{
  "@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-2163-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a.\tNORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q;  b.\tPERCUTANEOUS VASCULAR CDS, Model Number CDS840487I;  c.\tBAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I;  d.\tENDOVASCULAR CDS, Model Number CDS983394I;  e.\tENDOVASCULAR CDS, Model Number CDS983394J;  f.\tENDOVASCULAR CDS, Model Number CDS983394K;  g.\tOPEN HEART CDS, Model Number CDS983513F;  h.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849D;  i.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849F;  j.\tVNUS, Model Number CDS984292I;  k.\tOPEN HEART CDS, Model Number CDS984355G;  l.\tBEDSIDE PICC CDS, Model Number CDS984642;  m.\tVASCULAR, Model Number CDS984764G;  n.\tOPEN HEART A, Model Number CDS985105O;  o.\tVASCULAR, Model Number CDS985355D;  p.\tVASCULAR, Model Number CDS985355F;  q.\tECMO KIT, Model Number CVI4955;  r.\tKIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21;  s.\tVASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526;  t.\tARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038;  u.\tDIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B;  v.\tOPEN HEART CABG PACK-LF, Model Number DYNJ0149567C;  w.\tVASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ;  x.\tOPEN HEART PACK-LF, Model Number DYNJ0371669N;  y.\tCABG PACK, Model Number DYNJ0408782AA;  z.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185K;  aa.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185M;  bb.\tOPEN HEART A & B PACK, Model Number DYNJ0450131AI;  cc.\tVASCULAR PACK-LF, Model Number DYNJ0493141J;  dd.\tRIGHT HEART PACK-LF, Model Number DYNJ0565558U;  ee.\tENDO VASCULAR PACK-LF, Model Number DYNJ0676055N;  ff.\tLOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G;  gg.\tENDOVASCULAR PACK, Model Number DYNJ0678934I;  hh.\tRR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J;  ii.\tELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D;  jj.\tVASCULAR PACK-LF, Model Number DYNJ0871182AC;  kk.\tELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D;  ll.\tEP PACK, Model Number DYNJ16618J;  mm.\tEP PACK, Model Number DYNJ16618K;  nn.\tST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C;  oo.\tVEIN PACK, Model Number DYNJ21949J;  pp.\tVASCULAR PACK, Model Number DYNJ22350L;  qq.\tEP PACK, Model Number DYNJ23456K;  rr.\tANGIO-VASCULAR, Model Number DYNJ24272C;  ss.\tEP ANGIO PACK, Model Number DYNJ25749S;  tt.\tC.V. MINOR PACK, Model Number DYNJ28849B;  uu.\tEP TRAY, Model Number DYNJ31928D;  vv.\tPACER PACK, Model Number DYNJ34844C;  ww.\tADULT CARDIO TRAY, Model Number DYNJ35495G;  xx.\tPEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G;  yy.\tCARDIO B PACK, Model Number DYNJ36052O;  zz.\tVASCULAR ENDO LASER PK, Model Number DYNJ37445I;  aaa.\tVEIN PROCEDURE PACK, Model Number DYNJ38264D;  bbb.\tHMT VEIN PACK, Model Number DYNJ38756B;  ccc.\tLASER AND VEIN PACK, Model Number DYNJ38995C;  ddd.\tVEIN CLOSURE PACK, Model Number DYNJ39408F;  eee.\tCAROTID PACK, Model Number DYNJ39488G;  fff.\tVEIN PACK, Model Number DYNJ39889;  ggg.\tCVL CUSTOM PACK, Model Number DYNJ40067G;  hhh.\tAV GRAFT-LF, Model Number DYNJ40077F;  iii.\tVASCULAR-LF, Model Number DYNJ40108I;  jjj.\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215C;  kkk.\tRIGHT HEART TRAY, Model Number DYNJ40379D;  lll.\tLINE PACK, Model Number DYNJ41100C;  mmm.\tCARDIAC CATH PACK, Model Number DYNJ41195D;  nnn.\tVEIN PK, Model Number DYNJ42976;  ooo.\tVEIN CLOSURE PACK, Model Number DYNJ43085A;  ppp.\tPROCEDURE PACK, Model Number DYNJ43922;  qqq.\tPK, RADIOLOGY-PORTSMOUTH, Model Number DYNJ44087B;  rrr.\tPACEMAKER PACK, Model Number DYNJ44345F;  sss.\tPACEMAKER PACK, Model Number DYNJ44345G;  ttt.\tVENOUS ACCESS PACK, Model Number DYNJ44421D;  uuu.\tVEIN CLOSURE TRAY, Model Number DYNJ44737B;  vvv.\tENDO LASER ABLATION PK-LF, Model Number DYNJ44808G;  www.\tPK, OPEN HEART, Model Number DYNJ45074C;  xxx.\tVASCULAR PACK, Model Number DYNJ46246A;  yyy.\tCVP PACK, Model Number DYNJ46359D;  zzz.\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ47138B;  aaaa.\tEP DRAPE PACK-LF, Model Number DYNJ47645C;  bbbb.\tRF OPEN HEAR",
  "description": "FDA recall Z-2163-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a.\tNORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q;  b.\tPERCUTANEOUS VASCULAR CDS, Model Number CDS840487I;  c.\tBAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I;  d.\tENDOVASCULAR CDS, Model Number CDS983394I;  e.\tENDOVASCULAR CDS, Model Number CDS983394J;  f.\tENDOVASCULAR CDS, Model Number CDS983394K;  g.\tOPEN HEART CDS, Model Number CDS983513F;  h.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849D;  i.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849F;  j.\tVNUS, Model Number CDS984292I;  k.\tOPEN HEART CDS, Model Number CDS984355G;  l.\tBEDSIDE PICC CDS, Model Number CDS984642;  m.\tVASCULAR, Model Number CDS984764G;  n.\tOPEN HEART A, Model Number CDS985105O;  o.\tVASCULAR, Model Number CDS985355D;  p.\tVASCULAR, Model Number CDS985355F;  q.\tECMO KIT, Model Number CVI4955;  r.\tKIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21;  s.\tVASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526;  t.\tARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038;  u.\tDIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B;  v.\tOPEN HEART CABG PACK-LF, Model Number DYNJ0149567C;  w.\tVASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ;  x.\tOPEN HEART PACK-LF, Model Number DYNJ0371669N;  y.\tCABG PACK, Model Number DYNJ0408782AA;  z.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185K;  aa.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185M;  bb.\tOPEN HEART A & B PACK, Model Number DYNJ0450131AI;  cc.\tVASCULAR PACK-LF, Model Number DYNJ0493141J;  dd.\tRIGHT HEART PACK-LF, Model Number DYNJ0565558U;  ee.\tENDO VASCULAR PACK-LF, Model Number DYNJ0676055N;  ff.\tLOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G;  gg.\tENDOVASCULAR PACK, Model Number DYNJ0678934I;  hh.\tRR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J;  ii.\tELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D;  jj.\tVASCULAR PACK-LF, Model Number DYNJ0871182AC;  kk.\tELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D;  ll.\tEP PACK, Model Number DYNJ16618J;  mm.\tEP PACK, Model Number DYNJ16618K;  nn.\tST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C;  oo.\tVEIN PACK, Model Number DYNJ21949J;  pp.\tVASCULAR PACK, Model Number DYNJ22350L;  qq.\tEP PACK, Model Number DYNJ23456K;  rr.\tANGIO-VASCULAR, Model Number DYNJ24272C;  ss.\tEP ANGIO PACK, Model Number DYNJ25749S;  tt.\tC.V. MINOR PACK, Model Number DYNJ28849B;  uu.\tEP TRAY, Model Number DYNJ31928D;  vv.\tPACER PACK, Model Number DYNJ34844C;  ww.\tADULT CARDIO TRAY, Model Number DYNJ35495G;  xx.\tPEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G;  yy.\tCARDIO B PACK, Model Number DYNJ36052O;  zz.\tVASCULAR ENDO LASER PK, Model Number DYNJ37445I;  aaa.\tVEIN PROCEDURE PACK, Model Number DYNJ38264D;  bbb.\tHMT VEIN PACK, Model Number DYNJ38756B;  ccc.\tLASER AND VEIN PACK, Model Number DYNJ38995C;  ddd.\tVEIN CLOSURE PACK, Model Number DYNJ39408F;  eee.\tCAROTID PACK, Model Number DYNJ39488G;  fff.\tVEIN PACK, Model Number DYNJ39889;  ggg.\tCVL CUSTOM PACK, Model Number DYNJ40067G;  hhh.\tAV GRAFT-LF, Model Number DYNJ40077F;  iii.\tVASCULAR-LF, Model Number DYNJ40108I;  jjj.\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215C;  kkk.\tRIGHT HEART TRAY, Model Number DYNJ40379D;  lll.\tLINE PACK, Model Number DYNJ41100C;  mmm.\tCARDIAC CATH PACK, Model Number DYNJ41195D;  nnn.\tVEIN PK, Model Number DYNJ42976;  ooo.\tVEIN CLOSURE PACK, Model Number DYNJ43085A;  ppp.\tPROCEDURE PACK, Model Number DYNJ43922;  qqq.\tPK, RADIOLOGY-PORTSMOUTH, Model Number DYNJ44087B;  rrr.\tPACEMAKER PACK, Model Number DYNJ44345F;  sss.\tPACEMAKER PACK, Model Number DYNJ44345G;  ttt.\tVENOUS ACCESS PACK, Model Number DYNJ44421D;  uuu.\tVEIN CLOSURE TRAY, Model Number DYNJ44737B;  vvv.\tENDO LASER ABLATION PK-LF, Model Number DYNJ44808G;  www.\tPK, OPEN HEART, Model Number DYNJ45074C;  xxx.\tVASCULAR PACK, Model Number DYNJ46246A;  yyy.\tCVP PACK, Model Number DYNJ46359D;  zzz.\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ47138B;  aaaa.\tEP DRAPE PACK-LF, Model Number DYNJ47645C;  bbbb.\tRF OPEN HEAR (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-2163-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a.\tNORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q;  b.\tPERCUTANEOUS VASCULAR CDS, Model Number CDS840487I;  c.\tBAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I;  d.\tENDOVASCULAR CDS, Model Number CDS983394I;  e.\tENDOVASCULAR CDS, Model Number CDS983394J;  f.\tENDOVASCULAR CDS, Model Number CDS983394K;  g.\tOPEN HEART CDS, Model Number CDS983513F;  h.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849D;  i.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849F;  j.\tVNUS, Model Number CDS984292I;  k.\tOPEN HEART CDS, Model Number CDS984355G;  l.\tBEDSIDE PICC CDS, Model Number CDS984642;  m.\tVASCULAR, Model Number CDS984764G;  n.\tOPEN HEART A, Model Number CDS985105O;  o.\tVASCULAR, Model Number CDS985355D;  p.\tVASCULAR, Model Number CDS985355F;  q.\tECMO KIT, Model Number CVI4955;  r.\tKIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21;  s.\tVASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526;  t.\tARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038;  u.\tDIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B;  v.\tOPEN HEART CABG PACK-LF, Model Number DYNJ0149567C;  w.\tVASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ;  x.\tOPEN HEART PACK-LF, Model Number DYNJ0371669N;  y.\tCABG PACK, Model Number DYNJ0408782AA;  z.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185K;  aa.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185M;  bb.\tOPEN HEART A & B PACK, Model Number DYNJ0450131AI;  cc.\tVASCULAR PACK-LF, Model Number DYNJ0493141J;  dd.\tRIGHT HEART PACK-LF, Model Number DYNJ0565558U;  ee.\tENDO VASCULAR PACK-LF, Model Number DYNJ0676055N;  ff.\tLOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G;  gg.\tENDOVASCULAR PACK, Model Number DYNJ0678934I;  hh.\tRR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J;  ii.\tELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D;  jj.\tVASCULAR PACK-LF, Model Number DYNJ0871182AC;  kk.\tELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D;  ll.\tEP PACK, Model Number DYNJ16618J;  mm.\tEP PACK, Model Number DYNJ16618K;  nn.\tST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C;  oo.\tVEIN PACK, Model Number DYNJ21949J;  pp.\tVASCULAR PACK, Model Number DYNJ22350L;  qq.\tEP PACK, Model Number DYNJ23456K;  rr.\tANGIO-VASCULAR, Model Number DYNJ24272C;  ss.\tEP ANGIO PACK, Model Number DYNJ25749S;  tt.\tC.V. MINOR PACK, Model Number DYNJ28849B;  uu.\tEP TRAY, Model Number DYNJ31928D;  vv.\tPACER PACK, Model Number DYNJ34844C;  ww.\tADULT CARDIO TRAY, Model Number DYNJ35495G;  xx.\tPEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G;  yy.\tCARDIO B PACK, Model Number DYNJ36052O;  zz.\tVASCULAR ENDO LASER PK, Model Number DYNJ37445I;  aaa.\tVEIN PROCEDURE PACK, Model Number DYNJ38264D;  bbb.\tHMT VEIN PACK, Model Number DYNJ38756B;  ccc.\tLASER AND VEIN PACK, Model Number DYNJ38995C;  ddd.\tVEIN CLOSURE PACK, Model Number DYNJ39408F;  eee.\tCAROTID PACK, Model Number DYNJ39488G;  fff.\tVEIN PACK, Model Number DYNJ39889;  ggg.\tCVL CUSTOM PACK, Model Number DYNJ40067G;  hhh.\tAV GRAFT-LF, Model Number DYNJ40077F;  iii.\tVASCULAR-LF, Model Number DYNJ40108I;  jjj.\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215C;  kkk.\tRIGHT HEART TRAY, Model Number DYNJ40379D;  lll.\tLINE PACK, Model Number DYNJ41100C;  mmm.\tCARDIAC CATH PACK, Model Number DYNJ41195D;  nnn.\tVEIN PK, Model Number DYNJ42976;  ooo.\tVEIN CLOSURE PACK, Model Number DYNJ43085A;  ppp.\tPROCEDURE PACK, Model Number DYNJ43922;  qqq.\tPK, RADIOLOGY-PORTSMOUTH, Model Number DYNJ44087B;  rrr.\tPACEMAKER PACK, Model Number DYNJ44345F;  sss.\tPACEMAKER PACK, Model Number DYNJ44345G;  ttt.\tVENOUS ACCESS PACK, Model Number DYNJ44421D;  uuu.\tVEIN CLOSURE TRAY, Model Number DYNJ44737B;  vvv.\tENDO LASER ABLATION PK-LF, Model Number DYNJ44808G;  www.\tPK, OPEN HEART, Model Number DYNJ45074C;  xxx.\tVASCULAR PACK, Model Number DYNJ46246A;  yyy.\tCVP PACK, Model Number DYNJ46359D;  zzz.\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ47138B;  aaaa.\tEP DRAPE PACK-LF, Model Number DYNJ47645C;  bbbb.\tRF OPEN HEAR",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2163-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2163-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a.\tNORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q;  b.\tPERCUTANEOUS VASCULAR CDS, Model Number CDS840487I;  c.\tBAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I;  d.\tENDOVASCULAR CDS, Model Number CDS983394I;  e.\tENDOVASCULAR CDS, Model Number CDS983394J;  f.\tENDOVASCULAR CDS, Model Number CDS983394K;  g.\tOPEN HEART CDS, Model Number CDS983513F;  h.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849D;  i.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849F;  j.\tVNUS, Model Number CDS984292I;  k.\tOPEN HEART CDS, Model Number CDS984355G;  l.\tBEDSIDE PICC CDS, Model Number CDS984642;  m.\tVASCULAR, Model Number CDS984764G;  n.\tOPEN HEART A, Model Number CDS985105O;  o.\tVASCULAR, Model Number CDS985355D;  p.\tVASCULAR, Model Number CDS985355F;  q.\tECMO KIT, Model Number CVI4955;  r.\tKIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21;  s.\tVASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526;  t.\tARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038;  u.\tDIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B;  v.\tOPEN HEART CABG PACK-LF, Model Number DYNJ0149567C;  w.\tVASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ;  x.\tOPEN HEART PACK-LF, Model Number DYNJ0371669N;  y.\tCABG PACK, Model Number DYNJ0408782AA;  z.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185K;  aa.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185M;  bb.\tOPEN HEART A & B PACK, Model Number DYNJ0450131AI;  cc.\tVASCULAR PACK-LF, Model Number DYNJ0493141J;  dd.\tRIGHT HEART PACK-LF, Model Number DYNJ0565558U;  ee.\tENDO VASCULAR PACK-LF, Model Number DYNJ0676055N;  ff.\tLOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G;  gg.\tENDOVASCULAR PACK, Model Number DYNJ0678934I;  hh.\tRR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J;  ii.\tELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D;  jj.\tVASCULAR PACK-LF, Model Number DYNJ0871182AC;  kk.\tELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D;  ll.\tEP PACK, Model Number DYNJ16618J;  mm.\tEP PACK, Model Number DYNJ16618K;  nn.\tST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C;  oo.\tVEIN PACK, Model Number DYNJ21949J;  pp.\tVASCULAR PACK, Model Number DYNJ22350L;  qq.\tEP PACK, Model Number DYNJ23456K;  rr.\tANGIO-VASCULAR, Model Number DYNJ24272C;  ss.\tEP ANGIO PACK, Model Number DYNJ25749S;  tt.\tC.V. MINOR PACK, Model Number DYNJ28849B;  uu.\tEP TRAY, Model Number DYNJ31928D;  vv.\tPACER PACK, Model Number DYNJ34844C;  ww.\tADULT CARDIO TRAY, Model Number DYNJ35495G;  xx.\tPEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G;  yy.\tCARDIO B PACK, Model Number DYNJ36052O;  zz.\tVASCULAR ENDO LASER PK, Model Number DYNJ37445I;  aaa.\tVEIN PROCEDURE PACK, Model Number DYNJ38264D;  bbb.\tHMT VEIN PACK, Model Number DYNJ38756B;  ccc.\tLASER AND VEIN PACK, Model Number DYNJ38995C;  ddd.\tVEIN CLOSURE PACK, Model Number DYNJ39408F;  eee.\tCAROTID PACK, Model Number DYNJ39488G;  fff.\tVEIN PACK, Model Number DYNJ39889;  ggg.\tCVL CUSTOM PACK, Model Number DYNJ40067G;  hhh.\tAV GRAFT-LF, Model Number DYNJ40077F;  iii.\tVASCULAR-LF, Model Number DYNJ40108I;  jjj.\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215C;  kkk.\tRIGHT HEART TRAY, Model Number DYNJ40379D;  lll.\tLINE PACK, Model Number DYNJ41100C;  mmm.\tCARDIAC CATH PACK, Model Number DYNJ41195D;  nnn.\tVEIN PK, Model Number DYNJ42976;  ooo.\tVEIN CLOSURE PACK, Model Number DYNJ43085A;  ppp.\tPROCEDURE PACK, Model Number DYNJ43922;  qqq.\tPK, RADIOLOGY-PORTSMOUTH, Model Number DYNJ44087B;  rrr.\tPACEMAKER PACK, Model Number DYNJ44345F;  sss.\tPACEMAKER PACK, Model Number DYNJ44345G;  ttt.\tVENOUS ACCESS PACK, Model Number DYNJ44421D;  uuu.\tVEIN CLOSURE TRAY, Model Number DYNJ44737B;  vvv.\tENDO LASER ABLATION PK-LF, Model Number DYNJ44808G;  www.\tPK, OPEN HEART, Model Number DYNJ45074C;  xxx.\tVASCULAR PACK, Model Number DYNJ46246A;  yyy.\tCVP PACK, Model Number DYNJ46359D;  zzz.\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ47138B;  aaaa.\tEP DRAPE PACK-LF, Model Number DYNJ47645C;  bbbb.\tRF OPEN HEAR",
      "text": "The FDA logged enforcement record Z-2163-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a.\tNORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q;  b.\tPERCUTANEOUS VASCULAR CDS, Model Number CDS840487I;  c.\tBAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I;  d.\tENDOVASCULAR CDS, Model Number CDS983394I;  e.\tENDOVASCULAR CDS, Model Number CDS983394J;  f.\tENDOVASCULAR CDS, Model Number CDS983394K;  g.\tOPEN HEART CDS, Model Number CDS983513F;  h.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849D;  i.\tOPEN HEART ANESTHESIA PACK, Model Number CDS983849F;  j.\tVNUS, Model Number CDS984292I;  k.\tOPEN HEART CDS, Model Number CDS984355G;  l.\tBEDSIDE PICC CDS, Model Number CDS984642;  m.\tVASCULAR, Model Number CDS984764G;  n.\tOPEN HEART A, Model Number CDS985105O;  o.\tVASCULAR, Model Number CDS985355D;  p.\tVASCULAR, Model Number CDS985355F;  q.\tECMO KIT, Model Number CVI4955;  r.\tKIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21;  s.\tVASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526;  t.\tARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038;  u.\tDIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B;  v.\tOPEN HEART CABG PACK-LF, Model Number DYNJ0149567C;  w.\tVASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ;  x.\tOPEN HEART PACK-LF, Model Number DYNJ0371669N;  y.\tCABG PACK, Model Number DYNJ0408782AA;  z.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185K;  aa.\tCARDIAC EP PACK-LF, Model Number DYNJ0429185M;  bb.\tOPEN HEART A & B PACK, Model Number DYNJ0450131AI;  cc.\tVASCULAR PACK-LF, Model Number DYNJ0493141J;  dd.\tRIGHT HEART PACK-LF, Model Number DYNJ0565558U;  ee.\tENDO VASCULAR PACK-LF, Model Number DYNJ0676055N;  ff.\tLOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G;  gg.\tENDOVASCULAR PACK, Model Number DYNJ0678934I;  hh.\tRR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J;  ii.\tELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D;  jj.\tVASCULAR PACK-LF, Model Number DYNJ0871182AC;  kk.\tELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D;  ll.\tEP PACK, Model Number DYNJ16618J;  mm.\tEP PACK, Model Number DYNJ16618K;  nn.\tST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C;  oo.\tVEIN PACK, Model Number DYNJ21949J;  pp.\tVASCULAR PACK, Model Number DYNJ22350L;  qq.\tEP PACK, Model Number DYNJ23456K;  rr.\tANGIO-VASCULAR, Model Number DYNJ24272C;  ss.\tEP ANGIO PACK, Model Number DYNJ25749S;  tt.\tC.V. MINOR PACK, Model Number DYNJ28849B;  uu.\tEP TRAY, Model Number DYNJ31928D;  vv.\tPACER PACK, Model Number DYNJ34844C;  ww.\tADULT CARDIO TRAY, Model Number DYNJ35495G;  xx.\tPEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G;  yy.\tCARDIO B PACK, Model Number DYNJ36052O;  zz.\tVASCULAR ENDO LASER PK, Model Number DYNJ37445I;  aaa.\tVEIN PROCEDURE PACK, Model Number DYNJ38264D;  bbb.\tHMT VEIN PACK, Model Number DYNJ38756B;  ccc.\tLASER AND VEIN PACK, Model Number DYNJ38995C;  ddd.\tVEIN CLOSURE PACK, Model Number DYNJ39408F;  eee.\tCAROTID PACK, Model Number DYNJ39488G;  fff.\tVEIN PACK, Model Number DYNJ39889;  ggg.\tCVL CUSTOM PACK, Model Number DYNJ40067G;  hhh.\tAV GRAFT-LF, Model Number DYNJ40077F;  iii.\tVASCULAR-LF, Model Number DYNJ40108I;  jjj.\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215C;  kkk.\tRIGHT HEART TRAY, Model Number DYNJ40379D;  lll.\tLINE PACK, Model Number DYNJ41100C;  mmm.\tCARDIAC CATH PACK, Model Number DYNJ41195D;  nnn.\tVEIN PK, Model Number DYNJ42976;  ooo.\tVEIN CLOSURE PACK, Model Number DYNJ43085A;  ppp.\tPROCEDURE PACK, Model Number DYNJ43922;  qqq.\tPK, RADIOLOGY-PORTSMOUTH, Model Number DYNJ44087B;  rrr.\tPACEMAKER PACK, Model Number DYNJ44345F;  sss.\tPACEMAKER PACK, Model Number DYNJ44345G;  ttt.\tVENOUS ACCESS PACK, Model Number DYNJ44421D;  uuu.\tVEIN CLOSURE TRAY, Model Number DYNJ44737B;  vvv.\tENDO LASER ABLATION PK-LF, Model Number DYNJ44808G;  www.\tPK, OPEN HEART, Model Number DYNJ45074C;  xxx.\tVASCULAR PACK, Model Number DYNJ46246A;  yyy.\tCVP PACK, Model Number DYNJ46359D;  zzz.\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ47138B;  aaaa.\tEP DRAPE PACK-LF, Model Number DYNJ47645C;  bbbb.\tRF OPEN HEAR — 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 00-401185Q, UDI/DI (EA) 10193489489088, UDI/DI (CS)40193489489089;  b) Model Number CDS840487I, UDI/DI (EA) 10193489445343, UDI/DI (CS)40193489445344;  c) Model Number CDS983147I, UDI/DI (EA) 10195327075514, UDI/DI (CS)40195327075515;  d) Model Number CDS983394I, UDI/DI (EA) 10193489819953, UDI/DI (CS)40193489819954;  e) Model Number CDS983394J, UDI/DI (EA) 10195327069872, UDI/DI (CS)40195327069873;  f) Model Number CDS983394K, UDI/DI (EA) 10195327292584, UDI/DI (CS)40195327292585;  g) Model Number CDS983513F, UDI/DI (EA) 10193489843729, UDI/DI (CS)40193489843720;  h) Model Number CDS983849D, UDI/DI (EA) 10193489278231, UDI/DI (CS)40193489278232;  i) Model Number CDS983849F, UDI/DI (EA) 10195327228316, UDI/DI (CS)40195327228317;  j) Model Number CDS984292I, UDI/DI (EA) 10193489862485, UDI/DI (CS)40193489862486;  k) Model Number CDS984355G, UDI/DI (EA) 10193489484632, UDI/DI (CS)40193489484633;  l) Model Number CDS984642, UDI/DI (EA) 10884389882924, UDI/DI (CS)40884389882925;  m) Model Number CDS984764G, UDI/DI (EA) 10193489450293, UDI/DI (CS)40193489450294;  n) Model Number CDS985105O, UDI/DI (EA) 10195327036249, UDI/DI (CS)40195327036240;  o) Model Number CDS985355D, UDI/DI (EA) 10193489442779, UDI/DI (CS)40193489442770;  p) Model Number CDS985355F, UDI/DI (EA) 10195327242626, UDI/DI (CS)40195327242627;  q) Model Number CVI4955, UDI/DI (EA) 10195327325848, UDI/DI (CS)40195327325849;  r) Model Number DYKMBNDL21, UDI/DI (EA) 10193489478693, UDI/DI (CS)40193489478694;  s) Model Number DYNDA2526, UDI/DI (EA) 10193489191790, UDI/DI (CS)40193489191791;  t) Model Number DYNDC3038, UDI/DI (EA) 10193489493603, UDI/DI (CS)40193489493604;  u) Model Number DYNJ0037939B, UDI/DI (EA) 10195327031275, UDI/DI (CS)40195327031276;  v) Model Number DYNJ0149567C, UDI/DI (EA) 10195327235529, UDI/DI (CS)40195327235520;  w) Model Number DYNJ0201109AJ, UDI/DI (EA) 10195327325459, UDI/DI (CS)40195327325450;  x) Model Number DYNJ0371669N, UDI/DI (EA) 10193489230390, UDI/DI (CS)40193489230391;  y) Model Number DYNJ0408782AA, UDI/DI (EA) 10195327115814, UDI/DI (CS)40195327115815;  z) Model Number DYNJ0429185K, UDI/DI (EA) 10193489728132, UDI/DI (CS)40193489728133;  aa) Model Number DYNJ0429185M, UDI/DI (EA) 10195327371357, UDI/DI (CS)40195327371358;  bb) Model Number DYNJ0450131AI, UDI/DI (EA) 10193489466126, UDI/DI (CS)40193489466127;  cc) Model Number DYNJ0493141J, UDI/DI (EA) 10193489926224, UDI/DI (CS)40193489926225;  dd) Model Number DYNJ0565558U, UDI/DI (EA) 10193489827033, UDI/DI (CS)40193489827034;  ee) Model Number DYNJ0676055N, UDI/DI (EA) 10193489954364, UDI/DI (CS)40193489954365;  ff) Model Number DYNJ0678934G, UDI/DI (EA) 10193489925265, UDI/DI (CS)40193489925266;  gg) Model Number DYNJ0678934I, UDI/DI (EA) 10193489997866, UDI/DI (CS)40193489997867;  hh) Model Number DYNJ0785736J, UDI/DI (EA) 10193489202663, UDI/DI (CS)40193489202664;  ii) Model Number DYNJ0842825D, UDI/DI (EA) 10195327288617, UDI/DI (CS)40195327288618;  jj) Model Number DYNJ0871182AC, UDI/DI (EA) 10195327330859, UDI/DI (CS)40195327330850;  kk) Model Number DYNJ09878D, UDI/DI (EA) 10195327387662, UDI/DI (CS)40195327387663;  ll) Model Number DYNJ16618J, UDI/DI (EA) 10195327249854, UDI/DI (CS)40195327249855;  mm) Model Number DYNJ16618K, UDI/DI (EA) 10195327325572, UDI/DI (CS)40195327325573;  nn) Model Number DYNJ20031C, UDI/DI (EA) 10884389650073, UDI/DI (CS)40884389650074;  oo) Model Number DYNJ21949J, UDI/DI (EA) 10889942128419, UDI/DI (CS)40889942128410;  pp) Model Number DYNJ22350L, UDI/DI (EA) 10193489445251, UDI/DI (CS)40193489445252;  qq) Model Number DYNJ23456K, UDI/DI (EA) 10193489967760, UDI/DI (CS)40193489967761;  rr) Model Number DYNJ24272C, UDI/DI (EA) 10193489620221, UDI/DI (CS)40193489620222;  ss) Model Number DYNJ25749S, UDI/DI (EA) 10195327059705, UDI/DI (CS)40195327059706;  tt) Model Number DYNJ28849B, UDI/DI (EA) 10195327319557, UDI/DI (CS)40195327319558;  uu) Model Number DYNJ31928D, UDI/DI (EA) 10195327335281, UDI/DI (CS)40195327335282;  vv) Model Number DYNJ34844C, UDI/DI (EA) 10193489778076, UDI/DI (CS)40193489778077;  ww) Model Number DYNJ35495G, UDI/DI (EA) 10193489803990, UDI/DI (CS)40193489803991;  xx) Model Number DYNJ35578G, UDI/DI (EA) 10193489808605, UDI/DI (CS)40193489808606;  yy) Model Number DYNJ36052O, UDI/DI (EA) 10195327249533, UDI/DI (CS)40195327249534;  zz) Model Number DYNJ37445I, UDI/DI (EA) 10193489417395, UDI/DI (CS)40193489417396;  aaa) Model Number DYNJ38264D, UDI/DI (EA) 10193489438499, UDI/DI (CS)40193489438490;  bbb) Model Number DYNJ38756B, UDI/DI (EA) 10889942455799, UDI/DI (CS)40889942455790;  ccc) Model Number DYNJ38995C, UDI/DI (EA) 10193489713145, UDI/DI (CS)40193489713146;  ddd) Model Number DYNJ39408F, UDI/DI (EA) 10193489692839, UDI/DI (CS)40193489692830;  eee) Model Number DYNJ39488G, UDI/DI (EA) 10193489383775, UDI/DI (CS)40193489383776;  fff) Model Number DYNJ39889, UDI/DI (EA) 10884389796931, UDI/DI (CS)40884389796932;  ggg) Model Number DYNJ40067G, UDI/DI (EA) 10195327244033, UDI/DI (CS)40195327244034;  hhh) Model Number DYNJ40077F, UDI/DI (EA) 10195327175818, UDI/DI (CS)40195327175819;  iii) Model Number DYNJ40108I, UDI/DI (EA) 10195327284183, UDI/DI (CS)40195327284184;  jjj) Model Number DYNJ40215C, UDI/DI (EA) 10195327176501, UDI/DI (CS)40195327176502;  kkk) Model Number DYNJ40379D, UDI/DI (EA) 10193489257618, UDI/DI (CS)40193489257619;  lll) Model Number DYNJ41100C, UDI/DI (EA) 10193489899825, UDI/DI (CS)40193489899826;  mmm) Model Number DYNJ41195D, UDI/DI (EA) 10193489314250, UDI/DI (CS)40193489314251;  nnn) Model Number DYNJ42976, UDI/DI (EA) 10888277019140, UDI/DI (CS)40888277019141;  ooo) Model Number DYNJ43085A, UDI/DI (EA) 10193489600346, UDI/DI (CS)40193489600347;  ppp) Model Number DYNJ43922, UDI/DI (EA) 10888277074668, UDI/DI (CS)40888277074669;  qqq) Model Number DYNJ44087B, UDI/DI (EA) 10195327346584, UDI/DI (CS)40195327346585;  rrr) Model Number DYNJ44345F, UDI/DI (EA) 10889942966523, UDI/DI (CS)40889942966524;  sss) Model Number DYNJ44345G, UDI/DI (EA) 10193489939507, UDI/DI (CS)40193489939508;  ttt) Model Number DYNJ44421D, UDI/DI (EA) 10193489482638, UDI/DI (CS)40193489482639;  uuu) Model Number DYNJ44737B, UDI/DI (EA) 10193489351712, UDI/DI (CS)40193489351713;  vvv) Model Number DYNJ44808G, UDI/DI (EA) 10193489875850, UDI/DI (CS)40193489875851;  www) Model Number DYNJ45074C, UDI/DI (EA) 10193489222678, UDI/DI (CS)40193489222679;  xxx) Model Number DYNJ46246A, UDI/DI (EA) 10889942584963, UDI/DI (CS)40889942584964;  yyy) Model Number DYNJ46359D, UDI/DI (EA) 10193489961379, UDI/DI (CS)40193489961370;  zzz) Model Number DYNJ47138B, UDI/DI (EA) 10889942274215, UDI/DI (CS)40889942274216;  aaaa) Model Number DYNJ47645C, UDI/DI (EA) 10195327355173, UDI/DI (CS)40195327355174;  bbbb) Model Number DYNJ47660K, UDI/DI (EA) 10193489875737, UDI/DI (CS)40193489875738;  cccc) Model Number DYNJ48365, UDI/DI (EA) 10888277594593, UDI/DI (CS)40888277594594;  dddd) Model Number DYNJ48456C, UDI/DI (EA) 10195327015862, UDI/DI (CS)40195327015863;  eeee) Model Number DYNJ48907F, UDI/DI (EA) 10889942529421, UDI/DI (CS)40889942529422;  ffff) Model Number DYNJ49874, UDI/DI (EA) 10888277890602, UDI/DI (CS)40888277890603;  gggg) Model Number DYNJ49931I, UDI/DI (EA) 10193489939217, UDI/DI (CS)40193489939218;  hhhh) Model Number DYNJ49933I, UDI/DI (EA) 10193489471687, UDI/DI (CS)40193489471688;  iiii) Model Number DYNJ49933J, UDI/DI (EA) 10195327065614, UDI/DI (CS)40195327065615;  jjjj) Model Number DYNJ50227C, UDI/DI (EA) 10889942938612, UDI/DI (CS)40889942938613;  kkkk) Model Number DYNJ50785, UDI/DI (EA) 10889942105304, UDI/DI (CS)40889942105305;  llll) Model Number DYNJ51304C, UDI/DI (EA) 10193489460988, UDI/DI (CS)40193489460989;  mmmm) Model Number DYNJ51925F, UDI/DI (EA) 10195327153397, UDI/DI (CS)40195327153398;  nnnn) Model Number DYNJ52024, UDI/DI (EA) 10889942233359, UDI/DI (CS)40889942233350;  oooo) Model Number DYNJ52056C, UDI/DI (EA) 10193489369441, UDI/DI (CS)40193489369442;  pppp) Model Number DYNJ52056D, UDI/DI (EA) 10195327096137, UDI/DI (CS)40195327096138;  qqqq) Model Number DYNJ52098, UDI/DI (EA) 10889942237067, UDI/DI (CS)40889942237068;  rrrr) Model Number DYNJ52586A, UDI/DI (EA) 10193489494396, UDI/DI (CS)40193489494397;  ssss) Model Number DYNJ52586B, UDI/DI (EA) 10195327212117, UDI/DI (CS)40195327212118;  tttt) Model Number DYNJ52606F, UDI/DI (EA) 10193489343298, UDI/DI (CS)40193489343299;  uuuu) Model Number DYNJ52756A, UDI/DI (EA) 10193489413830, UDI/DI (CS)40193489413831;  vvvv) Model Number DYNJ52766A, UDI/DI (EA) 10193489292367, UDI/DI (CS)40193489292368;  wwww) Model Number DYNJ53433F, UDI/DI (EA) 10193489328677, UDI/DI (CS)40193489328678;  xxxx) Model Number DYNJ53433G, UDI/DI (EA) 10195327042431, UDI/DI (CS)40195327042432;  yyyy) Model Number DYNJ53433I, UDI/DI (EA) 10195327074494, UDI/DI (CS)40195327074495;  zzzz)   Model Number DYNJ53433J, UDI/DI (EA) 10195327222925, UDI/DI (CS)40195327222926;. 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-2163-2023&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-2163-2023&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-2163-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2163-2023 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-2163-2023&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-2163-2023&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-2163-2023/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."
    }
  ],
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2163-2023",
      "numberOfItems": 9,
      "itemListElement": [
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2163-2023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-18",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
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 ttt) Model Number DYNJ44421D, UDI/DI (EA) 10193489482638, UDI/DI (CS)40193489482639;  uuu) Model Number DYNJ44737B, UDI/DI (EA) 10193489351712, UDI/DI (CS)40193489351713;  vvv) Model Number DYNJ44808G, UDI/DI (EA) 10193489875850, UDI/DI (CS)40193489875851;  www) Model Number DYNJ45074C, UDI/DI (EA) 10193489222678, UDI/DI (CS)40193489222679;  xxx) Model Number DYNJ46246A, UDI/DI (EA) 10889942584963, UDI/DI (CS)40889942584964;  yyy) Model Number DYNJ46359D, UDI/DI (EA) 10193489961379, UDI/DI (CS)40193489961370;  zzz) Model Number DYNJ47138B, UDI/DI (EA) 10889942274215, UDI/DI (CS)40889942274216;  aaaa) Model Number DYNJ47645C, UDI/DI (EA) 10195327355173, UDI/DI (CS)40195327355174;  bbbb) Model Number DYNJ47660K, UDI/DI (EA) 10193489875737, UDI/DI (CS)40193489875738;  cccc) Model Number DYNJ48365, UDI/DI (EA) 10888277594593, UDI/DI (CS)40888277594594;  dddd) Model Number DYNJ48456C, UDI/DI (EA) 10195327015862, UDI/DI (CS)40195327015863;  eeee) Model Number DYNJ48907F, UDI/DI (EA) 10889942529421, UDI/DI (CS)40889942529422; 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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"
          }
        }
      ]
    }
  ]
}