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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2170-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tBREAST BIOPSY KIT, Model Number DYNDA1224B;   b)\tU/S CORE BIOPSY KIT, Model Number DYNDH1121C;   c)\tBIOPSY PACK, Model Number DYNDH1124;   d)\tREVAMP BIOPSY TRAY, Model Number DYNDH1147A;   e)\tBREAST BIOPSY TRAY, Model Number DYNDH1266;   f)\tBREAST BIOPSY TRAY, Model Number DYNDH1345A;   g)\tULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A;   h)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   i)\tULTRASOUND BIOPSY, Model Number DYNDH1542B;   j)\tCABARRUS BIOPSY TRAY, Model Number DYNDH1670;   k)\tBREAST BIOPSY TRAY, Model Number DYNDH1677;   l)\tNORTH PARK BIOPSY TRAY, Model Number DYNDH1748;   m)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750;   n)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750A;   o)\tUL BIOPSY TRAY, Model Number DYNDH1778;   p)\tBREAST BIOPSY KIT, Model Number DYNDH1822;   q)\tULTRASOUND BIOPSY, Model Number DYNDH1828;   r)\tBIOPSY PACK-LF, Model Number DYNJ0747885G;   s)\tBIOPSY TRAY, Model Number DYNJ34637G;   t)\tIGT BIOPSY PACK-LF, Model Number DYNJ38616A;   u)\tBIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A;   v)\tCORE BIOPSY PACK-LF, Model Number DYNJ42752A;   w)\tBIOPSY TRAY, Model Number DYNJ43076;   x)\tBIOPSY TRAY, Model Number DYNJ43076A;   y)\tBIOPSY PACK, Model Number DYNJ50485;   z)\tABLATION/DRAINAGE PACK, Model Number DYNJ53658B;   aa)\tBIOPSY RAD CT, Model Number DYNJ59752A;   bb)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992B;   cc)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992C;   dd)\tBIOPSY TRAY, Model Number DYNJ62690;   ee)\tIR BIOPSY PACK, Model Number DYNJ63688A;   ff)\tIR BIOPSY PACK, Model Number DYNJ63688B;   gg)\tIR BIOPSY PACK, Model Number DYNJ63688C;   hh)\tIR BIOPSY PACK, Model Number DYNJ63688G;   ii)\tIR BIOPSY PACK, Model Number DYNJ63688I;   jj)\tINSERTION PACK, Model Number DYNJ83149;   kk)\tGENERAL BIOPSY PACK, Model Number P365500;   ll)\tRENAL BIOPSY TRAY, Model Number SPEC0168;",
  "description": "FDA recall Z-2170-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tBREAST BIOPSY KIT, Model Number DYNDA1224B;   b)\tU/S CORE BIOPSY KIT, Model Number DYNDH1121C;   c)\tBIOPSY PACK, Model Number DYNDH1124;   d)\tREVAMP BIOPSY TRAY, Model Number DYNDH1147A;   e)\tBREAST BIOPSY TRAY, Model Number DYNDH1266;   f)\tBREAST BIOPSY TRAY, Model Number DYNDH1345A;   g)\tULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A;   h)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   i)\tULTRASOUND BIOPSY, Model Number DYNDH1542B;   j)\tCABARRUS BIOPSY TRAY, Model Number DYNDH1670;   k)\tBREAST BIOPSY TRAY, Model Number DYNDH1677;   l)\tNORTH PARK BIOPSY TRAY, Model Number DYNDH1748;   m)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750;   n)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750A;   o)\tUL BIOPSY TRAY, Model Number DYNDH1778;   p)\tBREAST BIOPSY KIT, Model Number DYNDH1822;   q)\tULTRASOUND BIOPSY, Model Number DYNDH1828;   r)\tBIOPSY PACK-LF, Model Number DYNJ0747885G;   s)\tBIOPSY TRAY, Model Number DYNJ34637G;   t)\tIGT BIOPSY PACK-LF, Model Number DYNJ38616A;   u)\tBIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A;   v)\tCORE BIOPSY PACK-LF, Model Number DYNJ42752A;   w)\tBIOPSY TRAY, Model Number DYNJ43076;   x)\tBIOPSY TRAY, Model Number DYNJ43076A;   y)\tBIOPSY PACK, Model Number DYNJ50485;   z)\tABLATION/DRAINAGE PACK, Model Number DYNJ53658B;   aa)\tBIOPSY RAD CT, Model Number DYNJ59752A;   bb)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992B;   cc)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992C;   dd)\tBIOPSY TRAY, Model Number DYNJ62690;   ee)\tIR BIOPSY PACK, Model Number DYNJ63688A;   ff)\tIR BIOPSY PACK, Model Number DYNJ63688B;   gg)\tIR BIOPSY PACK, Model Number DYNJ63688C;   hh)\tIR BIOPSY PACK, Model Number DYNJ63688G;   ii)\tIR BIOPSY PACK, Model Number DYNJ63688I;   jj)\tINSERTION PACK, Model Number DYNJ83149;   kk)\tGENERAL BIOPSY PACK, Model Number P365500;   ll)\tRENAL BIOPSY TRAY, Model Number SPEC0168; (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/",
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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",
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    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2170-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tBREAST BIOPSY KIT, Model Number DYNDA1224B;   b)\tU/S CORE BIOPSY KIT, Model Number DYNDH1121C;   c)\tBIOPSY PACK, Model Number DYNDH1124;   d)\tREVAMP BIOPSY TRAY, Model Number DYNDH1147A;   e)\tBREAST BIOPSY TRAY, Model Number DYNDH1266;   f)\tBREAST BIOPSY TRAY, Model Number DYNDH1345A;   g)\tULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A;   h)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   i)\tULTRASOUND BIOPSY, Model Number DYNDH1542B;   j)\tCABARRUS BIOPSY TRAY, Model Number DYNDH1670;   k)\tBREAST BIOPSY TRAY, Model Number DYNDH1677;   l)\tNORTH PARK BIOPSY TRAY, Model Number DYNDH1748;   m)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750;   n)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750A;   o)\tUL BIOPSY TRAY, Model Number DYNDH1778;   p)\tBREAST BIOPSY KIT, Model Number DYNDH1822;   q)\tULTRASOUND BIOPSY, Model Number DYNDH1828;   r)\tBIOPSY PACK-LF, Model Number DYNJ0747885G;   s)\tBIOPSY TRAY, Model Number DYNJ34637G;   t)\tIGT BIOPSY PACK-LF, Model Number DYNJ38616A;   u)\tBIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A;   v)\tCORE BIOPSY PACK-LF, Model Number DYNJ42752A;   w)\tBIOPSY TRAY, Model Number DYNJ43076;   x)\tBIOPSY TRAY, Model Number DYNJ43076A;   y)\tBIOPSY PACK, Model Number DYNJ50485;   z)\tABLATION/DRAINAGE PACK, Model Number DYNJ53658B;   aa)\tBIOPSY RAD CT, Model Number DYNJ59752A;   bb)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992B;   cc)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992C;   dd)\tBIOPSY TRAY, Model Number DYNJ62690;   ee)\tIR BIOPSY PACK, Model Number DYNJ63688A;   ff)\tIR BIOPSY PACK, Model Number DYNJ63688B;   gg)\tIR BIOPSY PACK, Model Number DYNJ63688C;   hh)\tIR BIOPSY PACK, Model Number DYNJ63688G;   ii)\tIR BIOPSY PACK, Model Number DYNJ63688I;   jj)\tINSERTION PACK, Model Number DYNJ83149;   kk)\tGENERAL BIOPSY PACK, Model Number P365500;   ll)\tRENAL BIOPSY TRAY, Model Number SPEC0168;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2170-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2170-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tBREAST BIOPSY KIT, Model Number DYNDA1224B;   b)\tU/S CORE BIOPSY KIT, Model Number DYNDH1121C;   c)\tBIOPSY PACK, Model Number DYNDH1124;   d)\tREVAMP BIOPSY TRAY, Model Number DYNDH1147A;   e)\tBREAST BIOPSY TRAY, Model Number DYNDH1266;   f)\tBREAST BIOPSY TRAY, Model Number DYNDH1345A;   g)\tULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A;   h)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   i)\tULTRASOUND BIOPSY, Model Number DYNDH1542B;   j)\tCABARRUS BIOPSY TRAY, Model Number DYNDH1670;   k)\tBREAST BIOPSY TRAY, Model Number DYNDH1677;   l)\tNORTH PARK BIOPSY TRAY, Model Number DYNDH1748;   m)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750;   n)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750A;   o)\tUL BIOPSY TRAY, Model Number DYNDH1778;   p)\tBREAST BIOPSY KIT, Model Number DYNDH1822;   q)\tULTRASOUND BIOPSY, Model Number DYNDH1828;   r)\tBIOPSY PACK-LF, Model Number DYNJ0747885G;   s)\tBIOPSY TRAY, Model Number DYNJ34637G;   t)\tIGT BIOPSY PACK-LF, Model Number DYNJ38616A;   u)\tBIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A;   v)\tCORE BIOPSY PACK-LF, Model Number DYNJ42752A;   w)\tBIOPSY TRAY, Model Number DYNJ43076;   x)\tBIOPSY TRAY, Model Number DYNJ43076A;   y)\tBIOPSY PACK, Model Number DYNJ50485;   z)\tABLATION/DRAINAGE PACK, Model Number DYNJ53658B;   aa)\tBIOPSY RAD CT, Model Number DYNJ59752A;   bb)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992B;   cc)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992C;   dd)\tBIOPSY TRAY, Model Number DYNJ62690;   ee)\tIR BIOPSY PACK, Model Number DYNJ63688A;   ff)\tIR BIOPSY PACK, Model Number DYNJ63688B;   gg)\tIR BIOPSY PACK, Model Number DYNJ63688C;   hh)\tIR BIOPSY PACK, Model Number DYNJ63688G;   ii)\tIR BIOPSY PACK, Model Number DYNJ63688I;   jj)\tINSERTION PACK, Model Number DYNJ83149;   kk)\tGENERAL BIOPSY PACK, Model Number P365500;   ll)\tRENAL BIOPSY TRAY, Model Number SPEC0168;",
      "text": "The FDA logged enforcement record Z-2170-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tBREAST BIOPSY KIT, Model Number DYNDA1224B;   b)\tU/S CORE BIOPSY KIT, Model Number DYNDH1121C;   c)\tBIOPSY PACK, Model Number DYNDH1124;   d)\tREVAMP BIOPSY TRAY, Model Number DYNDH1147A;   e)\tBREAST BIOPSY TRAY, Model Number DYNDH1266;   f)\tBREAST BIOPSY TRAY, Model Number DYNDH1345A;   g)\tULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A;   h)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   i)\tULTRASOUND BIOPSY, Model Number DYNDH1542B;   j)\tCABARRUS BIOPSY TRAY, Model Number DYNDH1670;   k)\tBREAST BIOPSY TRAY, Model Number DYNDH1677;   l)\tNORTH PARK BIOPSY TRAY, Model Number DYNDH1748;   m)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750;   n)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750A;   o)\tUL BIOPSY TRAY, Model Number DYNDH1778;   p)\tBREAST BIOPSY KIT, Model Number DYNDH1822;   q)\tULTRASOUND BIOPSY, Model Number DYNDH1828;   r)\tBIOPSY PACK-LF, Model Number DYNJ0747885G;   s)\tBIOPSY TRAY, Model Number DYNJ34637G;   t)\tIGT BIOPSY PACK-LF, Model Number DYNJ38616A;   u)\tBIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A;   v)\tCORE BIOPSY PACK-LF, Model Number DYNJ42752A;   w)\tBIOPSY TRAY, Model Number DYNJ43076;   x)\tBIOPSY TRAY, Model Number DYNJ43076A;   y)\tBIOPSY PACK, Model Number DYNJ50485;   z)\tABLATION/DRAINAGE PACK, Model Number DYNJ53658B;   aa)\tBIOPSY RAD CT, Model Number DYNJ59752A;   bb)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992B;   cc)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992C;   dd)\tBIOPSY TRAY, Model Number DYNJ62690;   ee)\tIR BIOPSY PACK, Model Number DYNJ63688A;   ff)\tIR BIOPSY PACK, Model Number DYNJ63688B;   gg)\tIR BIOPSY PACK, Model Number DYNJ63688C;   hh)\tIR BIOPSY PACK, Model Number DYNJ63688G;   ii)\tIR BIOPSY PACK, Model Number DYNJ63688I;   jj)\tINSERTION PACK, Model Number DYNJ83149;   kk)\tGENERAL BIOPSY PACK, Model Number P365500;   ll)\tRENAL BIOPSY TRAY, Model Number SPEC0168; — 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 DYNDA1224B, UDI/DI (EA) 10193489468519, UDI/DI (CS) 40193489468510;  b) Model Number DYNDH1121C, UDI/DI (EA) 10193489468656, UDI/DI (CS) 40193489468657;  c) Model Number DYNDH1124, UDI/DI (EA) 10889942303274, UDI/DI (CS) 40889942303275;  d) Model Number DYNDH1147A, UDI/DI (EA) 10193489348798, UDI/DI (CS) 40193489348799;  e) Model Number DYNDH1266, UDI/DI (EA) 10889942670451, UDI/DI (CS) 40889942670452;  f) Model Number DYNDH1345A, UDI/DI (EA) 10888277732933, UDI/DI (CS) 40888277732934;  g) Model Number DYNDH1496A, UDI/DI (EA) 10193489825312, UDI/DI (CS) 40193489825313;  h) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 40193489197083;  i) Model Number DYNDH1542B, UDI/DI (EA) 10195327251475, UDI/DI (CS) 40195327251476;  j) Model Number DYNDH1670, UDI/DI (EA) 10195327010683, UDI/DI (CS) 40195327010684;  k) Model Number DYNDH1677, UDI/DI (EA) 10195327044480, UDI/DI (CS) 40195327044481;  l) Model Number DYNDH1748, UDI/DI (EA) 10195327164744, UDI/DI (CS) 40195327164745;  m) Model Number DYNDH1750, UDI/DI (EA) 10195327166427, UDI/DI (CS) 40195327166428;  n) Model Number DYNDH1750A, UDI/DI (EA) 10195327337872, UDI/DI (CS) 40195327337873;  o) Model Number DYNDH1778, UDI/DI (EA) 10195327228477, UDI/DI (CS) 40195327228478;  p) Model Number DYNDH1822, UDI/DI (EA) 10195327292294, UDI/DI (CS) 40195327292295;  q) Model Number DYNDH1828, UDI/DI (EA) 10195327311308, UDI/DI (CS) 40195327311309;  r) Model Number DYNJ0747885G, UDI/DI (EA) 10195327088729, UDI/DI (CS) 40195327088720;  s) Model Number DYNJ34637G, UDI/DI (EA) 10193489368802, UDI/DI (CS) 40193489368803;  t) Model Number DYNJ38616A, UDI/DI (EA) 10884389755952, UDI/DI (CS) 40884389755953;  u) Model Number DYNJ42307A, UDI/DI (EA) 10888277298750, UDI/DI (CS) 40888277298751;  v) Model Number DYNJ42752A, UDI/DI (EA) 10889942326099, UDI/DI (CS) 40889942326090;  w) Model Number DYNJ43076, UDI/DI (EA) 10888277024533, UDI/DI (CS) 40888277024534;  x) Model Number DYNJ43076A, UDI/DI (EA) 10195327080624, UDI/DI (CS) 40195327080625;  y) Model Number DYNJ50485, UDI/DI (EA) 10888277992795, UDI/DI (CS) 40888277992796;  z) Model Number DYNJ53658B, UDI/DI (EA) 10195327088705, UDI/DI (CS) 40195327088706;  aa) Model Number DYNJ59752A, UDI/DI (EA) 10193489598575, UDI/DI (CS) 40193489598576;  bb) Model Number DYNJ61992B, UDI/DI (EA) 10195327292652, UDI/DI (CS) 40195327292653;  cc) Model Number DYNJ61992C, UDI/DI (EA) 10195327406592, UDI/DI (CS) 40195327406593;  dd) Model Number DYNJ62690, UDI/DI (EA) 10193489682267, UDI/DI (CS) 40193489682268;  ee) Model Number DYNJ63688A, UDI/DI (EA) 10193489326451, UDI/DI (CS) 40193489326452;  ff) Model Number DYNJ63688B, UDI/DI (EA) 10193489405590, UDI/DI (CS) 40193489405591;  gg) Model Number DYNJ63688C, UDI/DI (EA) 10193489432282, UDI/DI (CS) 40193489432283;  hh) Model Number DYNJ63688G, UDI/DI (EA) 10193489897197, UDI/DI (CS) 40193489897198;  ii) Model Number DYNJ63688I, UDI/DI (EA) 10195327037239, UDI/DI (CS) 40195327037230;  jj) Model Number DYNJ83149, UDI/DI (EA) 10195327235710, UDI/DI (CS) 40195327235711;  kk) Model Number P365500, UDI/DI (EA) 10889942141852, UDI/DI (CS) 40889942141853;  ll) Model Number SPEC0168, UDI/DI (EA) 10884389869864, UDI/DI (CS) 40884389869865;. 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-2170-2023&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-2170-2023&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-2170-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2170-2023 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-2170-2023&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-2170-2023&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-2170-2023/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-2170-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2170-2023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-18",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "all lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Number DYNDA1224B, UDI/DI (EA) 10193489468519, UDI/DI (CS) 40193489468510;  b) Model Number DYNDH1121C, UDI/DI (EA) 10193489468656, UDI/DI (CS) 40193489468657;  c) Model Number DYNDH1124, UDI/DI (EA) 10889942303274, UDI/DI (CS) 40889942303275;  d) Model Number DYNDH1147A, UDI/DI (EA) 10193489348798, UDI/DI (CS) 40193489348799;  e) Model Number DYNDH1266, UDI/DI (EA) 10889942670451, UDI/DI (CS) 40889942670452;  f) Model Number DYNDH1345A, UDI/DI (EA) 10888277732933, UDI/DI (CS) 40888277732934;  g) Model Number DYNDH1496A, UDI/DI (EA) 10193489825312, UDI/DI (CS) 40193489825313;  h) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 40193489197083;  i) Model Number DYNDH1542B, UDI/DI (EA) 10195327251475, UDI/DI (CS) 40195327251476;  j) Model Number DYNDH1670, UDI/DI (EA) 10195327010683, UDI/DI (CS) 40195327010684;  k) Model Number DYNDH1677, UDI/DI (EA) 10195327044480, UDI/DI (CS) 40195327044481;  l) Model Number DYNDH1748, UDI/DI (EA) 10195327164744, UDI/DI (CS) 40195327164745;  m) Model Number DYNDH1750, UDI/DI (EA) 10195327166427, UDI/DI (CS) 40195327166428;  n) Model Number DYNDH1750A, UDI/DI (EA) 10195327337872, UDI/DI (CS) 40195327337873;  o) Model Number DYNDH1778, UDI/DI (EA) 10195327228477, UDI/DI (CS) 40195327228478;  p) Model Number DYNDH1822, UDI/DI (EA) 10195327292294, UDI/DI (CS) 40195327292295;  q) Model Number DYNDH1828, UDI/DI (EA) 10195327311308, UDI/DI (CS) 40195327311309;  r) Model Number DYNJ0747885G, UDI/DI (EA) 10195327088729, UDI/DI (CS) 40195327088720;  s) Model Number DYNJ34637G, UDI/DI (EA) 10193489368802, UDI/DI (CS) 40193489368803;  t) Model Number DYNJ38616A, UDI/DI (EA) 10884389755952, UDI/DI (CS) 40884389755953;  u) Model Number DYNJ42307A, UDI/DI (EA) 10888277298750, UDI/DI (CS) 40888277298751;  v) Model Number DYNJ42752A, UDI/DI (EA) 10889942326099, UDI/DI (CS) 40889942326090;  w) Model Number DYNJ43076, UDI/DI (EA) 10888277024533, UDI/DI (CS) 40888277024534;  x) Model Number DYNJ43076A, UDI/DI (EA) 10195327080624, UDI/DI (CS) 40195327080625;  y) Model Number DYNJ50485, UDI/DI (EA) 10888277992795, UDI/DI (CS) 40888277992796;  z) Model Number DYNJ53658B, UDI/DI (EA) 10195327088705, UDI/DI (CS) 40195327088706;  aa) Model Number DYNJ59752A, UDI/DI (EA) 10193489598575, UDI/DI (CS) 40193489598576;  bb) Model Number DYNJ61992B, UDI/DI (EA) 10195327292652, UDI/DI (CS) 40195327292653;  cc) Model Number DYNJ61992C, UDI/DI (EA) 10195327406592, UDI/DI (CS) 40195327406593;  dd) Model Number DYNJ62690, UDI/DI (EA) 10193489682267, UDI/DI (CS) 40193489682268;  ee) Model Number DYNJ63688A, UDI/DI (EA) 10193489326451, UDI/DI (CS) 40193489326452;  ff) Model Number DYNJ63688B, UDI/DI (EA) 10193489405590, UDI/DI (CS) 40193489405591;  gg) Model Number DYNJ63688C, UDI/DI (EA) 10193489432282, UDI/DI (CS) 40193489432283;  hh) Model Number DYNJ63688G, UDI/DI (EA) 10193489897197, UDI/DI (CS) 40193489897198;  ii) Model Number DYNJ63688I, UDI/DI (EA) 10195327037239, UDI/DI (CS) 40195327037230;  jj) Model Number DYNJ83149, UDI/DI (EA) 10195327235710, UDI/DI (CS) 40195327235711;  kk) Model Number P365500, UDI/DI (EA) 10889942141852, UDI/DI (CS) 40889942141853;  ll) Model Number SPEC0168, UDI/DI (EA) 10884389869864, UDI/DI (CS) 40884389869865;",
            "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"
          }
        }
      ]
    }
  ]
}