{
  "@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-2164-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "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",
  "description": "FDA recall Z-2164-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling 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 (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-2164-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "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",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2164-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2164-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling 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",
      "text": "The FDA logged enforcement record Z-2164-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling 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 — 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 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;. 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-2164-2023&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-2164-2023&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-2164-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2164-2023 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-2164-2023&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-2164-2023&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-2164-2023/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-2164-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2164-2023",
            "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 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;",
            "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"
          }
        }
      ]
    }
  ]
}