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    "occurred": "au:occurred",
    "supported": "au:supported",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2166-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102G;  b)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102I;  c)\tCUSTOM CARDIAC CABG, Model Number DYNJ906108C;  d)\tVASCULAR STENT INOVA, Model Number DYNJ906440A;  e)\tCABG, Model Number DYNJ906878A;  f)\tVALVE, Model Number DYNJ906882A;  g)\tVASCULAR, Model Number DYNJ906883A;  h)\tDR WILLIAMS HEART, Model Number DYNJ907552A;  i)\tPUH PERCUTANEOUS ECMO, Model Number DYNJ907554C;  j)\tTAVR, Model Number DYNJ907561A;  k)\tTAVR, Model Number DYNJ907561B;  l)\tTAVR, Model Number DYNJ907561C;  m)\tOPEN HEART CDS, Model Number DYNJ907607A;  n)\tOPEN HEART CDS, Model Number DYNJ907607B;  o)\tOPEN HEART CDS, Model Number DYNJ907607C;  p)\tOPEN VASCULAR UE, Model Number DYNJ907858A;  q)\tPACEMAKER, Model Number DYNJ907907;  r)\tDEBOER HEART, Model Number DYNJ907914A;  s)\tDEBOER HEART, Model Number DYNJ907914B;  t)\tDEBOER HEART, Model Number DYNJ907914C;  u)\tGENERAL HEART, Model Number DYNJ907915;  v)\tAV FISTULA, Model Number DYNJ907975;  w)\tAV FISTULA, Model Number DYNJ907975A;  x)\tAV FISTULA, Model Number DYNJ907975B;  y)\tSAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B;  z)\tCARDIAC CABG B, Model Number DYNJ908121B;  aa)\tOPEN HEART LINE SET UP, Model Number DYNJ908179A;  bb)\tSTEWARD VASCULAR SAS, Model Number DYNJ908563;  cc)\tTAVR, Model Number DYNJ908646;  dd)\tTAVR, Model Number DYNJ908646A;  ee)\tENDOVASCULAR, Model Number DYNJ908880;  ff)\tENDOVASCULAR, Model Number DYNJ908880A;  gg)\tVASCULAR, Model Number DYNJ909091;  hh)\tENDOVASCULAR, Model Number DYNJ909253;  ii)\tTAVR, Model Number DYNJ909270;  jj)\tCABG, Model Number DYNJ9372030G;  kk)\tOPEN HEART, Model Number DYNJ9718008AS;  ll)\tADULT CORONARY PACK, Model Number DYNJV0275M;  mm)\tRADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A;  nn)\tVASCULAR PACK, Model Number DYNJVB1307;  oo)\tVASCULAR PACK, Model Number DYNJVB1307A;  pp)\tVASCULAR EXTREMITY PPS, Model Number DYNJVB91063C;  qq)\tENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067;  rr)\tPERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A;  ss)\tVEIN PACK-LF, Model Number PHS151095000;  tt)\tE P PACK-LF, Model Number PHS41732B;  uu)\tPICC VASCULAR ACCESS PACK, Model Number PICCNC0010;  vv)\tTVS4000 ENDOVENOUS PACK, Model Number TVS4000L;",
  "description": "FDA recall Z-2166-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102G;  b)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102I;  c)\tCUSTOM CARDIAC CABG, Model Number DYNJ906108C;  d)\tVASCULAR STENT INOVA, Model Number DYNJ906440A;  e)\tCABG, Model Number DYNJ906878A;  f)\tVALVE, Model Number DYNJ906882A;  g)\tVASCULAR, Model Number DYNJ906883A;  h)\tDR WILLIAMS HEART, Model Number DYNJ907552A;  i)\tPUH PERCUTANEOUS ECMO, Model Number DYNJ907554C;  j)\tTAVR, Model Number DYNJ907561A;  k)\tTAVR, Model Number DYNJ907561B;  l)\tTAVR, Model Number DYNJ907561C;  m)\tOPEN HEART CDS, Model Number DYNJ907607A;  n)\tOPEN HEART CDS, Model Number DYNJ907607B;  o)\tOPEN HEART CDS, Model Number DYNJ907607C;  p)\tOPEN VASCULAR UE, Model Number DYNJ907858A;  q)\tPACEMAKER, Model Number DYNJ907907;  r)\tDEBOER HEART, Model Number DYNJ907914A;  s)\tDEBOER HEART, Model Number DYNJ907914B;  t)\tDEBOER HEART, Model Number DYNJ907914C;  u)\tGENERAL HEART, Model Number DYNJ907915;  v)\tAV FISTULA, Model Number DYNJ907975;  w)\tAV FISTULA, Model Number DYNJ907975A;  x)\tAV FISTULA, Model Number DYNJ907975B;  y)\tSAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B;  z)\tCARDIAC CABG B, Model Number DYNJ908121B;  aa)\tOPEN HEART LINE SET UP, Model Number DYNJ908179A;  bb)\tSTEWARD VASCULAR SAS, Model Number DYNJ908563;  cc)\tTAVR, Model Number DYNJ908646;  dd)\tTAVR, Model Number DYNJ908646A;  ee)\tENDOVASCULAR, Model Number DYNJ908880;  ff)\tENDOVASCULAR, Model Number DYNJ908880A;  gg)\tVASCULAR, Model Number DYNJ909091;  hh)\tENDOVASCULAR, Model Number DYNJ909253;  ii)\tTAVR, Model Number DYNJ909270;  jj)\tCABG, Model Number DYNJ9372030G;  kk)\tOPEN HEART, Model Number DYNJ9718008AS;  ll)\tADULT CORONARY PACK, Model Number DYNJV0275M;  mm)\tRADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A;  nn)\tVASCULAR PACK, Model Number DYNJVB1307;  oo)\tVASCULAR PACK, Model Number DYNJVB1307A;  pp)\tVASCULAR EXTREMITY PPS, Model Number DYNJVB91063C;  qq)\tENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067;  rr)\tPERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A;  ss)\tVEIN PACK-LF, Model Number PHS151095000;  tt)\tE P PACK-LF, Model Number PHS41732B;  uu)\tPICC VASCULAR ACCESS PACK, Model Number PICCNC0010;  vv)\tTVS4000 ENDOVENOUS PACK, Model Number TVS4000L; (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
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    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2166-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102G;  b)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102I;  c)\tCUSTOM CARDIAC CABG, Model Number DYNJ906108C;  d)\tVASCULAR STENT INOVA, Model Number DYNJ906440A;  e)\tCABG, Model Number DYNJ906878A;  f)\tVALVE, Model Number DYNJ906882A;  g)\tVASCULAR, Model Number DYNJ906883A;  h)\tDR WILLIAMS HEART, Model Number DYNJ907552A;  i)\tPUH PERCUTANEOUS ECMO, Model Number DYNJ907554C;  j)\tTAVR, Model Number DYNJ907561A;  k)\tTAVR, Model Number DYNJ907561B;  l)\tTAVR, Model Number DYNJ907561C;  m)\tOPEN HEART CDS, Model Number DYNJ907607A;  n)\tOPEN HEART CDS, Model Number DYNJ907607B;  o)\tOPEN HEART CDS, Model Number DYNJ907607C;  p)\tOPEN VASCULAR UE, Model Number DYNJ907858A;  q)\tPACEMAKER, Model Number DYNJ907907;  r)\tDEBOER HEART, Model Number DYNJ907914A;  s)\tDEBOER HEART, Model Number DYNJ907914B;  t)\tDEBOER HEART, Model Number DYNJ907914C;  u)\tGENERAL HEART, Model Number DYNJ907915;  v)\tAV FISTULA, Model Number DYNJ907975;  w)\tAV FISTULA, Model Number DYNJ907975A;  x)\tAV FISTULA, Model Number DYNJ907975B;  y)\tSAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B;  z)\tCARDIAC CABG B, Model Number DYNJ908121B;  aa)\tOPEN HEART LINE SET UP, Model Number DYNJ908179A;  bb)\tSTEWARD VASCULAR SAS, Model Number DYNJ908563;  cc)\tTAVR, Model Number DYNJ908646;  dd)\tTAVR, Model Number DYNJ908646A;  ee)\tENDOVASCULAR, Model Number DYNJ908880;  ff)\tENDOVASCULAR, Model Number DYNJ908880A;  gg)\tVASCULAR, Model Number DYNJ909091;  hh)\tENDOVASCULAR, Model Number DYNJ909253;  ii)\tTAVR, Model Number DYNJ909270;  jj)\tCABG, Model Number DYNJ9372030G;  kk)\tOPEN HEART, Model Number DYNJ9718008AS;  ll)\tADULT CORONARY PACK, Model Number DYNJV0275M;  mm)\tRADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A;  nn)\tVASCULAR PACK, Model Number DYNJVB1307;  oo)\tVASCULAR PACK, Model Number DYNJVB1307A;  pp)\tVASCULAR EXTREMITY PPS, Model Number DYNJVB91063C;  qq)\tENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067;  rr)\tPERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A;  ss)\tVEIN PACK-LF, Model Number PHS151095000;  tt)\tE P PACK-LF, Model Number PHS41732B;  uu)\tPICC VASCULAR ACCESS PACK, Model Number PICCNC0010;  vv)\tTVS4000 ENDOVENOUS PACK, Model Number TVS4000L;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2166-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2166-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102G;  b)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102I;  c)\tCUSTOM CARDIAC CABG, Model Number DYNJ906108C;  d)\tVASCULAR STENT INOVA, Model Number DYNJ906440A;  e)\tCABG, Model Number DYNJ906878A;  f)\tVALVE, Model Number DYNJ906882A;  g)\tVASCULAR, Model Number DYNJ906883A;  h)\tDR WILLIAMS HEART, Model Number DYNJ907552A;  i)\tPUH PERCUTANEOUS ECMO, Model Number DYNJ907554C;  j)\tTAVR, Model Number DYNJ907561A;  k)\tTAVR, Model Number DYNJ907561B;  l)\tTAVR, Model Number DYNJ907561C;  m)\tOPEN HEART CDS, Model Number DYNJ907607A;  n)\tOPEN HEART CDS, Model Number DYNJ907607B;  o)\tOPEN HEART CDS, Model Number DYNJ907607C;  p)\tOPEN VASCULAR UE, Model Number DYNJ907858A;  q)\tPACEMAKER, Model Number DYNJ907907;  r)\tDEBOER HEART, Model Number DYNJ907914A;  s)\tDEBOER HEART, Model Number DYNJ907914B;  t)\tDEBOER HEART, Model Number DYNJ907914C;  u)\tGENERAL HEART, Model Number DYNJ907915;  v)\tAV FISTULA, Model Number DYNJ907975;  w)\tAV FISTULA, Model Number DYNJ907975A;  x)\tAV FISTULA, Model Number DYNJ907975B;  y)\tSAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B;  z)\tCARDIAC CABG B, Model Number DYNJ908121B;  aa)\tOPEN HEART LINE SET UP, Model Number DYNJ908179A;  bb)\tSTEWARD VASCULAR SAS, Model Number DYNJ908563;  cc)\tTAVR, Model Number DYNJ908646;  dd)\tTAVR, Model Number DYNJ908646A;  ee)\tENDOVASCULAR, Model Number DYNJ908880;  ff)\tENDOVASCULAR, Model Number DYNJ908880A;  gg)\tVASCULAR, Model Number DYNJ909091;  hh)\tENDOVASCULAR, Model Number DYNJ909253;  ii)\tTAVR, Model Number DYNJ909270;  jj)\tCABG, Model Number DYNJ9372030G;  kk)\tOPEN HEART, Model Number DYNJ9718008AS;  ll)\tADULT CORONARY PACK, Model Number DYNJV0275M;  mm)\tRADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A;  nn)\tVASCULAR PACK, Model Number DYNJVB1307;  oo)\tVASCULAR PACK, Model Number DYNJVB1307A;  pp)\tVASCULAR EXTREMITY PPS, Model Number DYNJVB91063C;  qq)\tENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067;  rr)\tPERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A;  ss)\tVEIN PACK-LF, Model Number PHS151095000;  tt)\tE P PACK-LF, Model Number PHS41732B;  uu)\tPICC VASCULAR ACCESS PACK, Model Number PICCNC0010;  vv)\tTVS4000 ENDOVENOUS PACK, Model Number TVS4000L;",
      "text": "The FDA logged enforcement record Z-2166-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102G;  b)\tSILVER CROSS OPEN HEART, Model Number DYNJ906102I;  c)\tCUSTOM CARDIAC CABG, Model Number DYNJ906108C;  d)\tVASCULAR STENT INOVA, Model Number DYNJ906440A;  e)\tCABG, Model Number DYNJ906878A;  f)\tVALVE, Model Number DYNJ906882A;  g)\tVASCULAR, Model Number DYNJ906883A;  h)\tDR WILLIAMS HEART, Model Number DYNJ907552A;  i)\tPUH PERCUTANEOUS ECMO, Model Number DYNJ907554C;  j)\tTAVR, Model Number DYNJ907561A;  k)\tTAVR, Model Number DYNJ907561B;  l)\tTAVR, Model Number DYNJ907561C;  m)\tOPEN HEART CDS, Model Number DYNJ907607A;  n)\tOPEN HEART CDS, Model Number DYNJ907607B;  o)\tOPEN HEART CDS, Model Number DYNJ907607C;  p)\tOPEN VASCULAR UE, Model Number DYNJ907858A;  q)\tPACEMAKER, Model Number DYNJ907907;  r)\tDEBOER HEART, Model Number DYNJ907914A;  s)\tDEBOER HEART, Model Number DYNJ907914B;  t)\tDEBOER HEART, Model Number DYNJ907914C;  u)\tGENERAL HEART, Model Number DYNJ907915;  v)\tAV FISTULA, Model Number DYNJ907975;  w)\tAV FISTULA, Model Number DYNJ907975A;  x)\tAV FISTULA, Model Number DYNJ907975B;  y)\tSAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B;  z)\tCARDIAC CABG B, Model Number DYNJ908121B;  aa)\tOPEN HEART LINE SET UP, Model Number DYNJ908179A;  bb)\tSTEWARD VASCULAR SAS, Model Number DYNJ908563;  cc)\tTAVR, Model Number DYNJ908646;  dd)\tTAVR, Model Number DYNJ908646A;  ee)\tENDOVASCULAR, Model Number DYNJ908880;  ff)\tENDOVASCULAR, Model Number DYNJ908880A;  gg)\tVASCULAR, Model Number DYNJ909091;  hh)\tENDOVASCULAR, Model Number DYNJ909253;  ii)\tTAVR, Model Number DYNJ909270;  jj)\tCABG, Model Number DYNJ9372030G;  kk)\tOPEN HEART, Model Number DYNJ9718008AS;  ll)\tADULT CORONARY PACK, Model Number DYNJV0275M;  mm)\tRADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A;  nn)\tVASCULAR PACK, Model Number DYNJVB1307;  oo)\tVASCULAR PACK, Model Number DYNJVB1307A;  pp)\tVASCULAR EXTREMITY PPS, Model Number DYNJVB91063C;  qq)\tENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067;  rr)\tPERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A;  ss)\tVEIN PACK-LF, Model Number PHS151095000;  tt)\tE P PACK-LF, Model Number PHS41732B;  uu)\tPICC VASCULAR ACCESS PACK, Model Number PICCNC0010;  vv)\tTVS4000 ENDOVENOUS PACK, Model Number TVS4000L; — reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-18. Affected lots/codes: all lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Numbers DYNJ906102G, UDI/DI (EA)10195327290795, UDI/DI (CS)40195327290796;  b) Model Numbers DYNJ906102I, UDI/DI (EA)10195327323349, UDI/DI (CS)40195327323340;  c) Model Numbers DYNJ906108C, UDI/DI (EA)10195327118273, UDI/DI (CS)40195327118274;  d) Model Numbers DYNJ906440A, UDI/DI (EA)10193489312874, UDI/DI (CS)40193489312875;  e) Model Numbers DYNJ906878A, UDI/DI (EA)10193489391305, UDI/DI (CS)40193489391306;  f) Model Numbers DYNJ906882A, UDI/DI (EA)10193489391237, UDI/DI (CS)40193489391238;  g) Model Numbers DYNJ906883A, UDI/DI (EA)10193489398205, UDI/DI (CS)40193489398206;  h) Model Numbers DYNJ907552A, UDI/DI (EA)10195327166052, UDI/DI (CS)40195327166053;  i) Model Numbers DYNJ907554C, UDI/DI (EA)10195327183837, UDI/DI (CS)40195327183838;  j) Model Numbers DYNJ907561A, UDI/DI (EA)10195327028848, UDI/DI (CS)40195327028849;  k) Model Numbers DYNJ907561B, UDI/DI (EA)10195327290832, UDI/DI (CS)40195327290833;  l) Model Numbers DYNJ907561C, UDI/DI (EA)10195327323271, UDI/DI (CS)40195327323272;  m) Model Numbers DYNJ907607A, UDI/DI (EA)10193489873405, UDI/DI (CS)40193489873406;  n) Model Numbers DYNJ907607B, UDI/DI (EA)10195327174194, UDI/DI (CS)40195327174195;  o) Model Numbers DYNJ907607C, UDI/DI (EA)10195327335519, UDI/DI (CS)40195327335510;  p) Model Numbers DYNJ907858A, UDI/DI (EA)10195327131357, UDI/DI (CS)40195327131358;  q) Model Numbers DYNJ907907, UDI/DI (EA)10193489939736, UDI/DI (CS)40193489939737;  r) Model Numbers DYNJ907914A, UDI/DI (EA)10195327149529, UDI/DI (CS)40195327149520;  s) Model Numbers DYNJ907914B, UDI/DI (EA)10195327180607, UDI/DI (CS)40195327180608;  t) Model Numbers DYNJ907914C, UDI/DI (EA)10195327329433, UDI/DI (CS)40195327329434;  u) Model Numbers DYNJ907915, UDI/DI (EA)10193489943689, UDI/DI (CS)40193489943680;  v) Model Numbers DYNJ907975, UDI/DI (EA)10193489965605, UDI/DI (CS)40193489965606;  w) Model Numbers DYNJ907975A, UDI/DI (EA)10195327155070, UDI/DI (CS)40195327155071;  x) Model Numbers DYNJ907975B, UDI/DI (EA)10195327376291, UDI/DI (CS)40195327376292;  y) Model Numbers DYNJ908074B, UDI/DI (EA)10195327172688, UDI/DI (CS)40195327172689;  z) Model Numbers DYNJ908121B, UDI/DI (EA)10195327095710, UDI/DI (CS)40195327095711;  aa) Model Numbers DYNJ908179A, UDI/DI (EA)10195327222574, UDI/DI (CS)40195327222575;  bb) Model Numbers DYNJ908563, UDI/DI (EA)10195327086428, UDI/DI (CS)40195327086429;  cc) Model Numbers DYNJ908646, UDI/DI (EA)10195327123956, UDI/DI (CS)40195327123957;  dd) Model Numbers DYNJ908646A, UDI/DI (EA)10195327314965, UDI/DI (CS)40195327314966;  ee) Model Numbers DYNJ908880, UDI/DI (EA)10195327203436, UDI/DI (CS)40195327203437;  ff) Model Numbers DYNJ908880A, UDI/DI (EA)10195327259198, UDI/DI (CS)40195327259199;  gg) Model Numbers DYNJ909091, UDI/DI (EA)10195327268602, UDI/DI (CS)40195327268603;  hh) Model Numbers DYNJ909253, UDI/DI (EA)10195327317027, UDI/DI (CS)40195327317028;  ii) Model Numbers DYNJ909270, UDI/DI (EA)10195327317171, UDI/DI (CS)40195327317172;  jj) Model Numbers DYNJ9372030G, UDI/DI (EA)10195327025434, UDI/DI (CS)40195327025435;  kk) Model Numbers DYNJ9718008AS, UDI/DI (EA)10193489263121, UDI/DI (CS)40193489263122;  ll) Model Numbers DYNJV0275M, UDI/DI (EA)10195327018627, UDI/DI (CS)40195327018628;  mm) Model Numbers DYNJVB1302A, UDI/DI (EA)10193489928341, UDI/DI (CS)40193489928342;  nn) Model Numbers DYNJVB1307, UDI/DI (EA)10193489872910, UDI/DI (CS)40193489872911;  oo) Model Numbers DYNJVB1307A, UDI/DI (EA)10195327227333, UDI/DI (CS)40195327227334;  pp) Model Numbers DYNJVB91063C, UDI/DI (EA)10195327257125, UDI/DI (CS)40195327257126;  qq) Model Numbers DYNJVB91067, UDI/DI (EA)10193489801538, UDI/DI (CS)40193489801539;  rr) Model Numbers PAIN1423A, UDI/DI (EA)10193489201826, UDI/DI (CS)40193489201827;  ss) Model Numbers PHS151095000, UDI/DI (EA)10889942035601, UDI/DI (CS)40889942035602;  tt) Model Numbers PHS41732B, UDI/DI (EA)10193489784817, UDI/DI (CS)40193489784818;  uu) Model Numbers PICCNC0010, UDI/DI (EA)10195327231170, UDI/DI (CS)40195327231171;  vv) Model Numbers TVS4000L, UDI/DI (EA)10195327223540, UDI/DI (CS)40195327223541;. 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-2166-2023&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-2166-2023&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-2166-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2166-2023 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-2166-2023&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-2166-2023&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-2166-2023/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-2166-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2166-2023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-18",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "all lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Numbers DYNJ906102G, UDI/DI (EA)10195327290795, UDI/DI (CS)40195327290796;  b) Model Numbers DYNJ906102I, UDI/DI (EA)10195327323349, UDI/DI (CS)40195327323340;  c) Model Numbers DYNJ906108C, UDI/DI (EA)10195327118273, UDI/DI (CS)40195327118274;  d) Model Numbers DYNJ906440A, UDI/DI (EA)10193489312874, UDI/DI (CS)40193489312875;  e) Model Numbers DYNJ906878A, UDI/DI (EA)10193489391305, UDI/DI (CS)40193489391306;  f) Model Numbers DYNJ906882A, UDI/DI (EA)10193489391237, UDI/DI (CS)40193489391238;  g) Model Numbers DYNJ906883A, UDI/DI (EA)10193489398205, UDI/DI (CS)40193489398206;  h) Model Numbers DYNJ907552A, UDI/DI (EA)10195327166052, UDI/DI (CS)40195327166053;  i) Model Numbers DYNJ907554C, UDI/DI (EA)10195327183837, UDI/DI (CS)40195327183838;  j) Model Numbers DYNJ907561A, UDI/DI (EA)10195327028848, UDI/DI (CS)40195327028849;  k) Model Numbers DYNJ907561B, UDI/DI (EA)10195327290832, UDI/DI (CS)40195327290833;  l) Model Numbers DYNJ907561C, UDI/DI (EA)10195327323271, UDI/DI (CS)40195327323272;  m) Model Numbers DYNJ907607A, UDI/DI (EA)10193489873405, UDI/DI (CS)40193489873406;  n) Model Numbers DYNJ907607B, UDI/DI (EA)10195327174194, UDI/DI (CS)40195327174195;  o) Model Numbers DYNJ907607C, UDI/DI (EA)10195327335519, UDI/DI (CS)40195327335510;  p) Model Numbers DYNJ907858A, UDI/DI (EA)10195327131357, UDI/DI (CS)40195327131358;  q) Model Numbers DYNJ907907, UDI/DI (EA)10193489939736, UDI/DI (CS)40193489939737;  r) Model Numbers DYNJ907914A, UDI/DI (EA)10195327149529, UDI/DI (CS)40195327149520;  s) Model Numbers DYNJ907914B, UDI/DI (EA)10195327180607, UDI/DI (CS)40195327180608;  t) Model Numbers DYNJ907914C, UDI/DI (EA)10195327329433, UDI/DI (CS)40195327329434;  u) Model Numbers DYNJ907915, UDI/DI (EA)10193489943689, UDI/DI (CS)40193489943680;  v) Model Numbers DYNJ907975, UDI/DI (EA)10193489965605, UDI/DI (CS)40193489965606;  w) Model Numbers DYNJ907975A, UDI/DI (EA)10195327155070, UDI/DI (CS)40195327155071;  x) Model Numbers DYNJ907975B, UDI/DI (EA)10195327376291, UDI/DI (CS)40195327376292;  y) Model Numbers DYNJ908074B, UDI/DI (EA)10195327172688, UDI/DI (CS)40195327172689;  z) Model Numbers DYNJ908121B, UDI/DI (EA)10195327095710, UDI/DI (CS)40195327095711;  aa) Model Numbers DYNJ908179A, UDI/DI (EA)10195327222574, UDI/DI (CS)40195327222575;  bb) Model Numbers DYNJ908563, UDI/DI (EA)10195327086428, UDI/DI (CS)40195327086429;  cc) Model Numbers DYNJ908646, UDI/DI (EA)10195327123956, UDI/DI (CS)40195327123957;  dd) Model Numbers DYNJ908646A, UDI/DI (EA)10195327314965, UDI/DI (CS)40195327314966;  ee) Model Numbers DYNJ908880, UDI/DI (EA)10195327203436, UDI/DI (CS)40195327203437;  ff) Model Numbers DYNJ908880A, UDI/DI (EA)10195327259198, UDI/DI (CS)40195327259199;  gg) Model Numbers DYNJ909091, UDI/DI (EA)10195327268602, UDI/DI (CS)40195327268603;  hh) Model Numbers DYNJ909253, UDI/DI (EA)10195327317027, UDI/DI (CS)40195327317028;  ii) Model Numbers DYNJ909270, UDI/DI (EA)10195327317171, UDI/DI (CS)40195327317172;  jj) Model Numbers DYNJ9372030G, UDI/DI (EA)10195327025434, UDI/DI (CS)40195327025435;  kk) Model Numbers DYNJ9718008AS, UDI/DI (EA)10193489263121, UDI/DI (CS)40193489263122;  ll) Model Numbers DYNJV0275M, UDI/DI (EA)10195327018627, UDI/DI (CS)40195327018628;  mm) Model Numbers DYNJVB1302A, UDI/DI (EA)10193489928341, UDI/DI (CS)40193489928342;  nn) Model Numbers DYNJVB1307, UDI/DI (EA)10193489872910, UDI/DI (CS)40193489872911;  oo) Model Numbers DYNJVB1307A, UDI/DI (EA)10195327227333, UDI/DI (CS)40195327227334;  pp) Model Numbers DYNJVB91063C, UDI/DI (EA)10195327257125, UDI/DI (CS)40195327257126;  qq) Model Numbers DYNJVB91067, UDI/DI (EA)10193489801538, UDI/DI (CS)40193489801539;  rr) Model Numbers PAIN1423A, UDI/DI (EA)10193489201826, UDI/DI (CS)40193489201827;  ss) Model Numbers PHS151095000, UDI/DI (EA)10889942035601, UDI/DI (CS)40889942035602;  tt) Model Numbers PHS41732B, UDI/DI (EA)10193489784817, UDI/DI (CS)40193489784818;  uu) Model Numbers PICCNC0010, UDI/DI (EA)10195327231170, UDI/DI (CS)40195327231171;  vv) Model Numbers TVS4000L, UDI/DI (EA)10195327223540, UDI/DI (CS)40195327223541;",
            "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"
          }
        }
      ]
    }
  ]
}