{
  "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-2168-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tPORT PACK, Model Number DYNJ64675;  b)\tPICC LINE TRAY, Model Number DYNJ64725B;  c)\tVEIN OHH, Model Number DYNJ65560C;  d)\tPORT PICC TUNNEL PACK, Model Number DYNJ65775;  e)\tENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827;  f)\tPICC PACK, Model Number DYNJ65838;  g)\tJVL-PACK PICC, Model Number DYNJ66062;  h)\tFISTULAGRAM PACK, Model Number DYNJ66259;  i)\tVEIN PACK-LF, Model Number DYNJ66271B;  j)\tVEIN PACK-LF, Model Number DYNJ66271D;  k)\tVASCULAR PACK, Model Number DYNJ66356F;  l)\tVENOUS PACK, Model Number DYNJ66499A;  m)\tVENOUS PACK, Model Number DYNJ66499B;  n)\tVEIN PACK, Model Number DYNJ66743B;  o)\tAV FISTULA PACK, Model Number DYNJ66916;  p)\tVEIN ABLATION PLUS W CHL, Model Number DYNJ67115A;  q)\tPICC INSERTION TRAY, Model Number DYNJ67415;  r)\tAFCH CVC INSERTION, Model Number DYNJ67534;  s)\tENS PICC LINE-HEJ-LF, Model Number DYNJ67606;  t)\tVEIN TRAY, Model Number DYNJ69012A;  u)\tPICC PACK, Model Number DYNJ69088;  v)\tPICC PACK, Model Number DYNJ69088A;  w)\tVEIN PACK, Model Number DYNJ69091A;  x)\tVEIN PACK, Model Number DYNJ69091B;  y)\tVEIN PACK, Model Number DYNJ69177;  z)\tVEIN ABLATION KIT, Model Number DYNJ69272;  aa)\tVEIN ABLATION PACK, Model Number DYNJ69288;  bb)\tBASIC VEIN PACK, Model Number DYNJ69426;  cc)\tVASCULAR VEIN PACK, Model Number DYNJ69769;  dd)\tBCH VEIN ABLATION, Model Number DYNJ69796;  ee)\tVEIN PACK, Model Number DYNJ69942A;  ff)\tFISTULA SAVANNAH PACK, Model Number DYNJ69943;  gg)\tVEIN CLOSURE PACK, Model Number DYNJ69976;  hh)\tVEIN CLOSURE PACK, Model Number DYNJ69976A;  ii)\tVENCLOSE PROCEDURE PACK, Model Number DYNJ80123;  jj)\tVENOUS PACK, Model Number DYNJ80169;  kk)\tVENOUS PACK, Model Number DYNJ80169A;  ll)\tCVR ENDOVENOUS PACK, Model Number DYNJ80643;  mm)\tVENOUS PACK, Model Number DYNJ80692;  nn)\tVENOUS PACK, Model Number DYNJ80692A;  oo)\tVEIN PACK, Model Number DYNJ81120;  pp)\tVEIN PROCEDURE PACK, Model Number DYNJ81177;  qq)\tVEIN PACK, Model Number DYNJ81212A;  rr)\tSUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267;  ss)\tOR VASCULAR ANGIO PACK, Model Number DYNJ81592;  tt)\tPARAGON VEIN PACK, Model Number DYNJ81669;  uu)\tPARAGON VEIN PACK, Model Number DYNJ81669B;  vv)\tANGIOGRAM-DECH-LF, Model Number DYNJ81725;  ww)\tPICC-DECH-LF, Model Number DYNJ81726;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ81834;  yy)\tVEIN PACK, Model Number DYNJ82033;  zz)\tVEIN PACK, Model Number DYNJ82033A;  aaa)\tSUPERFICIAL VENOUS PACK, Model Number DYNJ82100;  bbb)\tSUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101;  ccc)\tVEIN PROCEDURE TRAY, Model Number DYNJ82581;  ddd)\tVARICOSE VEIN PACK, Model Number DYNJ82884;  eee)\tVARICOSE VEIN PACK, Model Number DYNJ82885;  fff)\tLASER VEIN EC PACK, Model Number DYNJ82951;  ggg)\tSUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989;  hhh)\tPORT DIALYSIS PACK, Model Number DYNJ83087;  iii)\tDEXMED ACCESS PACK, Model Number DYNJ83148;  jjj)\tVEIN TRAY, Model Number DYNJ83384A;  kkk)\tRADIO VEIN ABLATION PACK, Model Number DYNJ83534;  lll)\tVEIN PACK, Model Number DYNJ83747;  mmm)\tVEIN ABLATION PACK, Model Number DYNJ83846;  nnn)\tVEIN PACK, Model Number DYNJ83914;  ooo)\tVEIN PACK, Model Number DYNJ83935;  ppp)\tVEIN ABLATION PACK, Model Number DYNJ83974;  qqq)\tVENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I;  rrr)\tVASCULAR ACCESS-LF, Model Number DYNJ905285D;  sss)\tGENERAL AV FISTULA, Model Number DYNJ906011B;  ttt)\tKIT VEIN ABLATION, Model Number DYNJ907381;  uuu)\tOPEN VASCULAR UE, Model Number DYNJ907858;  vvv)\tPICC LINE TRAY-LF, Model Number DYNJT2272J;  www)\tPICC LINE TRAY-LF, Model Number DYNJT2272K;  xxx)\tPICC CUSTOM PACK, Model Number GSS584Q;  yyy)\tULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A;  zzz)\tPEDS/ NICU LINE KIT, Model Number MNS13555;  aaaa)\tER CENTRAL LINE KIT, Model Number P155508D;  bbbb)\tPICC INSERTION TRAY, Model Number PICC0018;  cccc)\tPICC TRAY, Model Number PICCNC0008;  dddd)\tPQ PICC LINE PACK, Model Number PICCNC0013;  eeee)\tSTANDARD PICC II-LF, Model Number",
      "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 Number DYNJ64675, UDI/DI (EA) 10193489212143,UDI/DI (CS) 40193489212144;  b) Model Number DYNJ64725B, UDI/DI (EA) 10193489452846,UDI/DI (CS) 40193489452847;  c) Model Number DYNJ65560C, UDI/DI (EA) 10195327136819,UDI/DI (CS) 40195327136810;  d) Model Number DYNJ65775, UDI/DI (EA) 10193489289824,UDI/DI (CS) 40193489289825;  e) Model Number DYNJ65827, UDI/DI (EA) 10193489298499,UDI/DI (CS) 40193489298490;  f) Model Number DYNJ65838, UDI/DI (EA) 10193489303261,UDI/DI (CS) 40193489303262;  g) Model Number DYNJ66062, UDI/DI (EA) 10193489319217,UDI/DI (CS) 40193489319218;  h) Model Number DYNJ66259, UDI/DI (EA) 10193489325485,UDI/DI (CS) 40193489325486;  i) Model Number DYNJ66271B, UDI/DI (EA) 10193489998917,UDI/DI (CS) 40193489998918;  j) Model Number DYNJ66271D, UDI/DI (EA) 10195327130749,UDI/DI (CS) 40195327130740;  k) Model Number DYNJ66356F, UDI/DI (EA) 10195327160012,UDI/DI (CS) 40195327160013;  l) Model Number DYNJ66499A, UDI/DI (EA) 10193489977523,UDI/DI (CS) 40193489977524;  m) Model Number DYNJ66499B, UDI/DI (EA) 10195327242107,UDI/DI (CS) 40195327242108;  n) Model Number DYNJ66743B, UDI/DI (EA) 10193489949797,UDI/DI (CS) 40193489949798;  o) Model Number DYNJ66916, UDI/DI (EA) 10193489387650,UDI/DI (CS) 40193489387651;  p) Model Number DYNJ67115A, UDI/DI (EA) 10195327091880,UDI/DI (CS) 40195327091881;  q) Model Number DYNJ67415, UDI/DI (EA) 10193489930887,UDI/DI (CS) 40193489930888;  r) Model Number DYNJ67534, UDI/DI (EA) 10193489409321,UDI/DI (CS) 40193489409322;  s) Model Number DYNJ67606, UDI/DI (EA) 10193489421675,UDI/DI (CS) 40193489421676;  t) Model Number DYNJ69012A, UDI/DI (EA) 10195327331719,UDI/DI (CS) 40195327331710;  u) Model Number DYNJ69088, UDI/DI (EA) 10193489883619,UDI/DI (CS) 40193489883610;  v) Model Number DYNJ69088A, UDI/DI (EA) 10193489975246,UDI/DI (CS) 40193489975247;  w) Model Number DYNJ69091A, UDI/DI (EA) 10193489969764,UDI/DI (CS) 40193489969765;  x) Model Number DYNJ69091B, UDI/DI (EA) 10195327178994,UDI/DI (CS) 40195327178995;  y) Model Number DYNJ69177, UDI/DI (EA) 10193489902198,UDI/DI (CS) 40193489902199;  z) Model Number DYNJ69272, UDI/DI (EA) 10193489920338,UDI/DI (CS) 40193489920339;  aa) Model Number DYNJ69288, UDI/DI (EA) 10193489922677,UDI/DI (CS) 40193489922678;  bb) Model Number DYNJ69426, UDI/DI (EA) 10193489939392,UDI/DI (CS) 40193489939393;  cc) Model Number DYNJ69769, UDI/DI (EA) 10193489977790,UDI/DI (CS) 40193489977791;  dd) Model Number DYNJ69796, UDI/DI (EA) 10193489979350,UDI/DI (CS) 40193489979351;  ee) Model Number DYNJ69942A, UDI/DI (EA) 10195327284626,UDI/DI (CS) 40195327284627;  ff) Model Number DYNJ69943, UDI/DI (EA) 10193489998443,UDI/DI (CS) 40193489998444;  gg) Model Number DYNJ69976, UDI/DI (EA) 10195327001308,UDI/DI (CS) 40195327001309;  hh) Model Number DYNJ69976A, UDI/DI (EA) 10195327130398,UDI/DI (CS) 40195327130399;  ii) Model Number DYNJ80123, UDI/DI (EA) 10195327009182,UDI/DI (CS) 40195327009183;  jj) Model Number DYNJ80169, UDI/DI (EA) 10195327013448,UDI/DI (CS) 40195327013449;  kk) Model Number DYNJ80169A, UDI/DI (EA) 10195327169749,UDI/DI (CS) 40195327169740;  ll) Model Number DYNJ80643, UDI/DI (EA) 10195327055790,UDI/DI (CS) 40195327055791;  mm) Model Number DYNJ80692, UDI/DI (EA) 10195327065546,UDI/DI (CS) 40195327065547;  nn) Model Number DYNJ80692A, UDI/DI (EA) 10195327340827,UDI/DI (CS) 40195327340828;  oo) Model Number DYNJ81120, UDI/DI (EA) 10195327085889,UDI/DI (CS) 40195327085880;  pp) Model Number DYNJ81177, UDI/DI (EA) 10195327089610,UDI/DI (CS) 40195327089611;  qq) Model Number DYNJ81212A, UDI/DI (EA) 10195327159863,UDI/DI (CS) 40195327159864;  rr) Model Number DYNJ81267, UDI/DI (EA) 10195327101442,UDI/DI (CS) 40195327101443;  ss) Model Number DYNJ81592, UDI/DI (EA) 10195327123772,UDI/DI (CS) 40195327123773;  tt) Model Number DYNJ81669, UDI/DI (EA) 10195327132323,UDI/DI (CS) 40195327132324;  uu) Model Number DYNJ81669B, UDI/DI (EA) 10195327253431,UDI/DI (CS) 40195327253432;  vv) Model Number DYNJ81725, UDI/DI (EA) 10195327136758,UDI/DI (CS) 40195327136759;  ww) Model Number DYNJ81726, UDI/DI (EA) 10195327136772,UDI/DI (CS) 40195327136773;  xx) Model Number DYNJ81834, UDI/DI (EA) 10195327147853,UDI/DI (CS) 40195327147854;  yy) Model Number DYNJ82033, UDI/DI (EA) 10195327162979,UDI/DI (CS) 40195327162970;  zz) Model Number DYNJ82033A, UDI/DI (EA) 10195327271442,UDI/DI (CS) 40195327271443;  aaa) Model Number DYNJ82100, UDI/DI (EA) 10195327170592,UDI/DI (CS) 40195327170593;  bbb) Model Number DYNJ82101, UDI/DI (EA) 10195327170585,UDI/DI (CS) 40195327170586;  ccc) Model Number DYNJ82581, UDI/DI (EA) 10195327198657,UDI/DI (CS) 40195327198658;  ddd) Model Number DYNJ82884, UDI/DI (EA) 10195327215996,UDI/DI (CS) 40195327215997;  eee) Model Number DYNJ82885, UDI/DI (EA) 10195327216009,UDI/DI (CS) 40195327216000;  fff) Model Number DYNJ82951, UDI/DI (EA) 10195327218973,UDI/DI (CS) 40195327218974;  ggg) Model Number DYNJ82989, UDI/DI (EA) 10195327221768,UDI/DI (CS) 40195327221769;  hhh) Model Number DYNJ83087, UDI/DI (EA) 10195327231255,UDI/DI (CS) 40195327231256;  iii) Model Number DYNJ83148, UDI/DI (EA) 10195327235512,UDI/DI (CS) 40195327235513;  jjj) Model Number DYNJ83384A, UDI/DI (EA) 10195327304812,UDI/DI (CS) 40195327304813;  kkk) Model Number DYNJ83534, UDI/DI (EA) 10195327276713,UDI/DI (CS) 40195327276714;  lll) Model Number DYNJ83747, UDI/DI (EA) 10195327300739,UDI/DI (CS) 40195327300730;  mmm) Model Number DYNJ83846, UDI/DI (EA) 10195327311490,UDI/DI (CS) 40195327311491;  nnn) Model Number DYNJ83914, UDI/DI (EA) 10195327313128,UDI/DI (CS) 40195327313129;  ooo) Model Number DYNJ83935, UDI/DI (EA) 10195327318543,UDI/DI (CS) 40195327318544;  ppp) Model Number DYNJ83974, UDI/DI (EA) 10195327323141,UDI/DI (CS) 40195327323142;  qqq) Model Number DYNJ902602I, UDI/DI (EA) 10193489892567,UDI/DI (CS) 40193489892568;  rrr) Model Number DYNJ905285D, UDI/DI (EA) 10195327062668,UDI/DI (CS) 40195327062669;  sss) Model Number DYNJ906011B, UDI/DI (EA) 10193489411232,UDI/DI (CS) 40193489411233;  ttt) Model Number DYNJ907381, UDI/DI (EA) 10193489900774,UDI/DI (CS) 40193489900775;  uuu) Model Number DYNJ907858, UDI/DI (EA) 10193489909357,UDI/DI (CS) 40193489909358;  vvv) Model Number DYNJT2272J, UDI/DI (EA) 10889942426324,UDI/DI (CS) 40889942426325;  www) Model Number DYNJT2272K, UDI/DI (EA) 10195327250676,UDI/DI (CS) 40195327250677;  xxx) Model Number GSS584Q, UDI/DI (EA) 10193489941029,UDI/DI (CS) 40193489941020;  yyy) Model Number IVS3635A, UDI/DI (EA) 10193489362916,UDI/DI (CS) 40193489362917;  zzz) Model Number MNS13555, UDI/DI (EA) 10653160991953,UDI/DI (CS) 40653160991954;  aaaa) Model Number P155508D, UDI/DI (EA) 10193489899061,UDI/DI (CS) 40193489899062;  bbbb) Model Number PICC0018, UDI/DI (EA) 10195327327392,UDI/DI (CS) 40195327327393;  cccc) Model Number PICCNC0008, UDI/DI (EA) 10195327221584,UDI/DI (CS) 40195327221585;  dddd) Model Number PICCNC0013, UDI/DI (EA) 10195327311223,UDI/DI (CS) 40195327311224;  eeee) Model Number PICCNC002, UDI/DI (EA) 10193489877199,UDI/DI (CS) 40193489877190;  ffff) Model Number VC-PP-6F12, UDI/DI (EA) 10193489576658,UDI/DI (CS) 40193489576659;  gggg) Model Number VC-PPH-6F12A, UDI/DI (EA) 10193489423105,UDI/DI (CS) 40193489423106;  hhhh) Model Number VC-PPH-6F7A, UDI/DI (EA) 10193489423099,UDI/DI (CS) 40193489423090;  iiii) Model Number VC-PPM-12F, UDI/DI (EA) 10193489422689,UDI/DI (CS) 40193489422680;",
      "more_code_info": ""
    }
  ]
}