{
  "@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-2199-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tFEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005;   b)\t20GX6\" FEMORAL ART LINE KIT, Model Number ART1165;   c)\t3\" RADIAL ARTERIAL LINE KIT, Model Number ART240A;   d)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245A;   e)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245B;   f)\tARTERIAL LINE BUNDLE, Model Number ART255;   g)\tARTERIAL LINE BUNDLE, Model Number ART560;   h)\tA LINE TRAY, Model Number ART690;   i)\tARTERIAL LINE TRAY, Model Number ART840;   j)\t18GX6\" FEMORAL ART LINE KIT, Model Number ART960;   k)\t20Gx3\" RADIAL ART LINE KIT, Model Number ART970;   l)\tBIOPSY/ASPIRATION TRAY, Model Number BT235A;   m)\tPERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825;   n)\tPICC INSERTION KIT, Model Number CVI3735;   o)\tPICC INSERTION BUNDLE, Model Number CVI4025A;   p)\tVASCULAR ACCESS  INSERTION KIT, Model Number CVI4180;   q)\tVASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265;   r)\tUNIVERSAL CVC ZONE DEFENSE BUNDLE, Model Number CVI4430;   s)\tPEDIATRIC PICC INSERTION TRAY, Model Number CVI4450A;   t)\tCVC ACCESSORY BUNDLE, Model Number CVI4505;   u)\tDIALYSIS/CVC BUNDLE W/O CATHETER, Model Number CVI4655;   v)\tFISHLINE KIT, Model Number CVI4725;   w)\tVENOUS ACCESS TRAY, Model Number CVI4830A;   x)\tVENOUS ACCESS TRAY, Model Number CVI4830B;   y)\tCVC INSERTION BUNDLE- ADD A CATHETER, Model Number CVI4905;   z)\tMVHS CVC LUMEN TRAY, Model Number CVI4920;   aa)\tART LINE SECUREMENT KIT W/LIDOCAINE, Model Number DT22570A;   bb)\tADULT VASCULAR ACCESS BUNDLE, Model Number DT22860;   cc)\tTOTE MCADAMS OSC SHLDR ARTHRO, Model Number DYKM1790A;   dd)\tMAX BARRIER KIT, Model Number DYND2673B;   ee)\tTHYROID FNA TRAY, Model Number DYNDA2238A;   ff)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;   gg)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   hh)\tULTRASOUND BIOPSY, Model Number DYNDH1542;   ii)\tBIOPSY TRAY, Model Number DYNDH1661;   jj)\tUSG PIV KIT, Model Number DYNDV2536A;   kk)\tULTRASOUND IV ACCESS PACK - LF, Model Number DYNJ0182378B;   ll)\tPORT INSERTION KIT, Model Number MNS11590;   mm)\tRADIOLOGY TRAY, Model Number MNS11625;   nn)\tBEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number MNS12065;   oo)\tINTRA PROBE COVER 5X96 KIT, Model Number P155598;   pp)\tULTRASOUND PROBE KIT, Model Number P482986;   qq)\tARTHROGRAM TRAY, Model Number SPEC0232;   rr)\tULTRA CORE BIOPSY KIT, Model Number SPEC0291B;",
  "description": "FDA recall Z-2199-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tFEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005;   b)\t20GX6\" FEMORAL ART LINE KIT, Model Number ART1165;   c)\t3\" RADIAL ARTERIAL LINE KIT, Model Number ART240A;   d)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245A;   e)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245B;   f)\tARTERIAL LINE BUNDLE, Model Number ART255;   g)\tARTERIAL LINE BUNDLE, Model Number ART560;   h)\tA LINE TRAY, Model Number ART690;   i)\tARTERIAL LINE TRAY, Model Number ART840;   j)\t18GX6\" FEMORAL ART LINE KIT, Model Number ART960;   k)\t20Gx3\" RADIAL ART LINE KIT, Model Number ART970;   l)\tBIOPSY/ASPIRATION TRAY, Model Number BT235A;   m)\tPERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825;   n)\tPICC INSERTION KIT, Model Number CVI3735;   o)\tPICC INSERTION BUNDLE, Model Number CVI4025A;   p)\tVASCULAR ACCESS  INSERTION KIT, Model Number CVI4180;   q)\tVASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265;   r)\tUNIVERSAL CVC ZONE DEFENSE BUNDLE, Model Number CVI4430;   s)\tPEDIATRIC PICC INSERTION TRAY, Model Number CVI4450A;   t)\tCVC ACCESSORY BUNDLE, Model Number CVI4505;   u)\tDIALYSIS/CVC BUNDLE W/O CATHETER, Model Number CVI4655;   v)\tFISHLINE KIT, Model Number CVI4725;   w)\tVENOUS ACCESS TRAY, Model Number CVI4830A;   x)\tVENOUS ACCESS TRAY, Model Number CVI4830B;   y)\tCVC INSERTION BUNDLE- ADD A CATHETER, Model Number CVI4905;   z)\tMVHS CVC LUMEN TRAY, Model Number CVI4920;   aa)\tART LINE SECUREMENT KIT W/LIDOCAINE, Model Number DT22570A;   bb)\tADULT VASCULAR ACCESS BUNDLE, Model Number DT22860;   cc)\tTOTE MCADAMS OSC SHLDR ARTHRO, Model Number DYKM1790A;   dd)\tMAX BARRIER KIT, Model Number DYND2673B;   ee)\tTHYROID FNA TRAY, Model Number DYNDA2238A;   ff)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;   gg)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   hh)\tULTRASOUND BIOPSY, Model Number DYNDH1542;   ii)\tBIOPSY TRAY, Model Number DYNDH1661;   jj)\tUSG PIV KIT, Model Number DYNDV2536A;   kk)\tULTRASOUND IV ACCESS PACK - LF, Model Number DYNJ0182378B;   ll)\tPORT INSERTION KIT, Model Number MNS11590;   mm)\tRADIOLOGY TRAY, Model Number MNS11625;   nn)\tBEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number MNS12065;   oo)\tINTRA PROBE COVER 5X96 KIT, Model Number P155598;   pp)\tULTRASOUND PROBE KIT, Model Number P482986;   qq)\tARTHROGRAM TRAY, Model Number SPEC0232;   rr)\tULTRA CORE BIOPSY KIT, Model Number SPEC0291B; (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-2199-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tFEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005;   b)\t20GX6\" FEMORAL ART LINE KIT, Model Number ART1165;   c)\t3\" RADIAL ARTERIAL LINE KIT, Model Number ART240A;   d)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245A;   e)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245B;   f)\tARTERIAL LINE BUNDLE, Model Number ART255;   g)\tARTERIAL LINE BUNDLE, Model Number ART560;   h)\tA LINE TRAY, Model Number ART690;   i)\tARTERIAL LINE TRAY, Model Number ART840;   j)\t18GX6\" FEMORAL ART LINE KIT, Model Number ART960;   k)\t20Gx3\" RADIAL ART LINE KIT, Model Number ART970;   l)\tBIOPSY/ASPIRATION TRAY, Model Number BT235A;   m)\tPERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825;   n)\tPICC INSERTION KIT, Model Number CVI3735;   o)\tPICC INSERTION BUNDLE, Model Number CVI4025A;   p)\tVASCULAR ACCESS  INSERTION KIT, Model Number CVI4180;   q)\tVASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265;   r)\tUNIVERSAL CVC ZONE DEFENSE BUNDLE, Model Number CVI4430;   s)\tPEDIATRIC PICC INSERTION TRAY, Model Number CVI4450A;   t)\tCVC ACCESSORY BUNDLE, Model Number CVI4505;   u)\tDIALYSIS/CVC BUNDLE W/O CATHETER, Model Number CVI4655;   v)\tFISHLINE KIT, Model Number CVI4725;   w)\tVENOUS ACCESS TRAY, Model Number CVI4830A;   x)\tVENOUS ACCESS TRAY, Model Number CVI4830B;   y)\tCVC INSERTION BUNDLE- ADD A CATHETER, Model Number CVI4905;   z)\tMVHS CVC LUMEN TRAY, Model Number CVI4920;   aa)\tART LINE SECUREMENT KIT W/LIDOCAINE, Model Number DT22570A;   bb)\tADULT VASCULAR ACCESS BUNDLE, Model Number DT22860;   cc)\tTOTE MCADAMS OSC SHLDR ARTHRO, Model Number DYKM1790A;   dd)\tMAX BARRIER KIT, Model Number DYND2673B;   ee)\tTHYROID FNA TRAY, Model Number DYNDA2238A;   ff)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;   gg)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   hh)\tULTRASOUND BIOPSY, Model Number DYNDH1542;   ii)\tBIOPSY TRAY, Model Number DYNDH1661;   jj)\tUSG PIV KIT, Model Number DYNDV2536A;   kk)\tULTRASOUND IV ACCESS PACK - LF, Model Number DYNJ0182378B;   ll)\tPORT INSERTION KIT, Model Number MNS11590;   mm)\tRADIOLOGY TRAY, Model Number MNS11625;   nn)\tBEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number MNS12065;   oo)\tINTRA PROBE COVER 5X96 KIT, Model Number P155598;   pp)\tULTRASOUND PROBE KIT, Model Number P482986;   qq)\tARTHROGRAM TRAY, Model Number SPEC0232;   rr)\tULTRA CORE BIOPSY KIT, Model Number SPEC0291B;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2199-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2199-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tFEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005;   b)\t20GX6\" FEMORAL ART LINE KIT, Model Number ART1165;   c)\t3\" RADIAL ARTERIAL LINE KIT, Model Number ART240A;   d)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245A;   e)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245B;   f)\tARTERIAL LINE BUNDLE, Model Number ART255;   g)\tARTERIAL LINE BUNDLE, Model Number ART560;   h)\tA LINE TRAY, Model Number ART690;   i)\tARTERIAL LINE TRAY, Model Number ART840;   j)\t18GX6\" FEMORAL ART LINE KIT, Model Number ART960;   k)\t20Gx3\" RADIAL ART LINE KIT, Model Number ART970;   l)\tBIOPSY/ASPIRATION TRAY, Model Number BT235A;   m)\tPERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825;   n)\tPICC INSERTION KIT, Model Number CVI3735;   o)\tPICC INSERTION BUNDLE, Model Number CVI4025A;   p)\tVASCULAR ACCESS  INSERTION KIT, Model Number CVI4180;   q)\tVASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265;   r)\tUNIVERSAL CVC ZONE DEFENSE BUNDLE, Model Number CVI4430;   s)\tPEDIATRIC PICC INSERTION TRAY, Model Number CVI4450A;   t)\tCVC ACCESSORY BUNDLE, Model Number CVI4505;   u)\tDIALYSIS/CVC BUNDLE W/O CATHETER, Model Number CVI4655;   v)\tFISHLINE KIT, Model Number CVI4725;   w)\tVENOUS ACCESS TRAY, Model Number CVI4830A;   x)\tVENOUS ACCESS TRAY, Model Number CVI4830B;   y)\tCVC INSERTION BUNDLE- ADD A CATHETER, Model Number CVI4905;   z)\tMVHS CVC LUMEN TRAY, Model Number CVI4920;   aa)\tART LINE SECUREMENT KIT W/LIDOCAINE, Model Number DT22570A;   bb)\tADULT VASCULAR ACCESS BUNDLE, Model Number DT22860;   cc)\tTOTE MCADAMS OSC SHLDR ARTHRO, Model Number DYKM1790A;   dd)\tMAX BARRIER KIT, Model Number DYND2673B;   ee)\tTHYROID FNA TRAY, Model Number DYNDA2238A;   ff)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;   gg)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   hh)\tULTRASOUND BIOPSY, Model Number DYNDH1542;   ii)\tBIOPSY TRAY, Model Number DYNDH1661;   jj)\tUSG PIV KIT, Model Number DYNDV2536A;   kk)\tULTRASOUND IV ACCESS PACK - LF, Model Number DYNJ0182378B;   ll)\tPORT INSERTION KIT, Model Number MNS11590;   mm)\tRADIOLOGY TRAY, Model Number MNS11625;   nn)\tBEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number MNS12065;   oo)\tINTRA PROBE COVER 5X96 KIT, Model Number P155598;   pp)\tULTRASOUND PROBE KIT, Model Number P482986;   qq)\tARTHROGRAM TRAY, Model Number SPEC0232;   rr)\tULTRA CORE BIOPSY KIT, Model Number SPEC0291B;",
      "text": "The FDA logged enforcement record Z-2199-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tFEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005;   b)\t20GX6\" FEMORAL ART LINE KIT, Model Number ART1165;   c)\t3\" RADIAL ARTERIAL LINE KIT, Model Number ART240A;   d)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245A;   e)\t6\" FEMORAL ARTERIAL  LINE KIT, Model Number ART245B;   f)\tARTERIAL LINE BUNDLE, Model Number ART255;   g)\tARTERIAL LINE BUNDLE, Model Number ART560;   h)\tA LINE TRAY, Model Number ART690;   i)\tARTERIAL LINE TRAY, Model Number ART840;   j)\t18GX6\" FEMORAL ART LINE KIT, Model Number ART960;   k)\t20Gx3\" RADIAL ART LINE KIT, Model Number ART970;   l)\tBIOPSY/ASPIRATION TRAY, Model Number BT235A;   m)\tPERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825;   n)\tPICC INSERTION KIT, Model Number CVI3735;   o)\tPICC INSERTION BUNDLE, Model Number CVI4025A;   p)\tVASCULAR ACCESS  INSERTION KIT, Model Number CVI4180;   q)\tVASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265;   r)\tUNIVERSAL CVC ZONE DEFENSE BUNDLE, Model Number CVI4430;   s)\tPEDIATRIC PICC INSERTION TRAY, Model Number CVI4450A;   t)\tCVC ACCESSORY BUNDLE, Model Number CVI4505;   u)\tDIALYSIS/CVC BUNDLE W/O CATHETER, Model Number CVI4655;   v)\tFISHLINE KIT, Model Number CVI4725;   w)\tVENOUS ACCESS TRAY, Model Number CVI4830A;   x)\tVENOUS ACCESS TRAY, Model Number CVI4830B;   y)\tCVC INSERTION BUNDLE- ADD A CATHETER, Model Number CVI4905;   z)\tMVHS CVC LUMEN TRAY, Model Number CVI4920;   aa)\tART LINE SECUREMENT KIT W/LIDOCAINE, Model Number DT22570A;   bb)\tADULT VASCULAR ACCESS BUNDLE, Model Number DT22860;   cc)\tTOTE MCADAMS OSC SHLDR ARTHRO, Model Number DYKM1790A;   dd)\tMAX BARRIER KIT, Model Number DYND2673B;   ee)\tTHYROID FNA TRAY, Model Number DYNDA2238A;   ff)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;   gg)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   hh)\tULTRASOUND BIOPSY, Model Number DYNDH1542;   ii)\tBIOPSY TRAY, Model Number DYNDH1661;   jj)\tUSG PIV KIT, Model Number DYNDV2536A;   kk)\tULTRASOUND IV ACCESS PACK - LF, Model Number DYNJ0182378B;   ll)\tPORT INSERTION KIT, Model Number MNS11590;   mm)\tRADIOLOGY TRAY, Model Number MNS11625;   nn)\tBEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number MNS12065;   oo)\tINTRA PROBE COVER 5X96 KIT, Model Number P155598;   pp)\tULTRASOUND PROBE KIT, Model Number P482986;   qq)\tARTHROGRAM TRAY, Model Number SPEC0232;   rr)\tULTRA CORE BIOPSY KIT, Model Number SPEC0291B; — 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 ART1005, UDI/DI (EA) 10193489198232, UDI/DI (CS) 20193489198239;  b) Model Number ART1165, UDI/DI (EA) 10653160354680, UDI/DI (CS) 00653160354683;  c) Model Number ART240A, UDI/DI (EA) 10653160328025, UDI/DI (CS) 00653160328028;  d) Model Number ART245A, UDI/DI (EA) 10653160328018, UDI/DI (CS) 00653160328011;  e) Model Number ART245B, UDI/DI (EA) 10653160358442, UDI/DI (CS) 00653160358445;  f) Model Number ART255, UDI/DI (EA) 10653160311997, UDI/DI (CS) 00653160311990;  g) Model Number ART560, UDI/DI (EA) 10653160310822, UDI/DI (CS) 00653160310825;  h) Model Number ART690, UDI/DI (EA) 10653160318019, UDI/DI (CS) 00653160318012;  i) Model Number ART840, UDI/DI (EA) 10653160322924, UDI/DI (CS) 00653160322927;  j) Model Number ART960, UDI/DI (EA) 10193489190915, UDI/DI (CS) 20193489190912;  k) Model Number ART970, UDI/DI (EA) 10193489190922, UDI/DI (CS) 20193489190929;  l) Model Number BT235A, UDI/DI (EA) 10653160315919, UDI/DI (CS) 00653160315912;  m) Model Number CHT1825, UDI/DI (EA) 10653160328988, UDI/DI (CS) 00653160328981;  n) Model Number CVI3735, UDI/DI (EA) 10653160261544, UDI/DI (CS) 00653160261547;  o) Model Number CVI4025A, UDI/DI (EA) 10193489396058, UDI/DI (CS) 40193489396059;  p) Model Number CVI4180, UDI/DI (EA) 10653160284451, UDI/DI (CS) 00653160284454;  q) Model Number CVI4265, UDI/DI (EA) 10653160291268, UDI/DI (CS) 00653160291261;  r) Model Number CVI4430, UDI/DI (EA) 10653160314370, UDI/DI (CS) 00653160314373;  s) Model Number CVI4450A, UDI/DI (EA) 10653160320517, UDI/DI (CS) 00653160320510;  t) Model Number CVI4505, UDI/DI (EA) 10653160319047, UDI/DI (CS) 00653160319040;  u) Model Number CVI4655, UDI/DI (EA) 10193489190373, UDI/DI (CS) 20193489190370;  v) Model Number CVI4725, UDI/DI (EA) 10193489199871, UDI/DI (CS) 20193489199878;  w) Model Number CVI4830A, UDI/DI (EA) 10653160353553, UDI/DI (CS) 00653160353556;  x) Model Number CVI4830B, UDI/DI (EA) 10653160358534, UDI/DI (CS) 00653160358537;  y) Model Number CVI4905, UDI/DI (EA) 10653160355618, UDI/DI (CS) 00653160355611;  z) Model Number CVI4920, UDI/DI (EA) 10653160355847, UDI/DI (CS) 00653160355840;  aa) Model Number DT22570A, UDI/DI (EA) 10653160346074, UDI/DI (CS) 00653160346077;  bb) Model Number DT22860, UDI/DI (EA) 10653160359142, UDI/DI (CS) 00653160359145;  cc) Model Number DYKM1790A, UDI/DI (EA) 10193489112412, UDI/DI (CS) 20193489112419;  dd) Model Number DYND2673B, UDI/DI (EA) 10193489191394, UDI/DI (CS) 20193489191391;  ee) Model Number DYNDA2238A, UDI/DI (EA) 10193489191554, UDI/DI (CS) 20193489191551;  ff) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 20193489111245;  gg) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 20193489197089;  hh) Model Number DYNDH1542, UDI/DI (EA) 10193489197396, UDI/DI (CS) 20193489197393;  ii) Model Number DYNDH1661, UDI/DI (EA) 10193489111521, UDI/DI (CS) 20193489111528;  jj) Model Number DYNDV2536A, UDI/DI (EA) 10653160357872, UDI/DI (CS) 00653160357875;  kk) Model Number DYNJ0182378B, UDI/DI (EA) 10653160338536, UDI/DI (CS) 00653160338539;  ll) Model Number MNS11590, UDI/DI (EA) 10653160321293, UDI/DI (CS) 00653160321296;  mm) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 00653160322132;  nn) Model Number MNS12065, UDI/DI (EA) 10653160331193, UDI/DI (CS) 00653160331196;  oo) Model Number P155598, UDI/DI (EA) 10888277902237, UDI/DI (CS) 40888277902238;  pp) Model Number P482986, UDI/DI (EA) 10888277903630, UDI/DI (CS) 40888277903631;  qq) Model Number SPEC0232, UDI/DI (EA) 10888277507418, UDI/DI (CS) 40888277507419;  rr) Model Number SPEC0291B, UDI/DI (EA) 10889942453054, UDI/DI (CS) 40889942453055;. 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-2199-2023&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-2199-2023&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-2199-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2199-2023 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-2199-2023&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-2199-2023&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-2199-2023/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-2199-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2199-2023",
            "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 Number ART1005, UDI/DI (EA) 10193489198232, UDI/DI (CS) 20193489198239;  b) Model Number ART1165, UDI/DI (EA) 10653160354680, UDI/DI (CS) 00653160354683;  c) Model Number ART240A, UDI/DI (EA) 10653160328025, UDI/DI (CS) 00653160328028;  d) Model Number ART245A, UDI/DI (EA) 10653160328018, UDI/DI (CS) 00653160328011;  e) Model Number ART245B, UDI/DI (EA) 10653160358442, UDI/DI (CS) 00653160358445;  f) Model Number ART255, UDI/DI (EA) 10653160311997, UDI/DI (CS) 00653160311990;  g) Model Number ART560, UDI/DI (EA) 10653160310822, UDI/DI (CS) 00653160310825;  h) Model Number ART690, UDI/DI (EA) 10653160318019, UDI/DI (CS) 00653160318012;  i) Model Number ART840, UDI/DI (EA) 10653160322924, UDI/DI (CS) 00653160322927;  j) Model Number ART960, UDI/DI (EA) 10193489190915, UDI/DI (CS) 20193489190912;  k) Model Number ART970, UDI/DI (EA) 10193489190922, UDI/DI (CS) 20193489190929;  l) Model Number BT235A, UDI/DI (EA) 10653160315919, UDI/DI (CS) 00653160315912;  m) Model Number CHT1825, UDI/DI (EA) 10653160328988, UDI/DI (CS) 00653160328981;  n) Model Number CVI3735, UDI/DI (EA) 10653160261544, UDI/DI (CS) 00653160261547;  o) Model Number CVI4025A, UDI/DI (EA) 10193489396058, UDI/DI (CS) 40193489396059;  p) Model Number CVI4180, UDI/DI (EA) 10653160284451, UDI/DI (CS) 00653160284454;  q) Model Number CVI4265, UDI/DI (EA) 10653160291268, UDI/DI (CS) 00653160291261;  r) Model Number CVI4430, UDI/DI (EA) 10653160314370, UDI/DI (CS) 00653160314373;  s) Model Number CVI4450A, UDI/DI (EA) 10653160320517, UDI/DI (CS) 00653160320510;  t) Model Number CVI4505, UDI/DI (EA) 10653160319047, UDI/DI (CS) 00653160319040;  u) Model Number CVI4655, UDI/DI (EA) 10193489190373, UDI/DI (CS) 20193489190370;  v) Model Number CVI4725, UDI/DI (EA) 10193489199871, UDI/DI (CS) 20193489199878;  w) Model Number CVI4830A, UDI/DI (EA) 10653160353553, UDI/DI (CS) 00653160353556;  x) Model Number CVI4830B, UDI/DI (EA) 10653160358534, UDI/DI (CS) 00653160358537;  y) Model Number CVI4905, UDI/DI (EA) 10653160355618, UDI/DI (CS) 00653160355611;  z) Model Number CVI4920, UDI/DI (EA) 10653160355847, UDI/DI (CS) 00653160355840;  aa) Model Number DT22570A, UDI/DI (EA) 10653160346074, UDI/DI (CS) 00653160346077;  bb) Model Number DT22860, UDI/DI (EA) 10653160359142, UDI/DI (CS) 00653160359145;  cc) Model Number DYKM1790A, UDI/DI (EA) 10193489112412, UDI/DI (CS) 20193489112419;  dd) Model Number DYND2673B, UDI/DI (EA) 10193489191394, UDI/DI (CS) 20193489191391;  ee) Model Number DYNDA2238A, UDI/DI (EA) 10193489191554, UDI/DI (CS) 20193489191551;  ff) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 20193489111245;  gg) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 20193489197089;  hh) Model Number DYNDH1542, UDI/DI (EA) 10193489197396, UDI/DI (CS) 20193489197393;  ii) Model Number DYNDH1661, UDI/DI (EA) 10193489111521, UDI/DI (CS) 20193489111528;  jj) Model Number DYNDV2536A, UDI/DI (EA) 10653160357872, UDI/DI (CS) 00653160357875;  kk) Model Number DYNJ0182378B, UDI/DI (EA) 10653160338536, UDI/DI (CS) 00653160338539;  ll) Model Number MNS11590, UDI/DI (EA) 10653160321293, UDI/DI (CS) 00653160321296;  mm) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 00653160322132;  nn) Model Number MNS12065, UDI/DI (EA) 10653160331193, UDI/DI (CS) 00653160331196;  oo) Model Number P155598, UDI/DI (EA) 10888277902237, UDI/DI (CS) 40888277902238;  pp) Model Number P482986, UDI/DI (EA) 10888277903630, UDI/DI (CS) 40888277903631;  qq) Model Number SPEC0232, UDI/DI (EA) 10888277507418, UDI/DI (CS) 40888277507419;  rr) Model Number SPEC0291B, UDI/DI (EA) 10889942453054, UDI/DI (CS) 40889942453055;",
            "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"
          }
        }
      ]
    }
  ]
}