{
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    "claims": {
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      "@container": "@list"
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    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
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    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
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    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2147-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical convenience kits, containing Namic Manifold, Labeled as:    1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508;   2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;   3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N;   4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G;   5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D;   6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F;   7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G;   8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I;   9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C;   10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C;   11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D;   12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F;   13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911;   14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A;   15. CATH PACK, Medline Kit Number/SKU DYNJT6544;   16. LHK, Medline Kit Number/SKU NAM0015;   17. SLU LHK, Medline Kit Number/SKU SAMPC0706.",
  "description": "FDA recall Z-2147-2026 — Medline Industries, LP is recalling Medline medical convenience kits, containing Namic Manifold, Labeled as:    1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508;   2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;   3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N;   4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G;   5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D;   6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F;   7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G;   8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I;   9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C;   10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C;   11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D;   12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F;   13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911;   14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A;   15. CATH PACK, Medline Kit Number/SKU DYNJT6544;   16. LHK, Medline Kit Number/SKU NAM0015;   17. SLU LHK, Medline Kit Number/SKU SAMPC0706. (Devices, Class I). 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",
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  "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-2147-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical convenience kits, containing Namic Manifold, Labeled as:    1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508;   2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;   3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N;   4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G;   5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D;   6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F;   7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G;   8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I;   9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C;   10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C;   11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D;   12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F;   13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911;   14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A;   15. CATH PACK, Medline Kit Number/SKU DYNJT6544;   16. LHK, Medline Kit Number/SKU NAM0015;   17. SLU LHK, Medline Kit Number/SKU SAMPC0706.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2147-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2147-2026: Medline Industries, LP is recalling Medline medical convenience kits, containing Namic Manifold, Labeled as:    1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508;   2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;   3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N;   4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G;   5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D;   6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F;   7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G;   8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I;   9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C;   10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C;   11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D;   12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F;   13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911;   14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A;   15. CATH PACK, Medline Kit Number/SKU DYNJT6544;   16. LHK, Medline Kit Number/SKU NAM0015;   17. SLU LHK, Medline Kit Number/SKU SAMPC0706.",
      "text": "The FDA logged enforcement record Z-2147-2026: Medline Industries, LP is voluntarily recalling Medline medical convenience kits, containing Namic Manifold, Labeled as:    1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508;   2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;   3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N;   4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G;   5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D;   6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F;   7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G;   8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I;   9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C;   10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C;   11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D;   12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F;   13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911;   14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A;   15. CATH PACK, Medline Kit Number/SKU DYNJT6544;   16. LHK, Medline Kit Number/SKU NAM0015;   17. SLU LHK, Medline Kit Number/SKU SAMPC0706. — reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-24. Affected lots/codes: Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25EBB568;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25FBB624;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25GBC747;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25HBF702;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25JBJ140;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26ABB718;  Medline Kit Number/SKU 60010508:  UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26BBI625;  Medline Kit Number/SKU 60160075:  UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23IBC156;  Medline Kit Number/SKU 60160075:  UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23KBB857;  Medline Kit Number/SKU 60160075:  UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24ABL640;  Medline Kit Number/SKU 60160075:  UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24CBD613;  Medline Kit Number/SKU 60160075:  UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24EBQ349;  Medline Kit Number/SKU DYNJ04636N:  UDI/DI each 10198459580918, UDI/DI case 40198459580919, Lot Number: 26AMC406;  Medline Kit Number/SKU DYNJ04636N:  UDI/DI each 10198459580918, UDI/DI case 40198459580919, Lot Number: 26CMA066;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25GBI702;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25GBQ931;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25JBG417;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25KBH544;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26AMC371;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26AMC433;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26CMC609;  Medline Kit Number/SKU DYNJ24250G:  UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26CMC660;  Medline Kit Number/SKU DYNJ38333D:  UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24GMH056;  Medline Kit Number/SKU DYNJ38333D:  UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24HMB740;  Medline Kit Number/SKU DYNJ38333D:  UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24JME459;  Medline Kit Number/SKU DYNJ38333D:  UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24KMJ018;  Medline Kit Number/SKU DYNJ38333D:  UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 25AMG765;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25CME621;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25EMB706;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25EME362;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25HME818;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25KME742;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 26AME732;  Medline Kit Number/SKU DYNJ38333F:  UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 26BME198;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24EMG321;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24GMA788;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24HMA312;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24IMI472;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24KMC197;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25BMC031;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25BMF563;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25CMI786;  Medline Kit Number/SKU DYNJ50779G:  UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25DMH709;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25GMF741;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25HME177;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25IME495;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25KMB250;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25LMC853;  Medline Kit Number/SKU DYNJ50779I:  UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 26CMD408;  Medline Kit Number/SKU DYNJ56140C:  UDI/DI each 10198459477218, UDI/DI case 40198459477219, Lot Number: 25HBV231;  Medline Kit Number/SKU DYNJ56140C:  UDI/DI each 10198459477218, UDI/DI case 40198459477219, Lot Number: 26ABK843;  Medline Kit Number/SKU DYNJ56140C:  UDI/DI each 10198459477218, UDI/DI case 40198459477219, Lot Number: 26CBE251;  Medline Kit Number/SKU DYNJ62310C:  UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24JMG837;  Medline Kit Number/SKU DYNJ62310C:  UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24JMH356;  Medline Kit Number/SKU DYNJ62310C:  UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24KMA339;  Medline Kit Number/SKU DYNJ62310C:  UDI/DI each 10198459104299, UDI/DI case 40198459104290, Lot Number: 24KMC940;  Medline Kit Number/SKU DYNJ62310D:  UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25BMA421;  Medline Kit Number/SKU DYNJ62310D:  UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25BME140;  Medline Kit Number/SKU DYNJ62310D:  UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25CMH080;  Medline Kit Number/SKU DYNJ62310D:  UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25DMB438;  Medline Kit Number/SKU DYNJ62310D:  UDI/DI each 10198459254727, UDI/DI case 40198459254728, Lot Number: 25EMA045;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25GMI604;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25HME419;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25JMF984;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25KMC303;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 25KMJ733;  Medline Kit Number/SKU DYNJ62310F:  UDI/DI each 10198459393327, UDI/DI case 40198459393328, Lot Number: 26BMD977;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23HBE467;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23HBW249;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23HBW251;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23IBC125;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23KBJ681;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23KBT543;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 23LBM984;  Medline Kit Number/SKU DYNJ81911:  UDI/DI each 10195327158699, UDI/DI case 40195327158690, Lot Number: 24BBR688;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24EBP711;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24GBP073;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24IBF171;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24KBH753;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 24LBH071;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25ABM562;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25CBM896;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25FBJ466;  Medline Kit Number/SKU DYNJ81911A:  UDI/DI each 10198459005640, UDI/DI case 40198459005641, Lot Number: 25HBJ125;  Medline Kit Number/SKU DYNJT6544:  UDI/DI each 10198459558689, UDI/DI case 40198459558680, Lot Number: 25KMF858;  Medline Kit Number/SKU DYNJT6544:  UDI/DI each 10198459558689, UDI/DI case 40198459558680, Lot Number: 26BMK015;  Medline Kit Number/SKU NAM0015:  UDI/DI each 10195327374198, UDI/DI case 40195327374199, Lot Number: 23GBQ457;  Medline Kit Number/SKU SAMPC0706:  UDI/DI each 10195327586157, UDI/DI case 40195327586158, Lot Number: 24ADA538.. 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-2147-2026&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-2147-2026&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-2147-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2147-2026 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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-2147-2026&lang=eng",
        "value": "Class I",
        "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-2147-2026&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-2147-2026/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-2147-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2147-2026",
            "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 I",
            "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",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline has identified the presence of particulate within the fluid path of the Manifolds.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-03-24",
            "Status": "recorded"
          }
        },
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          "item": {
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            "Status": "recorded"
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            "Status": "recorded"
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}