{
  "@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-2180-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tVEIN KIT, Model Number DYNJ55841B;  b)\tFACELIFT PACK, Model Number DYNJ55954B;  c)\tCLOT RETRIEVAL PACK, Model Number DYNJ56140B;  d)\tVENOUS PACK, Model Number DYNJ56260B;  e)\tWMC ULTRASOUND PACK, Model Number DYNJ56392;  f)\tWMC ULTRASOUND PACK, Model Number DYNJ56392A;  g)\tWMC ULTRASOUND PACK, Model Number DYNJ56392B;  h)\tULTRASOUND KIT-LF, Model Number DYNJ56507B;  i)\tEVLT PACK, Model Number DYNJ56548B;  j)\tRFA PACK, Model Number DYNJ57149;  k)\tSPECIALS TRACE PACK, Model Number DYNJ57303B;  l)\tCLOSURE PACK, Model Number DYNJ57514;  m)\tEP PACK, Model Number DYNJ57594A;  n)\tVEIN TRAY, Model Number DYNJ57736A;  o)\tENSEMBLE PICC LINE-LF, Model Number DYNJ57793;  p)\tPICC LINE PACK-LF, Model Number DYNJ58160;  q)\tENDOVENOUS PACK, Model Number DYNJ58228;  r)\tBIB AV FISTULA PACK, Model Number DYNJ58304;  s)\tTRIPLE P KIT, Model Number DYNJ58424;  t)\tLINQ TRAY, Model Number DYNJ58643A;  u)\tTUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062;  v)\tPICC PROCEDURE PACK, Model Number DYNJ59067;  w)\tENDOVASCULAR PACK, Model Number DYNJ59085;  x)\tVEIN CLOSURE PACK, Model Number DYNJ59094;  y)\tCLOSURE PROCEDURE, Model Number DYNJ59206;  z)\tVNUS PACK, Model Number DYNJ59246;  aa)\tDESERT CARDIOVASCULAR PACK, Model Number DYNJ59377;  bb)\tEP LAB, Model Number DYNJ59392C;  cc)\tVEIN PACK-LF, Model Number DYNJ59631;  dd)\tPROCEDURE PACK, Model Number DYNJ59795A;  ee)\tPACK ENDO AAA HYBRID  CHRG, Model Number DYNJ60126A;  ff)\tKF PACK, Model Number DYNJ60127A;  gg)\tVENASEAL PACK, Model Number DYNJ60128A;  hh)\tI.R. PACK, Model Number DYNJ60343A;  ii)\tCLOSURE PACK, Model Number DYNJ60804;  jj)\tCLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067;  kk)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A;  ll)\tECMO PACK, Model Number DYNJ61243;  mm)\tVEIN PACK, Model Number DYNJ61264;  nn)\tUNIVERSAL PACK, Model Number DYNJ61433;  oo)\tOCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517;  pp)\tENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295;  qq)\tENS. CHIMIO  EMBOLISATION-LF, Model Number DYNJ62295A;  rr)\tENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B;  ss)\tSCLEROTHERAPY KIT, Model Number DYNJ62434A;  tt)\tABLATION PACK, Model Number DYNJ62540;  uu)\tPROCEDURE PACK, Model Number DYNJ62588;  vv)\tVEIN ABLATION, Model Number DYNJ63268B;  ww)\tTF TAVR PACK, Model Number DYNJ63340;  xx)\tAFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C;  yy)\tALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A;  zz)\tNIR PACK, Model Number DYNJ63892;  aaa)\tABLATION PACK, Model Number DYNJ64068;  bbb)\tLASER KIT, Model Number DYNJ64075A;  ccc)\tEVLT, Model Number DYNJ64336;  ddd)\tPROCEDURE PACK, Model Number DYNJ64372A;  eee)\tPREMIER PROCEDURE PACK, Model Number DYNJ64393;  fff)\tMINOR SET UP PACK, Model Number DYNJ64439;  ggg)\tVIP PACK, Model Number DYNJ64666A;  hhh)\tCT ABLATION PACK, Model Number DYNJ64928A;  iii)\tULTRASOUND KIT, Model Number DYNJ64930;  jjj)\tVEIN CLOSURE PACK, Model Number DYNJ65189C;  kkk)\tPACK,LTD  BODY SSP, Model Number DYNJ65488B;  lll)\tEVLT PACK, Model Number DYNJ65995;  mmm)\tEVLT PACK, Model Number DYNJ65995A;  nnn)\tEVLT PACK, Model Number DYNJ66005;  ooo)\tJVL-PACK TUNNELED, Model Number DYNJ66065;  ppp)\tEVLA PACK, Model Number DYNJ66258;  qqq)\tEVLA PACK, Model Number DYNJ66258A;  rrr)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260;  sss)\tIR PACKER, Model Number DYNJ66620A;  ttt)\tCLOSURE PROCEDURE PACK, Model Number DYNJ66741;  uuu)\tPHYSIATRY PACK, Model Number DYNJ67414;  vvv)\tFEM POP PACK, Model Number DYNJ67487A;  www)\tSPECIALS PACK, Model Number DYNJ67504A;  xxx)\tSPECIALS PACK, Model Number DYNJ67504B;  yyy)\tRFA PACK, Model Number DYNJ67899;  zzz)\tRR-BRACHY PACK, Model Number DYNJ68027;  aaaa)\tCOPS PROCEDURE PACK-LF, Model Number DYNJ68923A;  bbbb)\tPROCEDURE PACK, Model Number DYNJ68968;  cccc)\tPORT PACK, Model Number DYNJ68990;  dddd)\tACCESS PACK, Model Number DYNJ69017;  eeee)\tKF PACK 2.0, Model Number DYNJ69619;  ffff)\tNLK BASIC PACK, Model Number DYNJ69716A;  gg",
  "description": "FDA recall Z-2180-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tVEIN KIT, Model Number DYNJ55841B;  b)\tFACELIFT PACK, Model Number DYNJ55954B;  c)\tCLOT RETRIEVAL PACK, Model Number DYNJ56140B;  d)\tVENOUS PACK, Model Number DYNJ56260B;  e)\tWMC ULTRASOUND PACK, Model Number DYNJ56392;  f)\tWMC ULTRASOUND PACK, Model Number DYNJ56392A;  g)\tWMC ULTRASOUND PACK, Model Number DYNJ56392B;  h)\tULTRASOUND KIT-LF, Model Number DYNJ56507B;  i)\tEVLT PACK, Model Number DYNJ56548B;  j)\tRFA PACK, Model Number DYNJ57149;  k)\tSPECIALS TRACE PACK, Model Number DYNJ57303B;  l)\tCLOSURE PACK, Model Number DYNJ57514;  m)\tEP PACK, Model Number DYNJ57594A;  n)\tVEIN TRAY, Model Number DYNJ57736A;  o)\tENSEMBLE PICC LINE-LF, Model Number DYNJ57793;  p)\tPICC LINE PACK-LF, Model Number DYNJ58160;  q)\tENDOVENOUS PACK, Model Number DYNJ58228;  r)\tBIB AV FISTULA PACK, Model Number DYNJ58304;  s)\tTRIPLE P KIT, Model Number DYNJ58424;  t)\tLINQ TRAY, Model Number DYNJ58643A;  u)\tTUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062;  v)\tPICC PROCEDURE PACK, Model Number DYNJ59067;  w)\tENDOVASCULAR PACK, Model Number DYNJ59085;  x)\tVEIN CLOSURE PACK, Model Number DYNJ59094;  y)\tCLOSURE PROCEDURE, Model Number DYNJ59206;  z)\tVNUS PACK, Model Number DYNJ59246;  aa)\tDESERT CARDIOVASCULAR PACK, Model Number DYNJ59377;  bb)\tEP LAB, Model Number DYNJ59392C;  cc)\tVEIN PACK-LF, Model Number DYNJ59631;  dd)\tPROCEDURE PACK, Model Number DYNJ59795A;  ee)\tPACK ENDO AAA HYBRID  CHRG, Model Number DYNJ60126A;  ff)\tKF PACK, Model Number DYNJ60127A;  gg)\tVENASEAL PACK, Model Number DYNJ60128A;  hh)\tI.R. PACK, Model Number DYNJ60343A;  ii)\tCLOSURE PACK, Model Number DYNJ60804;  jj)\tCLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067;  kk)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A;  ll)\tECMO PACK, Model Number DYNJ61243;  mm)\tVEIN PACK, Model Number DYNJ61264;  nn)\tUNIVERSAL PACK, Model Number DYNJ61433;  oo)\tOCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517;  pp)\tENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295;  qq)\tENS. CHIMIO  EMBOLISATION-LF, Model Number DYNJ62295A;  rr)\tENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B;  ss)\tSCLEROTHERAPY KIT, Model Number DYNJ62434A;  tt)\tABLATION PACK, Model Number DYNJ62540;  uu)\tPROCEDURE PACK, Model Number DYNJ62588;  vv)\tVEIN ABLATION, Model Number DYNJ63268B;  ww)\tTF TAVR PACK, Model Number DYNJ63340;  xx)\tAFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C;  yy)\tALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A;  zz)\tNIR PACK, Model Number DYNJ63892;  aaa)\tABLATION PACK, Model Number DYNJ64068;  bbb)\tLASER KIT, Model Number DYNJ64075A;  ccc)\tEVLT, Model Number DYNJ64336;  ddd)\tPROCEDURE PACK, Model Number DYNJ64372A;  eee)\tPREMIER PROCEDURE PACK, Model Number DYNJ64393;  fff)\tMINOR SET UP PACK, Model Number DYNJ64439;  ggg)\tVIP PACK, Model Number DYNJ64666A;  hhh)\tCT ABLATION PACK, Model Number DYNJ64928A;  iii)\tULTRASOUND KIT, Model Number DYNJ64930;  jjj)\tVEIN CLOSURE PACK, Model Number DYNJ65189C;  kkk)\tPACK,LTD  BODY SSP, Model Number DYNJ65488B;  lll)\tEVLT PACK, Model Number DYNJ65995;  mmm)\tEVLT PACK, Model Number DYNJ65995A;  nnn)\tEVLT PACK, Model Number DYNJ66005;  ooo)\tJVL-PACK TUNNELED, Model Number DYNJ66065;  ppp)\tEVLA PACK, Model Number DYNJ66258;  qqq)\tEVLA PACK, Model Number DYNJ66258A;  rrr)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260;  sss)\tIR PACKER, Model Number DYNJ66620A;  ttt)\tCLOSURE PROCEDURE PACK, Model Number DYNJ66741;  uuu)\tPHYSIATRY PACK, Model Number DYNJ67414;  vvv)\tFEM POP PACK, Model Number DYNJ67487A;  www)\tSPECIALS PACK, Model Number DYNJ67504A;  xxx)\tSPECIALS PACK, Model Number DYNJ67504B;  yyy)\tRFA PACK, Model Number DYNJ67899;  zzz)\tRR-BRACHY PACK, Model Number DYNJ68027;  aaaa)\tCOPS PROCEDURE PACK-LF, Model Number DYNJ68923A;  bbbb)\tPROCEDURE PACK, Model Number DYNJ68968;  cccc)\tPORT PACK, Model Number DYNJ68990;  dddd)\tACCESS PACK, Model Number DYNJ69017;  eeee)\tKF PACK 2.0, Model Number DYNJ69619;  ffff)\tNLK BASIC PACK, Model Number DYNJ69716A;  gg (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-2180-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tVEIN KIT, Model Number DYNJ55841B;  b)\tFACELIFT PACK, Model Number DYNJ55954B;  c)\tCLOT RETRIEVAL PACK, Model Number DYNJ56140B;  d)\tVENOUS PACK, Model Number DYNJ56260B;  e)\tWMC ULTRASOUND PACK, Model Number DYNJ56392;  f)\tWMC ULTRASOUND PACK, Model Number DYNJ56392A;  g)\tWMC ULTRASOUND PACK, Model Number DYNJ56392B;  h)\tULTRASOUND KIT-LF, Model Number DYNJ56507B;  i)\tEVLT PACK, Model Number DYNJ56548B;  j)\tRFA PACK, Model Number DYNJ57149;  k)\tSPECIALS TRACE PACK, Model Number DYNJ57303B;  l)\tCLOSURE PACK, Model Number DYNJ57514;  m)\tEP PACK, Model Number DYNJ57594A;  n)\tVEIN TRAY, Model Number DYNJ57736A;  o)\tENSEMBLE PICC LINE-LF, Model Number DYNJ57793;  p)\tPICC LINE PACK-LF, Model Number DYNJ58160;  q)\tENDOVENOUS PACK, Model Number DYNJ58228;  r)\tBIB AV FISTULA PACK, Model Number DYNJ58304;  s)\tTRIPLE P KIT, Model Number DYNJ58424;  t)\tLINQ TRAY, Model Number DYNJ58643A;  u)\tTUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062;  v)\tPICC PROCEDURE PACK, Model Number DYNJ59067;  w)\tENDOVASCULAR PACK, Model Number DYNJ59085;  x)\tVEIN CLOSURE PACK, Model Number DYNJ59094;  y)\tCLOSURE PROCEDURE, Model Number DYNJ59206;  z)\tVNUS PACK, Model Number DYNJ59246;  aa)\tDESERT CARDIOVASCULAR PACK, Model Number DYNJ59377;  bb)\tEP LAB, Model Number DYNJ59392C;  cc)\tVEIN PACK-LF, Model Number DYNJ59631;  dd)\tPROCEDURE PACK, Model Number DYNJ59795A;  ee)\tPACK ENDO AAA HYBRID  CHRG, Model Number DYNJ60126A;  ff)\tKF PACK, Model Number DYNJ60127A;  gg)\tVENASEAL PACK, Model Number DYNJ60128A;  hh)\tI.R. PACK, Model Number DYNJ60343A;  ii)\tCLOSURE PACK, Model Number DYNJ60804;  jj)\tCLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067;  kk)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A;  ll)\tECMO PACK, Model Number DYNJ61243;  mm)\tVEIN PACK, Model Number DYNJ61264;  nn)\tUNIVERSAL PACK, Model Number DYNJ61433;  oo)\tOCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517;  pp)\tENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295;  qq)\tENS. CHIMIO  EMBOLISATION-LF, Model Number DYNJ62295A;  rr)\tENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B;  ss)\tSCLEROTHERAPY KIT, Model Number DYNJ62434A;  tt)\tABLATION PACK, Model Number DYNJ62540;  uu)\tPROCEDURE PACK, Model Number DYNJ62588;  vv)\tVEIN ABLATION, Model Number DYNJ63268B;  ww)\tTF TAVR PACK, Model Number DYNJ63340;  xx)\tAFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C;  yy)\tALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A;  zz)\tNIR PACK, Model Number DYNJ63892;  aaa)\tABLATION PACK, Model Number DYNJ64068;  bbb)\tLASER KIT, Model Number DYNJ64075A;  ccc)\tEVLT, Model Number DYNJ64336;  ddd)\tPROCEDURE PACK, Model Number DYNJ64372A;  eee)\tPREMIER PROCEDURE PACK, Model Number DYNJ64393;  fff)\tMINOR SET UP PACK, Model Number DYNJ64439;  ggg)\tVIP PACK, Model Number DYNJ64666A;  hhh)\tCT ABLATION PACK, Model Number DYNJ64928A;  iii)\tULTRASOUND KIT, Model Number DYNJ64930;  jjj)\tVEIN CLOSURE PACK, Model Number DYNJ65189C;  kkk)\tPACK,LTD  BODY SSP, Model Number DYNJ65488B;  lll)\tEVLT PACK, Model Number DYNJ65995;  mmm)\tEVLT PACK, Model Number DYNJ65995A;  nnn)\tEVLT PACK, Model Number DYNJ66005;  ooo)\tJVL-PACK TUNNELED, Model Number DYNJ66065;  ppp)\tEVLA PACK, Model Number DYNJ66258;  qqq)\tEVLA PACK, Model Number DYNJ66258A;  rrr)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260;  sss)\tIR PACKER, Model Number DYNJ66620A;  ttt)\tCLOSURE PROCEDURE PACK, Model Number DYNJ66741;  uuu)\tPHYSIATRY PACK, Model Number DYNJ67414;  vvv)\tFEM POP PACK, Model Number DYNJ67487A;  www)\tSPECIALS PACK, Model Number DYNJ67504A;  xxx)\tSPECIALS PACK, Model Number DYNJ67504B;  yyy)\tRFA PACK, Model Number DYNJ67899;  zzz)\tRR-BRACHY PACK, Model Number DYNJ68027;  aaaa)\tCOPS PROCEDURE PACK-LF, Model Number DYNJ68923A;  bbbb)\tPROCEDURE PACK, Model Number DYNJ68968;  cccc)\tPORT PACK, Model Number DYNJ68990;  dddd)\tACCESS PACK, Model Number DYNJ69017;  eeee)\tKF PACK 2.0, Model Number DYNJ69619;  ffff)\tNLK BASIC PACK, Model Number DYNJ69716A;  gg",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2180-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2180-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tVEIN KIT, Model Number DYNJ55841B;  b)\tFACELIFT PACK, Model Number DYNJ55954B;  c)\tCLOT RETRIEVAL PACK, Model Number DYNJ56140B;  d)\tVENOUS PACK, Model Number DYNJ56260B;  e)\tWMC ULTRASOUND PACK, Model Number DYNJ56392;  f)\tWMC ULTRASOUND PACK, Model Number DYNJ56392A;  g)\tWMC ULTRASOUND PACK, Model Number DYNJ56392B;  h)\tULTRASOUND KIT-LF, Model Number DYNJ56507B;  i)\tEVLT PACK, Model Number DYNJ56548B;  j)\tRFA PACK, Model Number DYNJ57149;  k)\tSPECIALS TRACE PACK, Model Number DYNJ57303B;  l)\tCLOSURE PACK, Model Number DYNJ57514;  m)\tEP PACK, Model Number DYNJ57594A;  n)\tVEIN TRAY, Model Number DYNJ57736A;  o)\tENSEMBLE PICC LINE-LF, Model Number DYNJ57793;  p)\tPICC LINE PACK-LF, Model Number DYNJ58160;  q)\tENDOVENOUS PACK, Model Number DYNJ58228;  r)\tBIB AV FISTULA PACK, Model Number DYNJ58304;  s)\tTRIPLE P KIT, Model Number DYNJ58424;  t)\tLINQ TRAY, Model Number DYNJ58643A;  u)\tTUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062;  v)\tPICC PROCEDURE PACK, Model Number DYNJ59067;  w)\tENDOVASCULAR PACK, Model Number DYNJ59085;  x)\tVEIN CLOSURE PACK, Model Number DYNJ59094;  y)\tCLOSURE PROCEDURE, Model Number DYNJ59206;  z)\tVNUS PACK, Model Number DYNJ59246;  aa)\tDESERT CARDIOVASCULAR PACK, Model Number DYNJ59377;  bb)\tEP LAB, Model Number DYNJ59392C;  cc)\tVEIN PACK-LF, Model Number DYNJ59631;  dd)\tPROCEDURE PACK, Model Number DYNJ59795A;  ee)\tPACK ENDO AAA HYBRID  CHRG, Model Number DYNJ60126A;  ff)\tKF PACK, Model Number DYNJ60127A;  gg)\tVENASEAL PACK, Model Number DYNJ60128A;  hh)\tI.R. PACK, Model Number DYNJ60343A;  ii)\tCLOSURE PACK, Model Number DYNJ60804;  jj)\tCLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067;  kk)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A;  ll)\tECMO PACK, Model Number DYNJ61243;  mm)\tVEIN PACK, Model Number DYNJ61264;  nn)\tUNIVERSAL PACK, Model Number DYNJ61433;  oo)\tOCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517;  pp)\tENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295;  qq)\tENS. CHIMIO  EMBOLISATION-LF, Model Number DYNJ62295A;  rr)\tENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B;  ss)\tSCLEROTHERAPY KIT, Model Number DYNJ62434A;  tt)\tABLATION PACK, Model Number DYNJ62540;  uu)\tPROCEDURE PACK, Model Number DYNJ62588;  vv)\tVEIN ABLATION, Model Number DYNJ63268B;  ww)\tTF TAVR PACK, Model Number DYNJ63340;  xx)\tAFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C;  yy)\tALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A;  zz)\tNIR PACK, Model Number DYNJ63892;  aaa)\tABLATION PACK, Model Number DYNJ64068;  bbb)\tLASER KIT, Model Number DYNJ64075A;  ccc)\tEVLT, Model Number DYNJ64336;  ddd)\tPROCEDURE PACK, Model Number DYNJ64372A;  eee)\tPREMIER PROCEDURE PACK, Model Number DYNJ64393;  fff)\tMINOR SET UP PACK, Model Number DYNJ64439;  ggg)\tVIP PACK, Model Number DYNJ64666A;  hhh)\tCT ABLATION PACK, Model Number DYNJ64928A;  iii)\tULTRASOUND KIT, Model Number DYNJ64930;  jjj)\tVEIN CLOSURE PACK, Model Number DYNJ65189C;  kkk)\tPACK,LTD  BODY SSP, Model Number DYNJ65488B;  lll)\tEVLT PACK, Model Number DYNJ65995;  mmm)\tEVLT PACK, Model Number DYNJ65995A;  nnn)\tEVLT PACK, Model Number DYNJ66005;  ooo)\tJVL-PACK TUNNELED, Model Number DYNJ66065;  ppp)\tEVLA PACK, Model Number DYNJ66258;  qqq)\tEVLA PACK, Model Number DYNJ66258A;  rrr)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260;  sss)\tIR PACKER, Model Number DYNJ66620A;  ttt)\tCLOSURE PROCEDURE PACK, Model Number DYNJ66741;  uuu)\tPHYSIATRY PACK, Model Number DYNJ67414;  vvv)\tFEM POP PACK, Model Number DYNJ67487A;  www)\tSPECIALS PACK, Model Number DYNJ67504A;  xxx)\tSPECIALS PACK, Model Number DYNJ67504B;  yyy)\tRFA PACK, Model Number DYNJ67899;  zzz)\tRR-BRACHY PACK, Model Number DYNJ68027;  aaaa)\tCOPS PROCEDURE PACK-LF, Model Number DYNJ68923A;  bbbb)\tPROCEDURE PACK, Model Number DYNJ68968;  cccc)\tPORT PACK, Model Number DYNJ68990;  dddd)\tACCESS PACK, Model Number DYNJ69017;  eeee)\tKF PACK 2.0, Model Number DYNJ69619;  ffff)\tNLK BASIC PACK, Model Number DYNJ69716A;  gg",
      "text": "The FDA logged enforcement record Z-2180-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tVEIN KIT, Model Number DYNJ55841B;  b)\tFACELIFT PACK, Model Number DYNJ55954B;  c)\tCLOT RETRIEVAL PACK, Model Number DYNJ56140B;  d)\tVENOUS PACK, Model Number DYNJ56260B;  e)\tWMC ULTRASOUND PACK, Model Number DYNJ56392;  f)\tWMC ULTRASOUND PACK, Model Number DYNJ56392A;  g)\tWMC ULTRASOUND PACK, Model Number DYNJ56392B;  h)\tULTRASOUND KIT-LF, Model Number DYNJ56507B;  i)\tEVLT PACK, Model Number DYNJ56548B;  j)\tRFA PACK, Model Number DYNJ57149;  k)\tSPECIALS TRACE PACK, Model Number DYNJ57303B;  l)\tCLOSURE PACK, Model Number DYNJ57514;  m)\tEP PACK, Model Number DYNJ57594A;  n)\tVEIN TRAY, Model Number DYNJ57736A;  o)\tENSEMBLE PICC LINE-LF, Model Number DYNJ57793;  p)\tPICC LINE PACK-LF, Model Number DYNJ58160;  q)\tENDOVENOUS PACK, Model Number DYNJ58228;  r)\tBIB AV FISTULA PACK, Model Number DYNJ58304;  s)\tTRIPLE P KIT, Model Number DYNJ58424;  t)\tLINQ TRAY, Model Number DYNJ58643A;  u)\tTUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062;  v)\tPICC PROCEDURE PACK, Model Number DYNJ59067;  w)\tENDOVASCULAR PACK, Model Number DYNJ59085;  x)\tVEIN CLOSURE PACK, Model Number DYNJ59094;  y)\tCLOSURE PROCEDURE, Model Number DYNJ59206;  z)\tVNUS PACK, Model Number DYNJ59246;  aa)\tDESERT CARDIOVASCULAR PACK, Model Number DYNJ59377;  bb)\tEP LAB, Model Number DYNJ59392C;  cc)\tVEIN PACK-LF, Model Number DYNJ59631;  dd)\tPROCEDURE PACK, Model Number DYNJ59795A;  ee)\tPACK ENDO AAA HYBRID  CHRG, Model Number DYNJ60126A;  ff)\tKF PACK, Model Number DYNJ60127A;  gg)\tVENASEAL PACK, Model Number DYNJ60128A;  hh)\tI.R. PACK, Model Number DYNJ60343A;  ii)\tCLOSURE PACK, Model Number DYNJ60804;  jj)\tCLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067;  kk)\tCRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A;  ll)\tECMO PACK, Model Number DYNJ61243;  mm)\tVEIN PACK, Model Number DYNJ61264;  nn)\tUNIVERSAL PACK, Model Number DYNJ61433;  oo)\tOCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517;  pp)\tENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295;  qq)\tENS. CHIMIO  EMBOLISATION-LF, Model Number DYNJ62295A;  rr)\tENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B;  ss)\tSCLEROTHERAPY KIT, Model Number DYNJ62434A;  tt)\tABLATION PACK, Model Number DYNJ62540;  uu)\tPROCEDURE PACK, Model Number DYNJ62588;  vv)\tVEIN ABLATION, Model Number DYNJ63268B;  ww)\tTF TAVR PACK, Model Number DYNJ63340;  xx)\tAFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C;  yy)\tALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A;  zz)\tNIR PACK, Model Number DYNJ63892;  aaa)\tABLATION PACK, Model Number DYNJ64068;  bbb)\tLASER KIT, Model Number DYNJ64075A;  ccc)\tEVLT, Model Number DYNJ64336;  ddd)\tPROCEDURE PACK, Model Number DYNJ64372A;  eee)\tPREMIER PROCEDURE PACK, Model Number DYNJ64393;  fff)\tMINOR SET UP PACK, Model Number DYNJ64439;  ggg)\tVIP PACK, Model Number DYNJ64666A;  hhh)\tCT ABLATION PACK, Model Number DYNJ64928A;  iii)\tULTRASOUND KIT, Model Number DYNJ64930;  jjj)\tVEIN CLOSURE PACK, Model Number DYNJ65189C;  kkk)\tPACK,LTD  BODY SSP, Model Number DYNJ65488B;  lll)\tEVLT PACK, Model Number DYNJ65995;  mmm)\tEVLT PACK, Model Number DYNJ65995A;  nnn)\tEVLT PACK, Model Number DYNJ66005;  ooo)\tJVL-PACK TUNNELED, Model Number DYNJ66065;  ppp)\tEVLA PACK, Model Number DYNJ66258;  qqq)\tEVLA PACK, Model Number DYNJ66258A;  rrr)\tANGIOGRAM SET UP PACK, Model Number DYNJ66260;  sss)\tIR PACKER, Model Number DYNJ66620A;  ttt)\tCLOSURE PROCEDURE PACK, Model Number DYNJ66741;  uuu)\tPHYSIATRY PACK, Model Number DYNJ67414;  vvv)\tFEM POP PACK, Model Number DYNJ67487A;  www)\tSPECIALS PACK, Model Number DYNJ67504A;  xxx)\tSPECIALS PACK, Model Number DYNJ67504B;  yyy)\tRFA PACK, Model Number DYNJ67899;  zzz)\tRR-BRACHY PACK, Model Number DYNJ68027;  aaaa)\tCOPS PROCEDURE PACK-LF, Model Number DYNJ68923A;  bbbb)\tPROCEDURE PACK, Model Number DYNJ68968;  cccc)\tPORT PACK, Model Number DYNJ68990;  dddd)\tACCESS PACK, Model Number DYNJ69017;  eeee)\tKF PACK 2.0, Model Number DYNJ69619;  ffff)\tNLK BASIC PACK, Model Number DYNJ69716A;  gg — 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 DYNJ55841B, UDI/DI (EA) 10888277757684, UDI/DI (CS) 40888277757685;  b) Model Number DYNJ55954B, UDI/DI (EA) 10193489214239, UDI/DI (CS) 40193489214230;  c) Model Number DYNJ56140B, UDI/DI (EA) 10193489547672, UDI/DI (CS) 40193489547673;  d) Model Number DYNJ56260B, UDI/DI (EA) 10193489569827, UDI/DI (CS) 40193489569828;  e) Model Number DYNJ56392, UDI/DI (EA) 10889942640676, UDI/DI (CS) 40889942640677;  f) Model Number DYNJ56392A, UDI/DI (EA) 10195327261405, UDI/DI (CS) 40195327261406;  g) Model Number DYNJ56392B, UDI/DI (EA) 10195327323677, UDI/DI (CS) 40195327323678;  h) Model Number DYNJ56507B, UDI/DI (EA) 10193489443479, UDI/DI (CS) 40193489443470;  i) Model Number DYNJ56548B, UDI/DI (EA) 10193489813180, UDI/DI (CS) 40193489813181;  j) Model Number DYNJ57149, UDI/DI (EA) 10889942721603, UDI/DI (CS) 40889942721604;  k) Model Number DYNJ57303B, UDI/DI (EA) 10193489360646, UDI/DI (CS) 40193489360647;  l) Model Number DYNJ57514, UDI/DI (EA) 10889942747849, UDI/DI (CS) 40889942747840;  m) Model Number DYNJ57594A, UDI/DI (EA) 10889942963218, UDI/DI (CS) 40889942963219;  n) Model Number DYNJ57736A, UDI/DI (EA) 10888277779709, UDI/DI (CS) 40888277779700;  o) Model Number DYNJ57793, UDI/DI (EA) 10889942819164, UDI/DI (CS) 40889942819165;  p) Model Number DYNJ58160, UDI/DI (EA) 10889942828647, UDI/DI (CS) 40889942828648;  q) Model Number DYNJ58228, UDI/DI (EA) 10889942835492, UDI/DI (CS) 40889942835493;  r) Model Number DYNJ58304, UDI/DI (EA) 10889942843732, UDI/DI (CS) 40889942843733;  s) Model Number DYNJ58424, UDI/DI (EA) 10889942851836, UDI/DI (CS) 40889942851837;  t) Model Number DYNJ58643A, UDI/DI (EA) 10193489809213, UDI/DI (CS) 40193489809214;  u) Model Number DYNJ59062, UDI/DI (EA) 10889942941650, UDI/DI (CS) 40889942941651;  v) Model Number DYNJ59067, UDI/DI (EA) 10889942930043, UDI/DI (CS) 40889942930044;  w) Model Number DYNJ59085, UDI/DI (EA) 10889942932016, UDI/DI (CS) 40889942932017;  x) Model Number DYNJ59094, UDI/DI (EA) 10889942933501, UDI/DI (CS) 40889942933502;  y) Model Number DYNJ59206, UDI/DI (EA) 10888277765573, UDI/DI (CS) 40888277765574;  z) Model Number DYNJ59246, UDI/DI (EA) 10888277767294, UDI/DI (CS) 40888277767295;  aa) Model Number DYNJ59377, UDI/DI (EA) 10888277736290, UDI/DI (CS) 40888277736291;  bb) Model Number DYNJ59392C, UDI/DI (EA) 10193489282245, UDI/DI (CS) 40193489282246;  cc) Model Number DYNJ59631, UDI/DI (EA) 10888277764026, UDI/DI (CS) 40888277764027;  dd) Model Number DYNJ59795A, UDI/DI (EA) 10193489566987, UDI/DI (CS) 40193489566988;  ee) Model Number DYNJ60126A, UDI/DI (EA) 10193489247084, UDI/DI (CS) 40193489247085;  ff) Model Number DYNJ60127A, UDI/DI (EA) 10193489729047, UDI/DI (CS) 40193489729048;  gg) Model Number DYNJ60128A, UDI/DI (EA) 10193489544510, UDI/DI (CS) 40193489544511;  hh) Model Number DYNJ60343A, UDI/DI (EA) 10193489573831, UDI/DI (CS) 40193489573832;  ii) Model Number DYNJ60804, UDI/DI (EA) 10193489532784, UDI/DI (CS) 40193489532785;  jj) Model Number DYNJ61067, UDI/DI (EA) 10193489542226, UDI/DI (CS) 40193489542227;  kk) Model Number DYNJ61099A, UDI/DI (EA) 10193489463965, UDI/DI (CS) 40193489463966;  ll) Model Number DYNJ61243, UDI/DI (EA) 10193489550917, UDI/DI (CS) 40193489550918;  mm) Model Number DYNJ61264, UDI/DI (EA) 10193489554472, UDI/DI (CS) 40193489554473;  nn) Model Number DYNJ61433, UDI/DI (EA) 10193489565171, UDI/DI (CS) 40193489565172;  oo) Model Number DYNJ61517, UDI/DI (EA) 10193489577570, UDI/DI (CS) 40193489577571;  pp) Model Number DYNJ62295, UDI/DI (EA) 10193489641165, UDI/DI (CS) 40193489641166;  qq) Model Number DYNJ62295A, UDI/DI (EA) 10193489845952, UDI/DI (CS) 40193489845953;  rr) Model Number DYNJ62295B, UDI/DI (EA) 10195327209933, UDI/DI (CS) 40195327209934;  ss) Model Number DYNJ62434A, UDI/DI (EA) 10193489366273, UDI/DI (CS) 40193489366274;  tt) Model Number DYNJ62540, UDI/DI (EA) 10193489666472, UDI/DI (CS) 40193489666473;  uu) Model Number DYNJ62588, UDI/DI (EA) 10193489669831, UDI/DI (CS) 40193489669832;  vv) Model Number DYNJ63268B, UDI/DI (EA) 10193489305111, UDI/DI (CS) 40193489305112;  ww) Model Number DYNJ63340, UDI/DI (EA) 10193489741162, UDI/DI (CS) 40193489741163;  xx) Model Number DYNJ63354C, UDI/DI (EA) 10195327273255, UDI/DI (CS) 40195327273256;  yy) Model Number DYNJ63576A, UDI/DI (EA) 10193489429251, UDI/DI (CS) 40193489429252;  zz) Model Number DYNJ63892, UDI/DI (EA) 10193489771435, UDI/DI (CS) 40193489771436;  aaa) Model Number DYNJ64068, UDI/DI (EA) 10193489783131, UDI/DI (CS) 40193489783132;  bbb) Model Number DYNJ64075A, UDI/DI (EA) 10193489231328, UDI/DI (CS) 40193489231329;  ccc) Model Number DYNJ64336, UDI/DI (EA) 10193489801873, UDI/DI (CS) 40193489801874;  ddd) Model Number DYNJ64372A, UDI/DI (EA) 10193489884685, UDI/DI (CS) 40193489884686;  eee) Model Number DYNJ64393, UDI/DI (EA) 10193489809633, UDI/DI (CS) 40193489809634;  fff) Model Number DYNJ64439, UDI/DI (EA) 10193489200485, UDI/DI (CS) 40193489200486;  ggg) Model Number DYNJ64666A, UDI/DI (EA) 10193489317268, UDI/DI (CS) 40193489317269;  hhh) Model Number DYNJ64928A, UDI/DI (EA) 10195327329815, UDI/DI (CS) 40195327329816;  iii) Model Number DYNJ64930, UDI/DI (EA) 10193489231687, UDI/DI (CS) 40193489231688;  jjj) Model Number DYNJ65189C, UDI/DI (EA) 10195327072001, UDI/DI (CS) 40195327072002;  kkk) Model Number DYNJ65488B, UDI/DI (EA) 10193489443646, UDI/DI (CS) 40193489443647;  lll) Model Number DYNJ65995, UDI/DI (EA) 10193489311549, UDI/DI (CS) 40193489311540;  mmm) Model Number DYNJ65995A, UDI/DI (EA) 10195327068127, UDI/DI (CS) 40195327068128;  nnn) Model Number DYNJ66005, UDI/DI (EA) 10193489312546, UDI/DI (CS) 40193489312547;  ooo) Model Number DYNJ66065, UDI/DI (EA) 10193489319187, UDI/DI (CS) 40193489319188;  ppp) Model Number DYNJ66258, UDI/DI (EA) 10193489325478, UDI/DI (CS) 40193489325479;  qqq) Model Number DYNJ66258A, UDI/DI (EA) 10195327194239, UDI/DI (CS) 40195327194230;  rrr) Model Number DYNJ66260, UDI/DI (EA) 10193489325461, UDI/DI (CS) 40193489325462;  sss) Model Number DYNJ66620A, UDI/DI (EA) 10193489914245, UDI/DI (CS) 40193489914246;  ttt) Model Number DYNJ66741, UDI/DI (EA) 10193489374940, UDI/DI (CS) 40193489374941;  uuu) Model Number DYNJ67414, UDI/DI (EA) 10193489964646, UDI/DI (CS) 40193489964647;  vvv) Model Number DYNJ67487A, UDI/DI (EA) 10193489888997, UDI/DI (CS) 40193489888998;  www) Model Number DYNJ67504A, UDI/DI (EA) 10195327009618, UDI/DI (CS) 40195327009619;  xxx) Model Number DYNJ67504B, UDI/DI (EA) 10195327331023, UDI/DI (CS) 40195327331024;  yyy) Model Number DYNJ67899, UDI/DI (EA) 10193489454499, UDI/DI (CS) 40193489454490;  zzz) Model Number DYNJ68027, UDI/DI (EA) 10193489469158, UDI/DI (CS) 40193489469159;  aaaa) Model Number DYNJ68923A, UDI/DI (EA) 10195327070793, UDI/DI (CS) 40195327070794;  bbbb) Model Number DYNJ68968, UDI/DI (EA) 10193489870398, UDI/DI (CS) 40193489870399;  cccc) Model Number DYNJ68990, UDI/DI (EA) 10193489872613, UDI/DI (CS) 40193489872614;  dddd) Model Number DYNJ69017, UDI/DI (EA) 10193489878158, UDI/DI (CS) 40193489878159;  eeee) Model Number DYNJ69619, UDI/DI (EA) 10193489959444, UDI/DI (CS) 40193489959445;  ffff) Model Number DYNJ69716A, UDI/DI (EA) 10195327250577, UDI/DI (CS) 40195327250578;  gggg) Model Number DYNJ69820, UDI/DI (EA) 10193489981438, UDI/DI (CS) 40193489981439;  hhhh) Model Number DYNJ80299, UDI/DI (EA) 10195327021931, UDI/DI (CS) 40195327021932;  iiii) Model Number DYNJ81343, UDI/DI (EA) 10195327113063, UDI/DI (CS) 40195327113064;  jjjj) Model Number DYNJ83152, UDI/DI (EA) 10195327237080, UDI/DI (CS) 40195327237081;  kkkk) Model Number DYNJ83524, UDI/DI (EA) 10195327273491, UDI/DI (CS) 40195327273492;  llll) Model Number DYNJ83931, UDI/DI (EA) 10195327315351, UDI/DI (CS) 40195327315352;  mmmm) Model Number DYNJ83976, UDI/DI (EA) 10195327323196, UDI/DI (CS) 40195327323197;  nnnn) Model Number DYNJ84172, UDI/DI (EA) 10195327338909, UDI/DI (CS) 40195327338900;  oooo) Model Number DYNJ901348D, UDI/DI (EA) 10193489594683, UDI/DI (CS) 40193489594684;  pppp) Model Number DYNJ901392D, UDI/DI (EA) 10193489539516, UDI/DI (CS) 40193489539517;  qqqq) Model Number DYNJ902168D, UDI/DI (EA) 10193489866155, UDI/DI (CS) 40193489866156;  rrrr) Model Number DYNJ902281, UDI/DI (EA) 10888277981416, UDI/DI (CS) 40888277981417;  ssss) Model Number DYNJ905002A, UDI/DI (EA) 10889942911653, UDI/DI (CS) 40889942911654;  tttt) Model Number DYNJ905335, UDI/DI (EA) 10889942875894, UDI/DI (CS) 40889942875895;  uuuu) Model Number DYNJ905651B, UDI/DI (EA) 10193489925067, UDI/DI (CS) 40193489925068;  vvvv) Model Number DYNJ905936B, UDI/DI (EA) 10193489422818, UDI/DI (CS) 40193489422819;  wwww) Model Number DYNJ908752, UDI/DI (EA) 10195327171360, UDI/DI (CS) 40195327171361;  xxxx) Model Number DYNJRA0585, UDI/DI (EA) 10888277580695, UDI/DI (CS) 40888277580696;  yyyy) Model Number DYNJRA1155B, UDI/DI (EA) 10193489583717, UDI/DI (CS) 40193489583718;  zzzz) Model Number DYNJRA1578, UDI/DI (EA) 10193489272789, UDI/DI (CS) 40193489272780;. 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-2180-2023&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-2180-2023&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-2180-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2180-2023 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-2180-2023&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-2180-2023&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-2180-2023/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-2180-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2180-2023",
            "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",
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 jj) Model Number DYNJ61067, UDI/DI (EA) 10193489542226, UDI/DI (CS) 40193489542227;  kk) Model Number DYNJ61099A, UDI/DI (EA) 10193489463965, UDI/DI (CS) 40193489463966;  ll) Model Number DYNJ61243, UDI/DI (EA) 10193489550917, UDI/DI (CS) 40193489550918;  mm) Model Number DYNJ61264, UDI/DI (EA) 10193489554472, UDI/DI (CS) 40193489554473;  nn) Model Number DYNJ61433, UDI/DI (EA) 10193489565171, UDI/DI (CS) 40193489565172;  oo) Model Number DYNJ61517, UDI/DI (EA) 10193489577570, UDI/DI (CS) 40193489577571;  pp) Model Number DYNJ62295, UDI/DI (EA) 10193489641165, UDI/DI (CS) 40193489641166;  qq) Model Number DYNJ62295A, UDI/DI (EA) 10193489845952, UDI/DI (CS) 40193489845953;  rr) Model Number DYNJ62295B, UDI/DI (EA) 10195327209933, UDI/DI (CS) 40195327209934;  ss) Model Number DYNJ62434A, UDI/DI (EA) 10193489366273, UDI/DI (CS) 40193489366274;  tt) Model Number DYNJ62540, UDI/DI (EA) 10193489666472, UDI/DI (CS) 40193489666473;  uu) Model Number DYNJ62588, UDI/DI (EA) 10193489669831, UDI/DI (CS) 40193489669832; 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 ttt) Model Number DYNJ66741, UDI/DI (EA) 10193489374940, UDI/DI (CS) 40193489374941;  uuu) Model Number DYNJ67414, UDI/DI (EA) 10193489964646, UDI/DI (CS) 40193489964647;  vvv) Model Number DYNJ67487A, UDI/DI (EA) 10193489888997, UDI/DI (CS) 40193489888998;  www) Model Number DYNJ67504A, UDI/DI (EA) 10195327009618, UDI/DI (CS) 40195327009619;  xxx) Model Number DYNJ67504B, UDI/DI (EA) 10195327331023, UDI/DI (CS) 40195327331024;  yyy) Model Number DYNJ67899, UDI/DI (EA) 10193489454499, UDI/DI (CS) 40193489454490;  zzz) Model Number DYNJ68027, UDI/DI (EA) 10193489469158, UDI/DI (CS) 40193489469159;  aaaa) Model Number DYNJ68923A, UDI/DI (EA) 10195327070793, UDI/DI (CS) 40195327070794;  bbbb) Model Number DYNJ68968, UDI/DI (EA) 10193489870398, UDI/DI (CS) 40193489870399;  cccc) Model Number DYNJ68990, UDI/DI (EA) 10193489872613, UDI/DI (CS) 40193489872614;  dddd) Model Number DYNJ69017, UDI/DI (EA) 10193489878158, UDI/DI (CS) 40193489878159;  eeee) Model Number DYNJ69619, UDI/DI (EA) 10193489959444, UDI/DI (CS) 40193489959445; 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            "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"
          }
        }
      ]
    }
  ]
}