{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2165-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "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",
  "description": "FDA recall Z-2165-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling 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 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2165-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "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",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2165-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2165-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling 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",
      "text": "The FDA logged enforcement record Z-2165-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling 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 — reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-18. Affected lots/codes: 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;. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2165-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2165-2023&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2165-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2165-2023 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2165-2023&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2165-2023&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2165-2023/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2165-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2165-2023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-18",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "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;",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}