{
  "@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-2205-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tTOTAL JOINT, Model Number CDS985555S;   b)\tTOTAL KNEE, Model Number CDS985566Q;   c)\tMAJOR ORTHO-LF, Model Number DYNJ0949139I;   d)\tBSHR TOTAL KNEE-LF, Model Number DYNJ24525K;   e)\tBSHR TOTAL HIP-LF, Model Number DYNJ24526P;   f)\tTOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L;   g)\tTOTAL KNEE PACK 319735, Model Number DYNJ44635I;   h)\tHIP ARTHROPLASTY PACK, Model Number DYNJ50072F;   i)\tLEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L;   j)\tTOTAL JOINT, Model Number DYNJ57827D;   k)\tANTERIOR HIP PACK, Model Number DYNJ59126B;   l)\tTOTAL HIP PACK, Model Number DYNJ60918A;   m)\tMAIN TOTAL JOINT, Model Number DYNJ61376C;   n)\tTOTAL HIP PACK, Model Number DYNJ63383;   o)\tANTERIOR PACK, Model Number DYNJ64814A;   p)\tTOTAL JOINT PACK, Model Number DYNJ64951;   q)\tTOTAL KNEE PACK-EOSC, Model Number DYNJ65093B;   r)\tTOTAL KNEE PACK-CSC, Model Number DYNJ65108F;   s)\tMERCY ANTERIOR HIP, Model Number DYNJ66913A;   t)\tTOTAL PACK, Model Number DYNJ68468C;   u)\tTOTAL KNEE-LF, Model Number DYNJ69153F;   v)\tTOTAL JOINT PACK, Model Number DYNJ80372B;   w)\tANTERIOR HIP PACK, Model Number DYNJ82038;   x)\tHIP PACK, Model Number DYNJ82345A;   y)\tTOTAL HIP PACK, Model Number DYNJ82627A;   z)\tTOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553;   aa)\tTOTAL JOINT PACK, Model Number DYNJ83567A;   bb)\tTOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885;   cc)\tHIP PACK, Model Number DYNJ84051;   dd)\tTOTAL KNEE PACK, Model Number DYNJ84054;   ee)\tOISC HAND KORCEK, Model Number DYNJ902351F;   ff)\tTOTAL HIP, Model Number DYNJ903149D;   gg)\tOISC TOTAL HIP BOTTROS, Model Number DYNJ904154O;   hh)\tTOTAL HIP, Model Number DYNJ904331I;   ii)\tTOTAL KNEE, Model Number DYNJ904332J;   jj)\tCRANIOTOMY, Model Number DYNJ905330B;   kk)\tTRAUMA-RAMA, Model Number DYNJ905886G;   ll)\tANTERIOR HIP, Model Number DYNJ907831D;   mm)\tTOTAL HIP-LF, Model Number DYNJ908127B;   nn)\tTOTAL KNEE-LF, Model Number DYNJ908128B;   oo)\tTOTAL HIP CDS, Model Number DYNJ908331A;   pp)\tTOTAL KNEE THEDA, Model Number DYNJ908683A;   qq)\tTOTAL HIP-LF, Model Number DYNJ909000;   rr)\tTOTAL KNEE-LF, Model Number DYNJ909002;   ss)\tTOTAL HIP, Model Number DYNJ909198A;   tt)\tHIP MOFFIT PPS-LF, Model Number DYNJ9428703Q;   uu)\tLOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R;   vv)\tUPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O",
  "description": "FDA recall Z-2205-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tTOTAL JOINT, Model Number CDS985555S;   b)\tTOTAL KNEE, Model Number CDS985566Q;   c)\tMAJOR ORTHO-LF, Model Number DYNJ0949139I;   d)\tBSHR TOTAL KNEE-LF, Model Number DYNJ24525K;   e)\tBSHR TOTAL HIP-LF, Model Number DYNJ24526P;   f)\tTOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L;   g)\tTOTAL KNEE PACK 319735, Model Number DYNJ44635I;   h)\tHIP ARTHROPLASTY PACK, Model Number DYNJ50072F;   i)\tLEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L;   j)\tTOTAL JOINT, Model Number DYNJ57827D;   k)\tANTERIOR HIP PACK, Model Number DYNJ59126B;   l)\tTOTAL HIP PACK, Model Number DYNJ60918A;   m)\tMAIN TOTAL JOINT, Model Number DYNJ61376C;   n)\tTOTAL HIP PACK, Model Number DYNJ63383;   o)\tANTERIOR PACK, Model Number DYNJ64814A;   p)\tTOTAL JOINT PACK, Model Number DYNJ64951;   q)\tTOTAL KNEE PACK-EOSC, Model Number DYNJ65093B;   r)\tTOTAL KNEE PACK-CSC, Model Number DYNJ65108F;   s)\tMERCY ANTERIOR HIP, Model Number DYNJ66913A;   t)\tTOTAL PACK, Model Number DYNJ68468C;   u)\tTOTAL KNEE-LF, Model Number DYNJ69153F;   v)\tTOTAL JOINT PACK, Model Number DYNJ80372B;   w)\tANTERIOR HIP PACK, Model Number DYNJ82038;   x)\tHIP PACK, Model Number DYNJ82345A;   y)\tTOTAL HIP PACK, Model Number DYNJ82627A;   z)\tTOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553;   aa)\tTOTAL JOINT PACK, Model Number DYNJ83567A;   bb)\tTOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885;   cc)\tHIP PACK, Model Number DYNJ84051;   dd)\tTOTAL KNEE PACK, Model Number DYNJ84054;   ee)\tOISC HAND KORCEK, Model Number DYNJ902351F;   ff)\tTOTAL HIP, Model Number DYNJ903149D;   gg)\tOISC TOTAL HIP BOTTROS, Model Number DYNJ904154O;   hh)\tTOTAL HIP, Model Number DYNJ904331I;   ii)\tTOTAL KNEE, Model Number DYNJ904332J;   jj)\tCRANIOTOMY, Model Number DYNJ905330B;   kk)\tTRAUMA-RAMA, Model Number DYNJ905886G;   ll)\tANTERIOR HIP, Model Number DYNJ907831D;   mm)\tTOTAL HIP-LF, Model Number DYNJ908127B;   nn)\tTOTAL KNEE-LF, Model Number DYNJ908128B;   oo)\tTOTAL HIP CDS, Model Number DYNJ908331A;   pp)\tTOTAL KNEE THEDA, Model Number DYNJ908683A;   qq)\tTOTAL HIP-LF, Model Number DYNJ909000;   rr)\tTOTAL KNEE-LF, Model Number DYNJ909002;   ss)\tTOTAL HIP, Model Number DYNJ909198A;   tt)\tHIP MOFFIT PPS-LF, Model Number DYNJ9428703Q;   uu)\tLOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R;   vv)\tUPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O (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-2205-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tTOTAL JOINT, Model Number CDS985555S;   b)\tTOTAL KNEE, Model Number CDS985566Q;   c)\tMAJOR ORTHO-LF, Model Number DYNJ0949139I;   d)\tBSHR TOTAL KNEE-LF, Model Number DYNJ24525K;   e)\tBSHR TOTAL HIP-LF, Model Number DYNJ24526P;   f)\tTOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L;   g)\tTOTAL KNEE PACK 319735, Model Number DYNJ44635I;   h)\tHIP ARTHROPLASTY PACK, Model Number DYNJ50072F;   i)\tLEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L;   j)\tTOTAL JOINT, Model Number DYNJ57827D;   k)\tANTERIOR HIP PACK, Model Number DYNJ59126B;   l)\tTOTAL HIP PACK, Model Number DYNJ60918A;   m)\tMAIN TOTAL JOINT, Model Number DYNJ61376C;   n)\tTOTAL HIP PACK, Model Number DYNJ63383;   o)\tANTERIOR PACK, Model Number DYNJ64814A;   p)\tTOTAL JOINT PACK, Model Number DYNJ64951;   q)\tTOTAL KNEE PACK-EOSC, Model Number DYNJ65093B;   r)\tTOTAL KNEE PACK-CSC, Model Number DYNJ65108F;   s)\tMERCY ANTERIOR HIP, Model Number DYNJ66913A;   t)\tTOTAL PACK, Model Number DYNJ68468C;   u)\tTOTAL KNEE-LF, Model Number DYNJ69153F;   v)\tTOTAL JOINT PACK, Model Number DYNJ80372B;   w)\tANTERIOR HIP PACK, Model Number DYNJ82038;   x)\tHIP PACK, Model Number DYNJ82345A;   y)\tTOTAL HIP PACK, Model Number DYNJ82627A;   z)\tTOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553;   aa)\tTOTAL JOINT PACK, Model Number DYNJ83567A;   bb)\tTOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885;   cc)\tHIP PACK, Model Number DYNJ84051;   dd)\tTOTAL KNEE PACK, Model Number DYNJ84054;   ee)\tOISC HAND KORCEK, Model Number DYNJ902351F;   ff)\tTOTAL HIP, Model Number DYNJ903149D;   gg)\tOISC TOTAL HIP BOTTROS, Model Number DYNJ904154O;   hh)\tTOTAL HIP, Model Number DYNJ904331I;   ii)\tTOTAL KNEE, Model Number DYNJ904332J;   jj)\tCRANIOTOMY, Model Number DYNJ905330B;   kk)\tTRAUMA-RAMA, Model Number DYNJ905886G;   ll)\tANTERIOR HIP, Model Number DYNJ907831D;   mm)\tTOTAL HIP-LF, Model Number DYNJ908127B;   nn)\tTOTAL KNEE-LF, Model Number DYNJ908128B;   oo)\tTOTAL HIP CDS, Model Number DYNJ908331A;   pp)\tTOTAL KNEE THEDA, Model Number DYNJ908683A;   qq)\tTOTAL HIP-LF, Model Number DYNJ909000;   rr)\tTOTAL KNEE-LF, Model Number DYNJ909002;   ss)\tTOTAL HIP, Model Number DYNJ909198A;   tt)\tHIP MOFFIT PPS-LF, Model Number DYNJ9428703Q;   uu)\tLOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R;   vv)\tUPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2205-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2205-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tTOTAL JOINT, Model Number CDS985555S;   b)\tTOTAL KNEE, Model Number CDS985566Q;   c)\tMAJOR ORTHO-LF, Model Number DYNJ0949139I;   d)\tBSHR TOTAL KNEE-LF, Model Number DYNJ24525K;   e)\tBSHR TOTAL HIP-LF, Model Number DYNJ24526P;   f)\tTOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L;   g)\tTOTAL KNEE PACK 319735, Model Number DYNJ44635I;   h)\tHIP ARTHROPLASTY PACK, Model Number DYNJ50072F;   i)\tLEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L;   j)\tTOTAL JOINT, Model Number DYNJ57827D;   k)\tANTERIOR HIP PACK, Model Number DYNJ59126B;   l)\tTOTAL HIP PACK, Model Number DYNJ60918A;   m)\tMAIN TOTAL JOINT, Model Number DYNJ61376C;   n)\tTOTAL HIP PACK, Model Number DYNJ63383;   o)\tANTERIOR PACK, Model Number DYNJ64814A;   p)\tTOTAL JOINT PACK, Model Number DYNJ64951;   q)\tTOTAL KNEE PACK-EOSC, Model Number DYNJ65093B;   r)\tTOTAL KNEE PACK-CSC, Model Number DYNJ65108F;   s)\tMERCY ANTERIOR HIP, Model Number DYNJ66913A;   t)\tTOTAL PACK, Model Number DYNJ68468C;   u)\tTOTAL KNEE-LF, Model Number DYNJ69153F;   v)\tTOTAL JOINT PACK, Model Number DYNJ80372B;   w)\tANTERIOR HIP PACK, Model Number DYNJ82038;   x)\tHIP PACK, Model Number DYNJ82345A;   y)\tTOTAL HIP PACK, Model Number DYNJ82627A;   z)\tTOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553;   aa)\tTOTAL JOINT PACK, Model Number DYNJ83567A;   bb)\tTOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885;   cc)\tHIP PACK, Model Number DYNJ84051;   dd)\tTOTAL KNEE PACK, Model Number DYNJ84054;   ee)\tOISC HAND KORCEK, Model Number DYNJ902351F;   ff)\tTOTAL HIP, Model Number DYNJ903149D;   gg)\tOISC TOTAL HIP BOTTROS, Model Number DYNJ904154O;   hh)\tTOTAL HIP, Model Number DYNJ904331I;   ii)\tTOTAL KNEE, Model Number DYNJ904332J;   jj)\tCRANIOTOMY, Model Number DYNJ905330B;   kk)\tTRAUMA-RAMA, Model Number DYNJ905886G;   ll)\tANTERIOR HIP, Model Number DYNJ907831D;   mm)\tTOTAL HIP-LF, Model Number DYNJ908127B;   nn)\tTOTAL KNEE-LF, Model Number DYNJ908128B;   oo)\tTOTAL HIP CDS, Model Number DYNJ908331A;   pp)\tTOTAL KNEE THEDA, Model Number DYNJ908683A;   qq)\tTOTAL HIP-LF, Model Number DYNJ909000;   rr)\tTOTAL KNEE-LF, Model Number DYNJ909002;   ss)\tTOTAL HIP, Model Number DYNJ909198A;   tt)\tHIP MOFFIT PPS-LF, Model Number DYNJ9428703Q;   uu)\tLOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R;   vv)\tUPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O",
      "text": "The FDA logged enforcement record Z-2205-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tTOTAL JOINT, Model Number CDS985555S;   b)\tTOTAL KNEE, Model Number CDS985566Q;   c)\tMAJOR ORTHO-LF, Model Number DYNJ0949139I;   d)\tBSHR TOTAL KNEE-LF, Model Number DYNJ24525K;   e)\tBSHR TOTAL HIP-LF, Model Number DYNJ24526P;   f)\tTOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L;   g)\tTOTAL KNEE PACK 319735, Model Number DYNJ44635I;   h)\tHIP ARTHROPLASTY PACK, Model Number DYNJ50072F;   i)\tLEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L;   j)\tTOTAL JOINT, Model Number DYNJ57827D;   k)\tANTERIOR HIP PACK, Model Number DYNJ59126B;   l)\tTOTAL HIP PACK, Model Number DYNJ60918A;   m)\tMAIN TOTAL JOINT, Model Number DYNJ61376C;   n)\tTOTAL HIP PACK, Model Number DYNJ63383;   o)\tANTERIOR PACK, Model Number DYNJ64814A;   p)\tTOTAL JOINT PACK, Model Number DYNJ64951;   q)\tTOTAL KNEE PACK-EOSC, Model Number DYNJ65093B;   r)\tTOTAL KNEE PACK-CSC, Model Number DYNJ65108F;   s)\tMERCY ANTERIOR HIP, Model Number DYNJ66913A;   t)\tTOTAL PACK, Model Number DYNJ68468C;   u)\tTOTAL KNEE-LF, Model Number DYNJ69153F;   v)\tTOTAL JOINT PACK, Model Number DYNJ80372B;   w)\tANTERIOR HIP PACK, Model Number DYNJ82038;   x)\tHIP PACK, Model Number DYNJ82345A;   y)\tTOTAL HIP PACK, Model Number DYNJ82627A;   z)\tTOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553;   aa)\tTOTAL JOINT PACK, Model Number DYNJ83567A;   bb)\tTOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885;   cc)\tHIP PACK, Model Number DYNJ84051;   dd)\tTOTAL KNEE PACK, Model Number DYNJ84054;   ee)\tOISC HAND KORCEK, Model Number DYNJ902351F;   ff)\tTOTAL HIP, Model Number DYNJ903149D;   gg)\tOISC TOTAL HIP BOTTROS, Model Number DYNJ904154O;   hh)\tTOTAL HIP, Model Number DYNJ904331I;   ii)\tTOTAL KNEE, Model Number DYNJ904332J;   jj)\tCRANIOTOMY, Model Number DYNJ905330B;   kk)\tTRAUMA-RAMA, Model Number DYNJ905886G;   ll)\tANTERIOR HIP, Model Number DYNJ907831D;   mm)\tTOTAL HIP-LF, Model Number DYNJ908127B;   nn)\tTOTAL KNEE-LF, Model Number DYNJ908128B;   oo)\tTOTAL HIP CDS, Model Number DYNJ908331A;   pp)\tTOTAL KNEE THEDA, Model Number DYNJ908683A;   qq)\tTOTAL HIP-LF, Model Number DYNJ909000;   rr)\tTOTAL KNEE-LF, Model Number DYNJ909002;   ss)\tTOTAL HIP, Model Number DYNJ909198A;   tt)\tHIP MOFFIT PPS-LF, Model Number DYNJ9428703Q;   uu)\tLOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R;   vv)\tUPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O — 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: a) Model Number CDS985555S, UDI/DI (EA) 10195327343798, UDI/DI (CS) 40195327343799;  b) Model Number CDS985566Q, UDI/DI (EA) 10195327074418, UDI/DI (CS) 40195327074419;  c) Model Number DYNJ0949139I, UDI/DI (EA) 10195327195366, UDI/DI (CS) 40195327195367;  d) Model Number DYNJ24525K, UDI/DI (EA) 10195327135751, UDI/DI (CS) 40195327135752;  e) Model Number DYNJ24526P, UDI/DI (EA) 10195327135744, UDI/DI (CS) 40195327135745;  f) Model Number DYNJ26425L, UDI/DI (EA) 10195327156985, UDI/DI (CS) 40195327156986;  g) Model Number DYNJ44635I, UDI/DI (EA) 10193489958553, UDI/DI (CS) 40193489958554;  h) Model Number DYNJ50072F, UDI/DI (EA) 10193489340921, UDI/DI (CS) 40193489340922;  i) Model Number DYNJ55655L, UDI/DI (EA) 10195327102029, UDI/DI (CS) 40195327102020;  j) Model Number DYNJ57827D, UDI/DI (EA) 10193489910636, UDI/DI (CS) 40193489920637;  k) Model Number DYNJ59126B, UDI/DI (EA) 10193489395983, UDI/DI (CS) 40193489395984;  l) Model Number DYNJ60918A, UDI/DI (EA) 10193489257946, UDI/DI (CS) 40193489257947;  m) Model Number DYNJ61376C, UDI/DI (EA) 10195327295066, UDI/DI (CS) 40195327295067;  n) Model Number DYNJ63383, UDI/DI (EA) 10193489735109, UDI/DI (CS) 40193489735100;  o) Model Number DYNJ64814A, UDI/DI (EA) 10195327112806, UDI/DI (CS) 40195327112807;  p) Model Number DYNJ64951, UDI/DI (EA) 10193489236224, UDI/DI (CS) 40193489236225;  q) Model Number DYNJ65093B, UDI/DI (EA) 10195327177508, UDI/DI (CS) 40195327177509;  r) Model Number DYNJ65108F, UDI/DI (EA) 10195327256241, UDI/DI (CS) 40195327256242;  s) Model Number DYNJ66913A, UDI/DI (EA) 10193489996234, UDI/DI (CS) 40193489996235;  t) Model Number DYNJ68468C, UDI/DI (EA) 10195327097370, UDI/DI (CS) 40195327097371;  u) Model Number DYNJ69153F, UDI/DI (EA) 10195327332679, UDI/DI (CS) 40195327332670;  v) Model Number DYNJ80372B, UDI/DI (EA) 10195327244156, UDI/DI (CS) 40195327244157;  w) Model Number DYNJ82038, UDI/DI (EA) 10195327163372, UDI/DI (CS) 40195327163373;  x) Model Number DYNJ82345A, UDI/DI (EA) 10195327216556, UDI/DI (CS) 40195327316557;  y) Model Number DYNJ82627A, UDI/DI (EA) 10195327333331, UDI/DI (CS) 40195327333332;  z) Model Number DYNJ83553, UDI/DI (EA) 10195327279356, UDI/DI (CS) 40195327279357;  aa) Model Number DYNJ83567A, UDI/DI (EA) 10195327343033, UDI/DI (CS) 40195327343034;  bb) Model Number DYNJ83885, UDI/DI (EA) 10195327312237, UDI/DI (CS) 40195327312238;  cc) Model Number DYNJ84051, UDI/DI (EA) 10195327330316, UDI/DI (CS) 40195327330317;  dd) Model Number DYNJ84054, UDI/DI (EA) 10195327330347, UDI/DI (CS) 40195327330348;  ee) Model Number DYNJ902351F, UDI/DI (EA) 10195327318420, UDI/DI (CS) 40195327318421;  ff) Model Number DYNJ903149D, UDI/DI (EA) 10195327271139, UDI/DI (CS) 40195327261130;  gg) Model Number DYNJ904154O, UDI/DI (EA) 10195327318604, UDI/DI (CS) 40195327318605;  hh) Model Number DYNJ904331I, UDI/DI (EA) 10195327025700, UDI/DI (CS) 40195327025701;  ii) Model Number DYNJ904332J, UDI/DI (EA) 10195327025694, UDI/DI (CS) 40195327025695;  jj) Model Number DYNJ905330B, UDI/DI (EA) 10193489781502, UDI/DI (CS) 40193489781503;  kk) Model Number DYNJ905886G, UDI/DI (EA) 10195327329167, UDI/DI (CS) 40195327329168;  ll) Model Number DYNJ907831D, UDI/DI (EA) 10195327239701, UDI/DI (CS) 40195327239702;  mm) Model Number DYNJ908127B, UDI/DI (EA) 10195327349929, UDI/DI (CS) 40195327349920;  nn) Model Number DYNJ908128B, UDI/DI (EA) 10195327349912, UDI/DI (CS) 40195327349913;  oo) Model Number DYNJ908331A, UDI/DI (EA) 10195327190156, UDI/DI (CS) 40195327190157;  pp) Model Number DYNJ908683A, UDI/DI (EA) 10195327251772, UDI/DI (CS) 40195327251773;  qq) Model Number DYNJ909000, UDI/DI (EA) 10195327238100, UDI/DI (CS) 40195327238101;  rr) Model Number DYNJ909002, UDI/DI (EA) 10195327238148, UDI/DI (CS) 40195327238149;  ss) Model Number DYNJ909198A, UDI/DI (EA) 10195327414788, UDI/DI (CS) 40195327414789;  tt) Model Number DYNJ9428703Q, UDI/DI (EA) 10195327329174, UDI/DI (CS) 40195327329175;  uu) Model Number DYNJ9428745R, UDI/DI (EA) 10195327258368, UDI/DI (CS) 40195327258369;  vv) Model Number DYNJ9428787O, UDI/DI (EA) 10195327328795, UDI/DI (CS) 40195327328795;  All lots within expiry, distributed from Medline between December 2017 - May 2023:. 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-2205-2023&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-2205-2023&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-2205-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2205-2023 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-2205-2023&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-2205-2023&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-2205-2023/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-2205-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2205-2023",
            "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": "a) Model Number CDS985555S, UDI/DI (EA) 10195327343798, UDI/DI (CS) 40195327343799;  b) Model Number CDS985566Q, UDI/DI (EA) 10195327074418, UDI/DI (CS) 40195327074419;  c) Model Number DYNJ0949139I, UDI/DI (EA) 10195327195366, UDI/DI (CS) 40195327195367;  d) Model Number DYNJ24525K, UDI/DI (EA) 10195327135751, UDI/DI (CS) 40195327135752;  e) Model Number DYNJ24526P, UDI/DI (EA) 10195327135744, UDI/DI (CS) 40195327135745;  f) Model Number DYNJ26425L, UDI/DI (EA) 10195327156985, UDI/DI (CS) 40195327156986;  g) Model Number DYNJ44635I, UDI/DI (EA) 10193489958553, UDI/DI (CS) 40193489958554;  h) Model Number DYNJ50072F, UDI/DI (EA) 10193489340921, UDI/DI (CS) 40193489340922;  i) Model Number DYNJ55655L, UDI/DI (EA) 10195327102029, UDI/DI (CS) 40195327102020;  j) Model Number DYNJ57827D, UDI/DI (EA) 10193489910636, UDI/DI (CS) 40193489920637;  k) Model Number DYNJ59126B, UDI/DI (EA) 10193489395983, UDI/DI (CS) 40193489395984;  l) Model Number DYNJ60918A, UDI/DI (EA) 10193489257946, UDI/DI (CS) 40193489257947;  m) Model Number DYNJ61376C, UDI/DI (EA) 10195327295066, UDI/DI (CS) 40195327295067;  n) Model Number DYNJ63383, UDI/DI (EA) 10193489735109, UDI/DI (CS) 40193489735100;  o) Model Number DYNJ64814A, UDI/DI (EA) 10195327112806, UDI/DI (CS) 40195327112807;  p) Model Number DYNJ64951, UDI/DI (EA) 10193489236224, UDI/DI (CS) 40193489236225;  q) Model Number DYNJ65093B, UDI/DI (EA) 10195327177508, UDI/DI (CS) 40195327177509;  r) Model Number DYNJ65108F, UDI/DI (EA) 10195327256241, UDI/DI (CS) 40195327256242;  s) Model Number DYNJ66913A, UDI/DI (EA) 10193489996234, UDI/DI (CS) 40193489996235;  t) Model Number DYNJ68468C, UDI/DI (EA) 10195327097370, UDI/DI (CS) 40195327097371;  u) Model Number DYNJ69153F, UDI/DI (EA) 10195327332679, UDI/DI (CS) 40195327332670;  v) Model Number DYNJ80372B, UDI/DI (EA) 10195327244156, UDI/DI (CS) 40195327244157;  w) Model Number DYNJ82038, UDI/DI (EA) 10195327163372, UDI/DI (CS) 40195327163373;  x) Model Number DYNJ82345A, UDI/DI (EA) 10195327216556, UDI/DI (CS) 40195327316557;  y) Model Number DYNJ82627A, UDI/DI (EA) 10195327333331, UDI/DI (CS) 40195327333332;  z) Model Number DYNJ83553, UDI/DI (EA) 10195327279356, UDI/DI (CS) 40195327279357;  aa) Model Number DYNJ83567A, UDI/DI (EA) 10195327343033, UDI/DI (CS) 40195327343034;  bb) Model Number DYNJ83885, UDI/DI (EA) 10195327312237, UDI/DI (CS) 40195327312238;  cc) Model Number DYNJ84051, UDI/DI (EA) 10195327330316, UDI/DI (CS) 40195327330317;  dd) Model Number DYNJ84054, UDI/DI (EA) 10195327330347, UDI/DI (CS) 40195327330348;  ee) Model Number DYNJ902351F, UDI/DI (EA) 10195327318420, UDI/DI (CS) 40195327318421;  ff) Model Number DYNJ903149D, UDI/DI (EA) 10195327271139, UDI/DI (CS) 40195327261130;  gg) Model Number DYNJ904154O, UDI/DI (EA) 10195327318604, UDI/DI (CS) 40195327318605;  hh) Model Number DYNJ904331I, UDI/DI (EA) 10195327025700, UDI/DI (CS) 40195327025701;  ii) Model Number DYNJ904332J, UDI/DI (EA) 10195327025694, UDI/DI (CS) 40195327025695;  jj) Model Number DYNJ905330B, UDI/DI (EA) 10193489781502, UDI/DI (CS) 40193489781503;  kk) Model Number DYNJ905886G, UDI/DI (EA) 10195327329167, UDI/DI (CS) 40195327329168;  ll) Model Number DYNJ907831D, UDI/DI (EA) 10195327239701, UDI/DI (CS) 40195327239702;  mm) Model Number DYNJ908127B, UDI/DI (EA) 10195327349929, UDI/DI (CS) 40195327349920;  nn) Model Number DYNJ908128B, UDI/DI (EA) 10195327349912, UDI/DI (CS) 40195327349913;  oo) Model Number DYNJ908331A, UDI/DI (EA) 10195327190156, UDI/DI (CS) 40195327190157;  pp) Model Number DYNJ908683A, UDI/DI (EA) 10195327251772, UDI/DI (CS) 40195327251773;  qq) Model Number DYNJ909000, UDI/DI (EA) 10195327238100, UDI/DI (CS) 40195327238101;  rr) Model Number DYNJ909002, UDI/DI (EA) 10195327238148, UDI/DI (CS) 40195327238149;  ss) Model Number DYNJ909198A, UDI/DI (EA) 10195327414788, UDI/DI (CS) 40195327414789;  tt) Model Number DYNJ9428703Q, UDI/DI (EA) 10195327329174, UDI/DI (CS) 40195327329175;  uu) Model Number DYNJ9428745R, UDI/DI (EA) 10195327258368, UDI/DI (CS) 40195327258369;  vv) Model Number DYNJ9428787O, UDI/DI (EA) 10195327328795, UDI/DI (CS) 40195327328795;  All lots within expiry, distributed from Medline between December 2017 - May 2023:",
            "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"
          }
        }
      ]
    }
  ]
}