{
  "@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-2161-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY PACK, Model Number DYNJ55252C;  b)\tCATH LAB PACK, Model Number DYNJ55455A;  c)\tCATH LAB 2, Model Number DYNJ55680A;  d)\tIR ANGIO TRAY, Model Number DYNJ56038A;  e)\tCATH PACK, Model Number DYNJ56547C;  f)\tHYBRID, Model Number DYNJ57049G;  g)\tHYBRID, Model Number DYNJ57049I;  h)\tHYBRID, Model Number DYNJ57049J;  i)\tPERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C;  j)\tGENERAL ANGIO PACK, Model Number DYNJ57760C;  k)\tENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C;  l)\tANGIO PACK, Model Number DYNJ58111D;  m)\tANGIO PACK, Model Number DYNJ58111F;  n)\tPORT PACK, Model Number DYNJ58162;  o)\tENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B;  p)\tPERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A;  q)\tOR ANGIO PACK, Model Number DYNJ59184B;  r)\tPORT A CATH PACK, Model Number DYNJ59307F;  s)\tCATH PACK, Model Number DYNJ59632D;  t)\tPACK PERCUTANEOUS ANGIO  CHRG, Model Number DYNJ60112B;  u)\tI.R. PACK, Model Number DYNJ60343B;  v)\tI.R. PACK, Model Number DYNJ60343C;  w)\tCATH LAB PACK, Model Number DYNJ60763;  x)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082C;  y)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082D;  z)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099B;  aa)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099C;  bb)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118C;  cc)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118D;  dd)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118F;  ee)\tMAIN OR CATH LAB, Model Number DYNJ61373A;  ff)\tCARDIAC CATH PACK-LF, Model Number DYNJ61527A;  gg)\tIR PACK, Model Number DYNJ61646A;  hh)\tPERMA CATH PACK, Model Number DYNJ62007A;  ii)\tIR PACK, Model Number DYNJ62037D;  jj)\tAV FISTULA PACK, Model Number DYNJ62733A;  kk)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ63060B;  ll)\tCATH PACK, Model Number DYNJ63181A;  mm)\tCATH PACK, Model Number DYNJ63181B;  nn)\tCATH PACK, Model Number DYNJ63181C;  oo)\tCATH ANGIO PACK, Model Number DYNJ64050A;  pp)\tANGIOPLASTY PACK-LF, Model Number DYNJ64655C;  qq)\tIR GENERAL PACK, Model Number DYNJ64976;  rr)\tHEART TAVR PACK, Model Number DYNJ65174D;  ss)\tANGIOGRAPHY PACK, Model Number DYNJ65190D;  tt)\tANGIOGRAPHY PACK, Model Number DYNJ65190F;  uu)\tPACK,CARDIAC CATH, Model Number DYNJ65481;  vv)\tRADIOFREQUENCY ABLATION PACK, Model Number DYNJ65913;  ww)\tCATH LAB PACK, Model Number DYNJ66166A;  xx)\tCATH I W SPLIT DRAPE PACK, Model Number DYNJ66182;  yy)\tPORT A CATH INSERT PK, Model Number DYNJ66257;  zz)\tPORT A CATH INSERT PK, Model Number DYNJ66257A;  aaa)\tPORT A CATH INSERT PK, Model Number DYNJ66257B;  bbb)\tFISTULAGRAM PACK, Model Number DYNJ66259A;  ccc)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260A;  ddd)\tCATH PACK, Model Number DYNJ66473A;  eee)\tANGIOGRAPHY PACK, Model Number DYNJ66476A;  fff)\tFEMORAL PACK, Model Number DYNJ66515A;  ggg)\tIR PACK UNION, Model Number DYNJ66926A;  hhh)\tSTANDARD ANGIO TRAY MV, Model Number DYNJ67136A;  iii)\tANGIOGRAPHY PACK, Model Number DYNJ67144A;  jjj)\tDRAINAGE PROCEDURE PACK, Model Number DYNJ67149A;  kkk)\tCARDIAC CATH PACK, Model Number DYNJ67174A;  lll)\tCARDIAC CATH PACK, Model Number DYNJ67174B;  mmm)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245A;  nnn)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245B;  ooo)\tANGIOGRAPHIC TRAY, Model Number DYNJ67320A;  ppp)\tIR PACK, Model Number DYNJ67737;  qqq)\tTUNNEL LINE PACK, Model Number DYNJ67990A;  rrr)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065B;  sss)\tNEURO RADIOLOGY RICHMOND, Model Number DYNJ68365B;  ttt)\tIR PACK, Model Number DYNJ68538;  uuu)\tSPECIAL PROCEDURE CATH LAB PK, Model Number DYNJ68729;  vvv)\tIR PACK, Model Number DYNJ68729B;  www)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763;  xxx)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763A;  yyy)\tIR RADIOLOGY PACK, Model Number DYNJ69056;  zzz)\tIR RADIOLOGY PACK, Model Number DYNJ69056A;  aaaa)\tANGIO PACK, Model Number DYNJ69200;  bbbb)\tHGH TAVI PACK, Model Number DYNJ69298;  cccc)\tANGIO TRAY, Model Number DYNJ69421;  dddd)\tENDOV",
  "description": "FDA recall Z-2161-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY PACK, Model Number DYNJ55252C;  b)\tCATH LAB PACK, Model Number DYNJ55455A;  c)\tCATH LAB 2, Model Number DYNJ55680A;  d)\tIR ANGIO TRAY, Model Number DYNJ56038A;  e)\tCATH PACK, Model Number DYNJ56547C;  f)\tHYBRID, Model Number DYNJ57049G;  g)\tHYBRID, Model Number DYNJ57049I;  h)\tHYBRID, Model Number DYNJ57049J;  i)\tPERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C;  j)\tGENERAL ANGIO PACK, Model Number DYNJ57760C;  k)\tENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C;  l)\tANGIO PACK, Model Number DYNJ58111D;  m)\tANGIO PACK, Model Number DYNJ58111F;  n)\tPORT PACK, Model Number DYNJ58162;  o)\tENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B;  p)\tPERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A;  q)\tOR ANGIO PACK, Model Number DYNJ59184B;  r)\tPORT A CATH PACK, Model Number DYNJ59307F;  s)\tCATH PACK, Model Number DYNJ59632D;  t)\tPACK PERCUTANEOUS ANGIO  CHRG, Model Number DYNJ60112B;  u)\tI.R. PACK, Model Number DYNJ60343B;  v)\tI.R. PACK, Model Number DYNJ60343C;  w)\tCATH LAB PACK, Model Number DYNJ60763;  x)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082C;  y)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082D;  z)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099B;  aa)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099C;  bb)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118C;  cc)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118D;  dd)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118F;  ee)\tMAIN OR CATH LAB, Model Number DYNJ61373A;  ff)\tCARDIAC CATH PACK-LF, Model Number DYNJ61527A;  gg)\tIR PACK, Model Number DYNJ61646A;  hh)\tPERMA CATH PACK, Model Number DYNJ62007A;  ii)\tIR PACK, Model Number DYNJ62037D;  jj)\tAV FISTULA PACK, Model Number DYNJ62733A;  kk)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ63060B;  ll)\tCATH PACK, Model Number DYNJ63181A;  mm)\tCATH PACK, Model Number DYNJ63181B;  nn)\tCATH PACK, Model Number DYNJ63181C;  oo)\tCATH ANGIO PACK, Model Number DYNJ64050A;  pp)\tANGIOPLASTY PACK-LF, Model Number DYNJ64655C;  qq)\tIR GENERAL PACK, Model Number DYNJ64976;  rr)\tHEART TAVR PACK, Model Number DYNJ65174D;  ss)\tANGIOGRAPHY PACK, Model Number DYNJ65190D;  tt)\tANGIOGRAPHY PACK, Model Number DYNJ65190F;  uu)\tPACK,CARDIAC CATH, Model Number DYNJ65481;  vv)\tRADIOFREQUENCY ABLATION PACK, Model Number DYNJ65913;  ww)\tCATH LAB PACK, Model Number DYNJ66166A;  xx)\tCATH I W SPLIT DRAPE PACK, Model Number DYNJ66182;  yy)\tPORT A CATH INSERT PK, Model Number DYNJ66257;  zz)\tPORT A CATH INSERT PK, Model Number DYNJ66257A;  aaa)\tPORT A CATH INSERT PK, Model Number DYNJ66257B;  bbb)\tFISTULAGRAM PACK, Model Number DYNJ66259A;  ccc)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260A;  ddd)\tCATH PACK, Model Number DYNJ66473A;  eee)\tANGIOGRAPHY PACK, Model Number DYNJ66476A;  fff)\tFEMORAL PACK, Model Number DYNJ66515A;  ggg)\tIR PACK UNION, Model Number DYNJ66926A;  hhh)\tSTANDARD ANGIO TRAY MV, Model Number DYNJ67136A;  iii)\tANGIOGRAPHY PACK, Model Number DYNJ67144A;  jjj)\tDRAINAGE PROCEDURE PACK, Model Number DYNJ67149A;  kkk)\tCARDIAC CATH PACK, Model Number DYNJ67174A;  lll)\tCARDIAC CATH PACK, Model Number DYNJ67174B;  mmm)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245A;  nnn)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245B;  ooo)\tANGIOGRAPHIC TRAY, Model Number DYNJ67320A;  ppp)\tIR PACK, Model Number DYNJ67737;  qqq)\tTUNNEL LINE PACK, Model Number DYNJ67990A;  rrr)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065B;  sss)\tNEURO RADIOLOGY RICHMOND, Model Number DYNJ68365B;  ttt)\tIR PACK, Model Number DYNJ68538;  uuu)\tSPECIAL PROCEDURE CATH LAB PK, Model Number DYNJ68729;  vvv)\tIR PACK, Model Number DYNJ68729B;  www)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763;  xxx)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763A;  yyy)\tIR RADIOLOGY PACK, Model Number DYNJ69056;  zzz)\tIR RADIOLOGY PACK, Model Number DYNJ69056A;  aaaa)\tANGIO PACK, Model Number DYNJ69200;  bbbb)\tHGH TAVI PACK, Model Number DYNJ69298;  cccc)\tANGIO TRAY, Model Number DYNJ69421;  dddd)\tENDOV (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-2161-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY PACK, Model Number DYNJ55252C;  b)\tCATH LAB PACK, Model Number DYNJ55455A;  c)\tCATH LAB 2, Model Number DYNJ55680A;  d)\tIR ANGIO TRAY, Model Number DYNJ56038A;  e)\tCATH PACK, Model Number DYNJ56547C;  f)\tHYBRID, Model Number DYNJ57049G;  g)\tHYBRID, Model Number DYNJ57049I;  h)\tHYBRID, Model Number DYNJ57049J;  i)\tPERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C;  j)\tGENERAL ANGIO PACK, Model Number DYNJ57760C;  k)\tENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C;  l)\tANGIO PACK, Model Number DYNJ58111D;  m)\tANGIO PACK, Model Number DYNJ58111F;  n)\tPORT PACK, Model Number DYNJ58162;  o)\tENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B;  p)\tPERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A;  q)\tOR ANGIO PACK, Model Number DYNJ59184B;  r)\tPORT A CATH PACK, Model Number DYNJ59307F;  s)\tCATH PACK, Model Number DYNJ59632D;  t)\tPACK PERCUTANEOUS ANGIO  CHRG, Model Number DYNJ60112B;  u)\tI.R. PACK, Model Number DYNJ60343B;  v)\tI.R. PACK, Model Number DYNJ60343C;  w)\tCATH LAB PACK, Model Number DYNJ60763;  x)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082C;  y)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082D;  z)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099B;  aa)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099C;  bb)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118C;  cc)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118D;  dd)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118F;  ee)\tMAIN OR CATH LAB, Model Number DYNJ61373A;  ff)\tCARDIAC CATH PACK-LF, Model Number DYNJ61527A;  gg)\tIR PACK, Model Number DYNJ61646A;  hh)\tPERMA CATH PACK, Model Number DYNJ62007A;  ii)\tIR PACK, Model Number DYNJ62037D;  jj)\tAV FISTULA PACK, Model Number DYNJ62733A;  kk)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ63060B;  ll)\tCATH PACK, Model Number DYNJ63181A;  mm)\tCATH PACK, Model Number DYNJ63181B;  nn)\tCATH PACK, Model Number DYNJ63181C;  oo)\tCATH ANGIO PACK, Model Number DYNJ64050A;  pp)\tANGIOPLASTY PACK-LF, Model Number DYNJ64655C;  qq)\tIR GENERAL PACK, Model Number DYNJ64976;  rr)\tHEART TAVR PACK, Model Number DYNJ65174D;  ss)\tANGIOGRAPHY PACK, Model Number DYNJ65190D;  tt)\tANGIOGRAPHY PACK, Model Number DYNJ65190F;  uu)\tPACK,CARDIAC CATH, Model Number DYNJ65481;  vv)\tRADIOFREQUENCY ABLATION PACK, Model Number DYNJ65913;  ww)\tCATH LAB PACK, Model Number DYNJ66166A;  xx)\tCATH I W SPLIT DRAPE PACK, Model Number DYNJ66182;  yy)\tPORT A CATH INSERT PK, Model Number DYNJ66257;  zz)\tPORT A CATH INSERT PK, Model Number DYNJ66257A;  aaa)\tPORT A CATH INSERT PK, Model Number DYNJ66257B;  bbb)\tFISTULAGRAM PACK, Model Number DYNJ66259A;  ccc)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260A;  ddd)\tCATH PACK, Model Number DYNJ66473A;  eee)\tANGIOGRAPHY PACK, Model Number DYNJ66476A;  fff)\tFEMORAL PACK, Model Number DYNJ66515A;  ggg)\tIR PACK UNION, Model Number DYNJ66926A;  hhh)\tSTANDARD ANGIO TRAY MV, Model Number DYNJ67136A;  iii)\tANGIOGRAPHY PACK, Model Number DYNJ67144A;  jjj)\tDRAINAGE PROCEDURE PACK, Model Number DYNJ67149A;  kkk)\tCARDIAC CATH PACK, Model Number DYNJ67174A;  lll)\tCARDIAC CATH PACK, Model Number DYNJ67174B;  mmm)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245A;  nnn)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245B;  ooo)\tANGIOGRAPHIC TRAY, Model Number DYNJ67320A;  ppp)\tIR PACK, Model Number DYNJ67737;  qqq)\tTUNNEL LINE PACK, Model Number DYNJ67990A;  rrr)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065B;  sss)\tNEURO RADIOLOGY RICHMOND, Model Number DYNJ68365B;  ttt)\tIR PACK, Model Number DYNJ68538;  uuu)\tSPECIAL PROCEDURE CATH LAB PK, Model Number DYNJ68729;  vvv)\tIR PACK, Model Number DYNJ68729B;  www)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763;  xxx)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763A;  yyy)\tIR RADIOLOGY PACK, Model Number DYNJ69056;  zzz)\tIR RADIOLOGY PACK, Model Number DYNJ69056A;  aaaa)\tANGIO PACK, Model Number DYNJ69200;  bbbb)\tHGH TAVI PACK, Model Number DYNJ69298;  cccc)\tANGIO TRAY, Model Number DYNJ69421;  dddd)\tENDOV",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2161-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2161-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY PACK, Model Number DYNJ55252C;  b)\tCATH LAB PACK, Model Number DYNJ55455A;  c)\tCATH LAB 2, Model Number DYNJ55680A;  d)\tIR ANGIO TRAY, Model Number DYNJ56038A;  e)\tCATH PACK, Model Number DYNJ56547C;  f)\tHYBRID, Model Number DYNJ57049G;  g)\tHYBRID, Model Number DYNJ57049I;  h)\tHYBRID, Model Number DYNJ57049J;  i)\tPERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C;  j)\tGENERAL ANGIO PACK, Model Number DYNJ57760C;  k)\tENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C;  l)\tANGIO PACK, Model Number DYNJ58111D;  m)\tANGIO PACK, Model Number DYNJ58111F;  n)\tPORT PACK, Model Number DYNJ58162;  o)\tENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B;  p)\tPERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A;  q)\tOR ANGIO PACK, Model Number DYNJ59184B;  r)\tPORT A CATH PACK, Model Number DYNJ59307F;  s)\tCATH PACK, Model Number DYNJ59632D;  t)\tPACK PERCUTANEOUS ANGIO  CHRG, Model Number DYNJ60112B;  u)\tI.R. PACK, Model Number DYNJ60343B;  v)\tI.R. PACK, Model Number DYNJ60343C;  w)\tCATH LAB PACK, Model Number DYNJ60763;  x)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082C;  y)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082D;  z)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099B;  aa)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099C;  bb)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118C;  cc)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118D;  dd)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118F;  ee)\tMAIN OR CATH LAB, Model Number DYNJ61373A;  ff)\tCARDIAC CATH PACK-LF, Model Number DYNJ61527A;  gg)\tIR PACK, Model Number DYNJ61646A;  hh)\tPERMA CATH PACK, Model Number DYNJ62007A;  ii)\tIR PACK, Model Number DYNJ62037D;  jj)\tAV FISTULA PACK, Model Number DYNJ62733A;  kk)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ63060B;  ll)\tCATH PACK, Model Number DYNJ63181A;  mm)\tCATH PACK, Model Number DYNJ63181B;  nn)\tCATH PACK, Model Number DYNJ63181C;  oo)\tCATH ANGIO PACK, Model Number DYNJ64050A;  pp)\tANGIOPLASTY PACK-LF, Model Number DYNJ64655C;  qq)\tIR GENERAL PACK, Model Number DYNJ64976;  rr)\tHEART TAVR PACK, Model Number DYNJ65174D;  ss)\tANGIOGRAPHY PACK, Model Number DYNJ65190D;  tt)\tANGIOGRAPHY PACK, Model Number DYNJ65190F;  uu)\tPACK,CARDIAC CATH, Model Number DYNJ65481;  vv)\tRADIOFREQUENCY ABLATION PACK, Model Number DYNJ65913;  ww)\tCATH LAB PACK, Model Number DYNJ66166A;  xx)\tCATH I W SPLIT DRAPE PACK, Model Number DYNJ66182;  yy)\tPORT A CATH INSERT PK, Model Number DYNJ66257;  zz)\tPORT A CATH INSERT PK, Model Number DYNJ66257A;  aaa)\tPORT A CATH INSERT PK, Model Number DYNJ66257B;  bbb)\tFISTULAGRAM PACK, Model Number DYNJ66259A;  ccc)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260A;  ddd)\tCATH PACK, Model Number DYNJ66473A;  eee)\tANGIOGRAPHY PACK, Model Number DYNJ66476A;  fff)\tFEMORAL PACK, Model Number DYNJ66515A;  ggg)\tIR PACK UNION, Model Number DYNJ66926A;  hhh)\tSTANDARD ANGIO TRAY MV, Model Number DYNJ67136A;  iii)\tANGIOGRAPHY PACK, Model Number DYNJ67144A;  jjj)\tDRAINAGE PROCEDURE PACK, Model Number DYNJ67149A;  kkk)\tCARDIAC CATH PACK, Model Number DYNJ67174A;  lll)\tCARDIAC CATH PACK, Model Number DYNJ67174B;  mmm)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245A;  nnn)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245B;  ooo)\tANGIOGRAPHIC TRAY, Model Number DYNJ67320A;  ppp)\tIR PACK, Model Number DYNJ67737;  qqq)\tTUNNEL LINE PACK, Model Number DYNJ67990A;  rrr)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065B;  sss)\tNEURO RADIOLOGY RICHMOND, Model Number DYNJ68365B;  ttt)\tIR PACK, Model Number DYNJ68538;  uuu)\tSPECIAL PROCEDURE CATH LAB PK, Model Number DYNJ68729;  vvv)\tIR PACK, Model Number DYNJ68729B;  www)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763;  xxx)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763A;  yyy)\tIR RADIOLOGY PACK, Model Number DYNJ69056;  zzz)\tIR RADIOLOGY PACK, Model Number DYNJ69056A;  aaaa)\tANGIO PACK, Model Number DYNJ69200;  bbbb)\tHGH TAVI PACK, Model Number DYNJ69298;  cccc)\tANGIO TRAY, Model Number DYNJ69421;  dddd)\tENDOV",
      "text": "The FDA logged enforcement record Z-2161-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY PACK, Model Number DYNJ55252C;  b)\tCATH LAB PACK, Model Number DYNJ55455A;  c)\tCATH LAB 2, Model Number DYNJ55680A;  d)\tIR ANGIO TRAY, Model Number DYNJ56038A;  e)\tCATH PACK, Model Number DYNJ56547C;  f)\tHYBRID, Model Number DYNJ57049G;  g)\tHYBRID, Model Number DYNJ57049I;  h)\tHYBRID, Model Number DYNJ57049J;  i)\tPERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C;  j)\tGENERAL ANGIO PACK, Model Number DYNJ57760C;  k)\tENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C;  l)\tANGIO PACK, Model Number DYNJ58111D;  m)\tANGIO PACK, Model Number DYNJ58111F;  n)\tPORT PACK, Model Number DYNJ58162;  o)\tENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B;  p)\tPERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A;  q)\tOR ANGIO PACK, Model Number DYNJ59184B;  r)\tPORT A CATH PACK, Model Number DYNJ59307F;  s)\tCATH PACK, Model Number DYNJ59632D;  t)\tPACK PERCUTANEOUS ANGIO  CHRG, Model Number DYNJ60112B;  u)\tI.R. PACK, Model Number DYNJ60343B;  v)\tI.R. PACK, Model Number DYNJ60343C;  w)\tCATH LAB PACK, Model Number DYNJ60763;  x)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082C;  y)\tCRMC ANGIOGRAM-LF, Model Number DYNJ61082D;  z)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099B;  aa)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099C;  bb)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118C;  cc)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118D;  dd)\tCRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118F;  ee)\tMAIN OR CATH LAB, Model Number DYNJ61373A;  ff)\tCARDIAC CATH PACK-LF, Model Number DYNJ61527A;  gg)\tIR PACK, Model Number DYNJ61646A;  hh)\tPERMA CATH PACK, Model Number DYNJ62007A;  ii)\tIR PACK, Model Number DYNJ62037D;  jj)\tAV FISTULA PACK, Model Number DYNJ62733A;  kk)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ63060B;  ll)\tCATH PACK, Model Number DYNJ63181A;  mm)\tCATH PACK, Model Number DYNJ63181B;  nn)\tCATH PACK, Model Number DYNJ63181C;  oo)\tCATH ANGIO PACK, Model Number DYNJ64050A;  pp)\tANGIOPLASTY PACK-LF, Model Number DYNJ64655C;  qq)\tIR GENERAL PACK, Model Number DYNJ64976;  rr)\tHEART TAVR PACK, Model Number DYNJ65174D;  ss)\tANGIOGRAPHY PACK, Model Number DYNJ65190D;  tt)\tANGIOGRAPHY PACK, Model Number DYNJ65190F;  uu)\tPACK,CARDIAC CATH, Model Number DYNJ65481;  vv)\tRADIOFREQUENCY ABLATION PACK, Model Number DYNJ65913;  ww)\tCATH LAB PACK, Model Number DYNJ66166A;  xx)\tCATH I W SPLIT DRAPE PACK, Model Number DYNJ66182;  yy)\tPORT A CATH INSERT PK, Model Number DYNJ66257;  zz)\tPORT A CATH INSERT PK, Model Number DYNJ66257A;  aaa)\tPORT A CATH INSERT PK, Model Number DYNJ66257B;  bbb)\tFISTULAGRAM PACK, Model Number DYNJ66259A;  ccc)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260A;  ddd)\tCATH PACK, Model Number DYNJ66473A;  eee)\tANGIOGRAPHY PACK, Model Number DYNJ66476A;  fff)\tFEMORAL PACK, Model Number DYNJ66515A;  ggg)\tIR PACK UNION, Model Number DYNJ66926A;  hhh)\tSTANDARD ANGIO TRAY MV, Model Number DYNJ67136A;  iii)\tANGIOGRAPHY PACK, Model Number DYNJ67144A;  jjj)\tDRAINAGE PROCEDURE PACK, Model Number DYNJ67149A;  kkk)\tCARDIAC CATH PACK, Model Number DYNJ67174A;  lll)\tCARDIAC CATH PACK, Model Number DYNJ67174B;  mmm)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245A;  nnn)\tOR ANGIOGRAPHY PACK, Model Number DYNJ67245B;  ooo)\tANGIOGRAPHIC TRAY, Model Number DYNJ67320A;  ppp)\tIR PACK, Model Number DYNJ67737;  qqq)\tTUNNEL LINE PACK, Model Number DYNJ67990A;  rrr)\tANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065B;  sss)\tNEURO RADIOLOGY RICHMOND, Model Number DYNJ68365B;  ttt)\tIR PACK, Model Number DYNJ68538;  uuu)\tSPECIAL PROCEDURE CATH LAB PK, Model Number DYNJ68729;  vvv)\tIR PACK, Model Number DYNJ68729B;  www)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763;  xxx)\tCATH LAB ANGIO TRAY, Model Number DYNJ68763A;  yyy)\tIR RADIOLOGY PACK, Model Number DYNJ69056;  zzz)\tIR RADIOLOGY PACK, Model Number DYNJ69056A;  aaaa)\tANGIO PACK, Model Number DYNJ69200;  bbbb)\tHGH TAVI PACK, Model Number DYNJ69298;  cccc)\tANGIO TRAY, Model Number DYNJ69421;  dddd)\tENDOV — 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 Number DYNJ55252C, UDI/DI (EA)10195327267919, UDI/DI (CS)40195327267910;  b) Model Number DYNJ55455A, UDI/DI (EA)10193489386233, UDI/DI (CS)40193489386234;  c) Model Number DYNJ55680A, UDI/DI (EA)10889942639786, UDI/DI (CS)40889942639787;  d) Model Number DYNJ56038A, UDI/DI (EA)10195327347840, UDI/DI (CS)40195327347841;  e) Model Number DYNJ56547C, UDI/DI (EA)10193489879834, UDI/DI (CS)40193489879835;  f) Model Number DYNJ57049G, UDI/DI (EA)10195327110390, UDI/DI (CS)40195327110391;  g) Model Number DYNJ57049I, UDI/DI (EA)10195327207731, UDI/DI (CS)40195327207732;  h) Model Number DYNJ57049J, UDI/DI (EA)10195327290658, UDI/DI (CS)40195327290659;  i) Model Number DYNJ57645C, UDI/DI (EA)10195327287412, UDI/DI (CS)40195327287413;  j) Model Number DYNJ57760C, UDI/DI (EA)10195327079390, UDI/DI (CS)40195327079391;  k) Model Number DYNJ57792C, UDI/DI (EA)10195327209902, UDI/DI (CS)40195327209903;  l) Model Number DYNJ58111D, UDI/DI (EA)10193489932928, UDI/DI (CS)40193489932929;  m) Model Number DYNJ58111F, UDI/DI (EA)10195327223519, UDI/DI (CS)40195327223510;  n) Model Number DYNJ58162, UDI/DI (EA)10889942829330, UDI/DI (CS)40889942829331;  o) Model Number DYNJ58178B, UDI/DI (EA)10195327209919, UDI/DI (CS)40195327209910;  p) Model Number DYNJ58510A, UDI/DI (EA)10193489817430, UDI/DI (CS)40193489817431;  q) Model Number DYNJ59184B, UDI/DI (EA)10193489949100, UDI/DI (CS)40193489949101;  r) Model Number DYNJ59307F, UDI/DI (EA)10195327058852, UDI/DI (CS)40195327058853;  s) Model Number DYNJ59632D, UDI/DI (EA)10195327034078, UDI/DI (CS)40195327034079;  t) Model Number DYNJ60112B, UDI/DI (EA)10195327118846, UDI/DI (CS)40195327118847;  u) Model Number DYNJ60343B, UDI/DI (EA)10195327215491, UDI/DI (CS)40195327215492;  v) Model Number DYNJ60343C, UDI/DI (EA)10195327285043, UDI/DI (CS)40195327285044;  w) Model Number DYNJ60763, UDI/DI (EA)10193489527964, UDI/DI (CS)40193489527965;  x) Model Number DYNJ61082C, UDI/DI (EA)10195327111410, UDI/DI (CS)40195327111411;  y) Model Number DYNJ61082D, UDI/DI (EA)10195327261993, UDI/DI (CS)40195327261994;  z) Model Number DYNJ61099B, UDI/DI (EA)10195327111854, UDI/DI (CS)40195327111855;  aa) Model Number DYNJ61099C, UDI/DI (EA)10195327262006, UDI/DI (CS)40195327262007;  bb) Model Number DYNJ61118C, UDI/DI (EA)10193489463972, UDI/DI (CS)40193489463973;  cc) Model Number DYNJ61118D, UDI/DI (EA)10195327108212, UDI/DI (CS)40195327108213;  dd) Model Number DYNJ61118F, UDI/DI (EA)10195327261986, UDI/DI (CS)40195327261987;  ee) Model Number DYNJ61373A, UDI/DI (EA)10195327014698, UDI/DI (CS)40195327014699;  ff) Model Number DYNJ61527A, UDI/DI (EA)10195327383800, UDI/DI (CS)40195327383801;  gg) Model Number DYNJ61646A, UDI/DI (EA)10195327014315, UDI/DI (CS)40195327014316;  hh) Model Number DYNJ62007A, UDI/DI (EA)10193489878905, UDI/DI (CS)40193489878906;  ii) Model Number DYNJ62037D, UDI/DI (EA)10193489893694, UDI/DI (CS)40193489893695;  jj) Model Number DYNJ62733A, UDI/DI (EA)10193489970678, UDI/DI (CS)40193489970679;  kk) Model Number DYNJ63060B, UDI/DI (EA)10193489912821, UDI/DI (CS)40193489912822;  ll) Model Number DYNJ63181A, UDI/DI (EA)10195327045487, UDI/DI (CS)40195327045488;  mm) Model Number DYNJ63181B, UDI/DI (EA)10195327127213, UDI/DI (CS)40195327127214;  nn) Model Number DYNJ63181C, UDI/DI (EA)10195327242008, UDI/DI (CS)40195327242009;  oo) Model Number DYNJ64050A, UDI/DI (EA)10193489943825, UDI/DI (CS)40193489943826;  pp) Model Number DYNJ64655C, UDI/DI (EA)10195327172893, UDI/DI (CS)40195327172894;  qq) Model Number DYNJ64976, UDI/DI (EA)10193489237122, UDI/DI (CS)40193489237123;  rr) Model Number DYNJ65174D, UDI/DI (EA)10193489962154, UDI/DI (CS)40193489962155;  ss) Model Number DYNJ65190D, UDI/DI (EA)10195327066642, UDI/DI (CS)40195327066643;  tt) Model Number DYNJ65190F, UDI/DI (EA)10195327092658, UDI/DI (CS)40195327092659;  uu) Model Number DYNJ65481, UDI/DI (EA)10193489280463, UDI/DI (CS)40193489280464;  vv) Model Number DYNJ65913, UDI/DI (EA)10193489303179, UDI/DI (CS)40193489303170;  ww) Model Number DYNJ66166A, UDI/DI (EA)10193489395990, UDI/DI (CS)40193489395991;  xx) Model Number DYNJ66182, UDI/DI (EA)10193489320985, UDI/DI (CS)40193489320986;  yy) Model Number DYNJ66257, UDI/DI (EA)10193489325492, UDI/DI (CS)40193489325493;  zz) Model Number DYNJ66257A, UDI/DI (EA)10193489947502, UDI/DI (CS)40193489947503;  aaa) Model Number DYNJ66257B, UDI/DI (EA)10195327185831, UDI/DI (CS)40195327185832;  bbb) Model Number DYNJ66259A, UDI/DI (EA)10195327185732, UDI/DI (CS)40195327185733;  ccc) Model Number DYNJ66260A, UDI/DI (EA)10195327185749, UDI/DI (CS)40195327185740;  ddd) Model Number DYNJ66473A, UDI/DI (EA)10193489917772, UDI/DI (CS)40193489917773;  eee) Model Number DYNJ66476A, UDI/DI (EA)10195327051891, UDI/DI (CS)40195327051892;  fff) Model Number DYNJ66515A, UDI/DI (EA)10193489406160, UDI/DI (CS)40193489406161;  ggg) Model Number DYNJ66926A, UDI/DI (EA)10193489887358, UDI/DI (CS)40193489887359;  hhh) Model Number DYNJ67136A, UDI/DI (EA)10193489935677, UDI/DI (CS)40193489935678;  iii) Model Number DYNJ67144A, UDI/DI (EA)10195327179021, UDI/DI (CS)40195327179022;  jjj) Model Number DYNJ67149A, UDI/DI (EA)10195327179038, UDI/DI (CS)40195327179039;  kkk) Model Number DYNJ67174A, UDI/DI (EA)10195327046804, UDI/DI (CS)40195327046805;  lll) Model Number DYNJ67174B, UDI/DI (EA)10195327131081, UDI/DI (CS)40195327131082;  mmm) Model Number DYNJ67245A, UDI/DI (EA)10195327024253, UDI/DI (CS)40195327024254;  nnn) Model Number DYNJ67245B, UDI/DI (EA)10195327292225, UDI/DI (CS)40195327292226;  ooo) Model Number DYNJ67320A, UDI/DI (EA)10193489937572, UDI/DI (CS)40193489937573;  ppp) Model Number DYNJ67737, UDI/DI (EA)10193489427752, UDI/DI (CS)40193489427753;  qqq) Model Number DYNJ67990A, UDI/DI (EA)10195327265335, UDI/DI (CS)40195327265336;  rrr) Model Number DYNJ68065B, UDI/DI (EA)10195327013332, UDI/DI (CS)40195327013333;  sss) Model Number DYNJ68365B, UDI/DI (EA)10195327161934, UDI/DI (CS)40195327161935;  ttt) Model Number DYNJ68538, UDI/DI (EA)10193489833119, UDI/DI (CS)40193489833110;  uuu) Model Number DYNJ68729, UDI/DI (EA)10193489836547, UDI/DI (CS)40193489836548;  vvv) Model Number DYNJ68729B, UDI/DI (EA)10195327020910, UDI/DI (CS)40195327020911;  www) Model Number DYNJ68763, UDI/DI (EA)10193489837599, UDI/DI (CS)40193489837590;  xxx) Model Number DYNJ68763A, UDI/DI (EA)10195327264789, UDI/DI (CS)40195327264780;  yyy) Model Number DYNJ69056, UDI/DI (EA)10193489886870, UDI/DI (CS)40193489886871;  zzz) Model Number DYNJ69056A, UDI/DI (EA)10195327061296, UDI/DI (CS)40195327061297;  aaaa) Model Number DYNJ69200, UDI/DI (EA)10193489906813, UDI/DI (CS)40193489906814;  bbbb) Model Number DYNJ69298, UDI/DI (EA)10193489925418, UDI/DI (CS)40193489925419;  cccc) Model Number DYNJ69421, UDI/DI (EA)10193489937596, UDI/DI (CS)40193489937597;  dddd) Model Number DYNJ69691, UDI/DI (EA)10193489970111, UDI/DI (CS)40193489970112;  eeee) Model Number DYNJ69742B, UDI/DI (EA)10195327136888, UDI/DI (CS)40195327136889;  ffff) Model Number DYNJ69763A, UDI/DI (EA)10195327330019, UDI/DI (CS)40195327330010;  gggg) Model Number DYNJ69864, UDI/DI (EA)10193489990485, UDI/DI (CS)40193489990486;  hhhh) Model Number DYNJ69944, UDI/DI (EA)10193489998450, UDI/DI (CS)40193489998451;  iiii) Model Number DYNJ69944A, UDI/DI (EA)10195327285364, UDI/DI (CS)40195327285365;  jjjj) Model Number DYNJ69951, UDI/DI (EA)10195327000301, UDI/DI (CS)40195327000302;  kkkk) Model Number DYNJ80269, UDI/DI (EA)10195327017804, UDI/DI (CS)40195327017805;  llll) Model Number DYNJ80297, UDI/DI (EA)10195327021771, UDI/DI (CS)40195327021772;  mmmm) Model Number DYNJ80297A, UDI/DI (EA)10195327372170, UDI/DI (CS)40195327372171;  nnnn) Model Number DYNJ81213, UDI/DI (EA)10195327094270, UDI/DI (CS)40195327094271;  oooo) Model Number DYNJ81213A, UDI/DI (EA)10195327319250, UDI/DI (CS)40195327319251;  pppp) Model Number DYNJ81316, UDI/DI (EA)10195327103798, UDI/DI (CS)40195327103799;  qqqq) Model Number DYNJ81429A, UDI/DI (EA)10195327321642, UDI/DI (CS)40195327321643;  rrrr) Model Number DYNJ81435B, UDI/DI (EA)10195327324834, UDI/DI (CS)40195327324835;  ssss) Model Number DYNJ82030, UDI/DI (EA)10195327162375, UDI/DI (CS)40195327162376;  tttt) Model Number DYNJ82041, UDI/DI (EA)10195327162214, UDI/DI (CS)40195327162215;  uuuu) Model Number DYNJ82079, UDI/DI (EA)10195327167363, UDI/DI (CS)40195327167364;  vvvv) Model Number DYNJ82280, UDI/DI (EA)10195327183929, UDI/DI (CS)40195327183920;  wwww) Model Number DYNJ82296, UDI/DI (EA)10195327184209, UDI/DI (CS)40195327184200;  xxxx) Model Number DYNJ82999, UDI/DI (EA)10195327223106, UDI/DI (CS)40195327223107;  yyyy) Model Number DYNJ82999A, UDI/DI (EA)10195327310271, UDI/DI (CS)40195327310272;  zzzz)   Model Number DYNJ83089, UDI/DI (EA)10195327230838, UDI/DI (CS)40195327230839;. 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-2161-2023&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-2161-2023&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-2161-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2161-2023 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-2161-2023&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-2161-2023&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-2161-2023/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": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2161-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2161-2023",
            "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"
          }
        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
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 uuu) Model Number DYNJ68729, UDI/DI (EA)10193489836547, UDI/DI (CS)40193489836548;  vvv) Model Number DYNJ68729B, UDI/DI (EA)10195327020910, UDI/DI (CS)40195327020911;  www) Model Number DYNJ68763, UDI/DI (EA)10193489837599, UDI/DI (CS)40193489837590;  xxx) Model Number DYNJ68763A, UDI/DI (EA)10195327264789, UDI/DI (CS)40195327264780;  yyy) Model Number DYNJ69056, UDI/DI (EA)10193489886870, UDI/DI (CS)40193489886871;  zzz) Model Number DYNJ69056A, UDI/DI (EA)10195327061296, UDI/DI (CS)40195327061297;  aaaa) Model Number DYNJ69200, UDI/DI (EA)10193489906813, UDI/DI (CS)40193489906814;  bbbb) Model Number DYNJ69298, UDI/DI (EA)10193489925418, UDI/DI (CS)40193489925419;  cccc) Model Number DYNJ69421, UDI/DI (EA)10193489937596, UDI/DI (CS)40193489937597;  dddd) Model Number DYNJ69691, UDI/DI (EA)10193489970111, UDI/DI (CS)40193489970112;  eeee) Model Number DYNJ69742B, UDI/DI (EA)10195327136888, UDI/DI (CS)40195327136889;  ffff) Model Number DYNJ69763A, UDI/DI (EA)10195327330019, UDI/DI (CS)40195327330010;  gggg) Model Number DYNJ69864, UDI/DI (EA)10193489990485, UDI/DI (CS)40193489990486;  hhhh) Model Number DYNJ69944, UDI/DI (EA)10193489998450, UDI/DI (CS)40193489998451;  iiii) Model Number DYNJ69944A, UDI/DI (EA)10195327285364, UDI/DI (CS)40195327285365;  jjjj) Model Number DYNJ69951, UDI/DI (EA)10195327000301, UDI/DI (CS)40195327000302;  kkkk) Model Number DYNJ80269, UDI/DI (EA)10195327017804, UDI/DI (CS)40195327017805;  llll) Model Number DYNJ80297, UDI/DI (EA)10195327021771, UDI/DI (CS)40195327021772;  mmmm) Model Number DYNJ80297A, UDI/DI (EA)10195327372170, UDI/DI (CS)40195327372171;  nnnn) Model Number DYNJ81213, UDI/DI (EA)10195327094270, UDI/DI (CS)40195327094271;  oooo) Model Number DYNJ81213A, UDI/DI (EA)10195327319250, UDI/DI (CS)40195327319251;  pppp) Model Number DYNJ81316, UDI/DI (EA)10195327103798, UDI/DI (CS)40195327103799;  qqqq) Model Number DYNJ81429A, UDI/DI (EA)10195327321642, UDI/DI (CS)40195327321643;  rrrr) Model Number DYNJ81435B, UDI/DI (EA)10195327324834, UDI/DI (CS)40195327324835; 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            "Status": "recorded"
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        },
        {
          "@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"
          }
        }
      ]
    }
  ]
}