{
  "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-2166-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102G;  b)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102I;  c)\tCUSTOM CARDIAC CABG, Model Number DYNJ906108C;  d)\tVASCULAR STENT INOVA, Model Number DYNJ906440A;  e)\tCABG, Model Number DYNJ906878A;  f)\tVALVE, Model Number DYNJ906882A;  g)\tVASCULAR, Model Number DYNJ906883A;  h)\tDR WILLIAMS HEART, Model Number DYNJ907552A;  i)\tPUH PERCUTANEOUS ECMO, Model Number DYNJ907554C;  j)\tTAVR, Model Number DYNJ907561A;  k)\tTAVR, Model Number DYNJ907561B;  l)\tTAVR, Model Number DYNJ907561C;  m)\tOPEN HEART CDS, Model Number DYNJ907607A;  n)\tOPEN HEART CDS, Model Number DYNJ907607B;  o)\tOPEN HEART CDS, Model Number DYNJ907607C;  p)\tOPEN VASCULAR UE, Model Number DYNJ907858A;  q)\tPACEMAKER, Model Number DYNJ907907;  r)\tDEBOER HEART, Model Number DYNJ907914A;  s)\tDEBOER HEART, Model Number DYNJ907914B;  t)\tDEBOER HEART, Model Number DYNJ907914C;  u)\tGENERAL HEART, Model Number DYNJ907915;  v)\tAV FISTULA, Model Number DYNJ907975;  w)\tAV FISTULA, Model Number DYNJ907975A;  x)\tAV FISTULA, Model Number DYNJ907975B;  y)\tSAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B;  z)\tCARDIAC CABG B, Model Number DYNJ908121B;  aa)\tOPEN HEART LINE SET UP, Model Number DYNJ908179A;  bb)\tSTEWARD VASCULAR SAS, Model Number DYNJ908563;  cc)\tTAVR, Model Number DYNJ908646;  dd)\tTAVR, Model Number DYNJ908646A;  ee)\tENDOVASCULAR, Model Number DYNJ908880;  ff)\tENDOVASCULAR, Model Number DYNJ908880A;  gg)\tVASCULAR, Model Number DYNJ909091;  hh)\tENDOVASCULAR, Model Number DYNJ909253;  ii)\tTAVR, Model Number DYNJ909270;  jj)\tCABG, Model Number DYNJ9372030G;  kk)\tOPEN HEART, Model Number DYNJ9718008AS;  ll)\tADULT CORONARY PACK, Model Number DYNJV0275M;  mm)\tRADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A;  nn)\tVASCULAR PACK, Model Number DYNJVB1307;  oo)\tVASCULAR PACK, Model Number DYNJVB1307A;  pp)\tVASCULAR EXTREMITY PPS, Model Number DYNJVB91063C;  qq)\tENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067;  rr)\tPERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A;  ss)\tVEIN PACK-LF, Model Number PHS151095000;  tt)\tE P PACK-LF, Model Number PHS41732B;  uu)\tPICC VASCULAR ACCESS PACK, Model Number PICCNC0010;  vv)\tTVS4000 ENDOVENOUS PACK, Model Number TVS4000L;",
      "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 DYNJ906102G, UDI/DI (EA)10195327290795, UDI/DI (CS)40195327290796;  b) Model Numbers DYNJ906102I, UDI/DI (EA)10195327323349, UDI/DI (CS)40195327323340;  c) Model Numbers DYNJ906108C, UDI/DI (EA)10195327118273, UDI/DI (CS)40195327118274;  d) Model Numbers DYNJ906440A, UDI/DI (EA)10193489312874, UDI/DI (CS)40193489312875;  e) Model Numbers DYNJ906878A, UDI/DI (EA)10193489391305, UDI/DI (CS)40193489391306;  f) Model Numbers DYNJ906882A, UDI/DI (EA)10193489391237, UDI/DI (CS)40193489391238;  g) Model Numbers DYNJ906883A, UDI/DI (EA)10193489398205, UDI/DI (CS)40193489398206;  h) Model Numbers DYNJ907552A, UDI/DI (EA)10195327166052, UDI/DI (CS)40195327166053;  i) Model Numbers DYNJ907554C, UDI/DI (EA)10195327183837, UDI/DI (CS)40195327183838;  j) Model Numbers DYNJ907561A, UDI/DI (EA)10195327028848, UDI/DI (CS)40195327028849;  k) Model Numbers DYNJ907561B, UDI/DI (EA)10195327290832, UDI/DI (CS)40195327290833;  l) Model Numbers DYNJ907561C, UDI/DI (EA)10195327323271, UDI/DI (CS)40195327323272;  m) Model Numbers DYNJ907607A, UDI/DI (EA)10193489873405, UDI/DI (CS)40193489873406;  n) Model Numbers DYNJ907607B, UDI/DI (EA)10195327174194, UDI/DI (CS)40195327174195;  o) Model Numbers DYNJ907607C, UDI/DI (EA)10195327335519, UDI/DI (CS)40195327335510;  p) Model Numbers DYNJ907858A, UDI/DI (EA)10195327131357, UDI/DI (CS)40195327131358;  q) Model Numbers DYNJ907907, UDI/DI (EA)10193489939736, UDI/DI (CS)40193489939737;  r) Model Numbers DYNJ907914A, UDI/DI (EA)10195327149529, UDI/DI (CS)40195327149520;  s) Model Numbers DYNJ907914B, UDI/DI (EA)10195327180607, UDI/DI (CS)40195327180608;  t) Model Numbers DYNJ907914C, UDI/DI (EA)10195327329433, UDI/DI (CS)40195327329434;  u) Model Numbers DYNJ907915, UDI/DI (EA)10193489943689, UDI/DI (CS)40193489943680;  v) Model Numbers DYNJ907975, UDI/DI (EA)10193489965605, UDI/DI (CS)40193489965606;  w) Model Numbers DYNJ907975A, UDI/DI (EA)10195327155070, UDI/DI (CS)40195327155071;  x) Model Numbers DYNJ907975B, UDI/DI (EA)10195327376291, UDI/DI (CS)40195327376292;  y) Model Numbers DYNJ908074B, UDI/DI (EA)10195327172688, UDI/DI (CS)40195327172689;  z) Model Numbers DYNJ908121B, UDI/DI (EA)10195327095710, UDI/DI (CS)40195327095711;  aa) Model Numbers DYNJ908179A, UDI/DI (EA)10195327222574, UDI/DI (CS)40195327222575;  bb) Model Numbers DYNJ908563, UDI/DI (EA)10195327086428, UDI/DI (CS)40195327086429;  cc) Model Numbers DYNJ908646, UDI/DI (EA)10195327123956, UDI/DI (CS)40195327123957;  dd) Model Numbers DYNJ908646A, UDI/DI (EA)10195327314965, UDI/DI (CS)40195327314966;  ee) Model Numbers DYNJ908880, UDI/DI (EA)10195327203436, UDI/DI (CS)40195327203437;  ff) Model Numbers DYNJ908880A, UDI/DI (EA)10195327259198, UDI/DI (CS)40195327259199;  gg) Model Numbers DYNJ909091, UDI/DI (EA)10195327268602, UDI/DI (CS)40195327268603;  hh) Model Numbers DYNJ909253, UDI/DI (EA)10195327317027, UDI/DI (CS)40195327317028;  ii) Model Numbers DYNJ909270, UDI/DI (EA)10195327317171, UDI/DI (CS)40195327317172;  jj) Model Numbers DYNJ9372030G, UDI/DI (EA)10195327025434, UDI/DI (CS)40195327025435;  kk) Model Numbers DYNJ9718008AS, UDI/DI (EA)10193489263121, UDI/DI (CS)40193489263122;  ll) Model Numbers DYNJV0275M, UDI/DI (EA)10195327018627, UDI/DI (CS)40195327018628;  mm) Model Numbers DYNJVB1302A, UDI/DI (EA)10193489928341, UDI/DI (CS)40193489928342;  nn) Model Numbers DYNJVB1307, UDI/DI (EA)10193489872910, UDI/DI (CS)40193489872911;  oo) Model Numbers DYNJVB1307A, UDI/DI (EA)10195327227333, UDI/DI (CS)40195327227334;  pp) Model Numbers DYNJVB91063C, UDI/DI (EA)10195327257125, UDI/DI (CS)40195327257126;  qq) Model Numbers DYNJVB91067, UDI/DI (EA)10193489801538, UDI/DI (CS)40193489801539;  rr) Model Numbers PAIN1423A, UDI/DI (EA)10193489201826, UDI/DI (CS)40193489201827;  ss) Model Numbers PHS151095000, UDI/DI (EA)10889942035601, UDI/DI (CS)40889942035602;  tt) Model Numbers PHS41732B, UDI/DI (EA)10193489784817, UDI/DI (CS)40193489784818;  uu) Model Numbers PICCNC0010, UDI/DI (EA)10195327231170, UDI/DI (CS)40195327231171;  vv) Model Numbers TVS4000L, UDI/DI (EA)10195327223540, UDI/DI (CS)40195327223541;",
      "more_code_info": ""
    }
  ]
}