195327284184;  jjj) Model Number DYNJ40215C, UDI/DI (EA) 10195327176501, UDI/DI (CS)40195327176502;  kkk) Model Number DYNJ40379D, UDI/DI (EA) 10193489257618, UDI/DI (CS)40193489257619;  lll) Model Number DYNJ41100C, UDI/DI (EA) 10193489899825, UDI/DI (CS)40193489899826;  mmm) Model Number DYNJ41195D, UDI/DI (EA) 10193489314250, UDI/DI (CS)40193489314251;  nnn) Model Number DYNJ42976, UDI/DI (EA) 10888277019140, UDI/DI (CS)40888277019141;  ooo) Model Number DYNJ43085A, UDI/DI (EA) 10193489600346, UDI/DI (CS)40193489600347;  ppp) Model Number DYNJ43922, UDI/DI (EA) 10888277074668, UDI/DI (CS)40888277074669;  qqq) Model Number DYNJ44087B, UDI/DI (EA) 10195327346584, UDI/DI (CS)40195327346585;  rrr) Model Number DYNJ44345F, UDI/DI (EA) 10889942966523, UDI/DI (CS)40889942966524;  sss) Model Number DYNJ44345G, UDI/DI (EA) 10193489939507, UDI/DI (CS)40193489939508;  ttt) Model Number DYNJ44421D, UDI/DI (EA) 10193489482638, UDI/DI (CS)40193489482639;  uuu) Model Number DYNJ44737B, UDI/DI (EA) 10193489351712, UDI/DI (CS)40193489351713;  vvv) Model Number DYNJ44808G, UDI/DI (EA) 10193489875850, UDI/DI (CS)40193489875851;  www) Model Number DYNJ45074C, UDI/DI (EA) 10193489222678, UDI/DI (CS)40193489222679;  xxx) Model Number DYNJ46246A, UDI/DI (EA) 10889942584963, UDI/DI (CS)40889942584964;  yyy) Model Number DYNJ46359D, UDI/DI (EA) 10193489961379, UDI/DI (CS)40193489961370;  zzz) Model Number DYNJ47138B, UDI/DI (EA) 10889942274215, UDI/DI (CS)40889942274216;  aaaa) Model Number DYNJ47645C, UDI/DI (EA) 10195327355173, UDI/DI (CS)40195327355174;  bbbb) Model Number DYNJ47660K, UDI/DI (EA) 10193489875737, UDI/DI (CS)40193489875738;  cccc) Model Number DYNJ48365, UDI/DI (EA) 10888277594593, UDI/DI (CS)40888277594594;  dddd) Model Number DYNJ48456C, UDI/DI (EA) 10195327015862, UDI/DI (CS)40195327015863;  eeee) Model Number DYNJ48907F, UDI/DI (EA) 10889942529421, UDI/DI (CS)40889942529422;  ffff) Model Number DYNJ49874, UDI/DI (EA) 10888277890602, UDI/DI (CS)40888277890603;  gggg) Model Number DYNJ49931I, UDI/DI (EA) 10193489939217, UDI/DI (CS)40193489939218;  hhhh) Model Number DYNJ49933I, UDI/DI (EA) 10193489471687, UDI/DI (CS)40193489471688;  iiii) Model Number DYNJ49933J, UDI/DI (EA) 10195327065614, UDI/DI (CS)40195327065615;  jjjj) Model Number DYNJ50227C, UDI/DI (EA) 10889942938612, UDI/DI (CS)40889942938613;  kkkk) Model Number DYNJ50785, UDI/DI (EA) 10889942105304, UDI/DI (CS)40889942105305;  llll) Model Number DYNJ51304C, UDI/DI (EA) 10193489460988, UDI/DI (CS)40193489460989;  mmmm) Model Number DYNJ51925F, UDI/DI (EA) 10195327153397, UDI/DI (CS)40195327153398;  nnnn) Model Number DYNJ52024, UDI/DI (EA) 10889942233359, UDI/DI (CS)40889942233350;  oooo) Model Number DYNJ52056C, UDI/DI (EA) 10193489369441, UDI/DI (CS)40193489369442;  pppp) Model Number DYNJ52056D, UDI/DI (EA) 10195327096137, UDI/DI (CS)40195327096138;  qqqq) Model Number DYNJ52098, UDI/DI (EA) 10889942237067, UDI/DI (CS)40889942237068;  rrrr) Model Number DYNJ52586A, UDI/DI (EA) 10193489494396, UDI/DI (CS)40193489494397;  ssss) Model Number DYNJ52586B, UDI/DI (EA) 10195327212117, UDI/DI (CS)40195327212118;  tttt) Model Number DYNJ52606F, UDI/DI (EA) 10193489343298, UDI/DI (CS)40193489343299;  uuuu) Model Number DYNJ52756A, UDI/DI (EA) 10193489413830, UDI/DI (CS)40193489413831;  vvvv) Model Number DYNJ52766A, UDI/DI (EA) 10193489292367, UDI/DI (CS)40193489292368;  wwww) Model Number DYNJ53433F, UDI/DI (EA) 10193489328677, UDI/DI (CS)40193489328678;  xxxx) Model Number DYNJ53433G, UDI/DI (EA) 10195327042431, UDI/DI (CS)40195327042432;  yyyy) Model Number DYNJ53433I, UDI/DI (EA) 10195327074494, UDI/DI (CS)40195327074495;  zzzz)   Model Number DYNJ53433J, UDI/DI (EA) 10195327222925, UDI/DI (CS)40195327222926;",
      "more_code_info": ""
    }
  ]
}