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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0917-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Cardinal Health Presource Kits:  1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ;  2) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH1;  3) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH2;  4) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH3;  5) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH4;  6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5;  7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6;  8) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHA;  9) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHB;  10) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHC;  11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD;  12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE;  13) ENT PACK     , Catalog Number: SEN55ENSH2;  14) ENT PACK     , Catalog Number: SEN55ENSHA;  15) ENT PACK     , Catalog Number: SEN55ENSHB;  16) EYE PACK     , Catalog Number: SEY51EYKIK;  17) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH1;  18) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH2;  19) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHHB;  20) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHHC;;",
  "description": "FDA recall Z-0917-2025 — Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits:  1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ;  2) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH1;  3) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH2;  4) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH3;  5) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH4;  6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5;  7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6;  8) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHA;  9) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHB;  10) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHC;  11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD;  12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE;  13) ENT PACK     , Catalog Number: SEN55ENSH2;  14) ENT PACK     , Catalog Number: SEN55ENSHA;  15) ENT PACK     , Catalog Number: SEN55ENSHB;  16) EYE PACK     , Catalog Number: SEY51EYKIK;  17) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH1;  18) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH2;  19) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHHB;  20) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHHC;; (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0917-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Cardinal Health Presource Kits:  1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ;  2) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH1;  3) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH2;  4) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH3;  5) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH4;  6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5;  7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6;  8) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHA;  9) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHB;  10) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHC;  11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD;  12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE;  13) ENT PACK     , Catalog Number: SEN55ENSH2;  14) ENT PACK     , Catalog Number: SEN55ENSHA;  15) ENT PACK     , Catalog Number: SEN55ENSHB;  16) EYE PACK     , Catalog Number: SEY51EYKIK;  17) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH1;  18) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH2;  19) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHHB;  20) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHHC;;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cardinal Health 200, LLC"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0917-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0917-2025: Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits:  1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ;  2) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH1;  3) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH2;  4) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH3;  5) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH4;  6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5;  7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6;  8) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHA;  9) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHB;  10) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHC;  11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD;  12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE;  13) ENT PACK     , Catalog Number: SEN55ENSH2;  14) ENT PACK     , Catalog Number: SEN55ENSHA;  15) ENT PACK     , Catalog Number: SEN55ENSHB;  16) EYE PACK     , Catalog Number: SEY51EYKIK;  17) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH1;  18) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH2;  19) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHHB;  20) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHHC;;",
      "text": "The FDA logged enforcement record Z-0917-2025: Cardinal Health 200, LLC is voluntarily recalling Cardinal Health Presource Kits:  1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ;  2) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH1;  3) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH2;  4) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH3;  5) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH4;  6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5;  7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6;  8) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHA;  9) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHB;  10) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHC;  11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD;  12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE;  13) ENT PACK     , Catalog Number: SEN55ENSH2;  14) ENT PACK     , Catalog Number: SEN55ENSHA;  15) ENT PACK     , Catalog Number: SEN55ENSHB;  16) EYE PACK     , Catalog Number: SEY51EYKIK;  17) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH1;  18) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH2;  19) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHHB;  20) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHHC;; — reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-08. Affected lots/codes: Catalog Number PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS), Lot Number  J43U76         ;  Catalog Number PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS), Lot Number  J43U77         ;  Catalog Number PWHFHNAMH1, UDI/DI 10888439744729 (EA)50888439744727 (CS), Lot Number  J34J42         ;  Catalog Number PWHFHNAMH2, UDI/DI 10195594014018 (EA)50195594014016 (CS), Lot Number  J8124C         ;  Catalog Number PWHFHNAMH3, UDI/DI 10195594343477 (EA)50195594343475 (CS), Lot Number  5478802        ;  Catalog Number PWHFHNAMH4, UDI/DI 10197106340523 (EA)50197106340521 (CS), Lot Number  6702010        ;  Catalog Number PWHFHNAMH5, UDI/DI 10197106497425 (EA)50197106497423 (CS), Lot Number  6928766        ;  Catalog Number PWHFHNAMH6, UDI/DI 10197106566107 (EA)50197106566105 (CS), Lot Number  7280108        ;  Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number  J53W73         ;  Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number  J5679J         ;  Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number  J5679D         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J6050D         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J5679K         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J5679K         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J74A31         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  6596396        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J8671P         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J6050H         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5135997        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5533333        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J70X17         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5664099        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5140345        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5664103        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5891308        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5891307        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J6367H         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  6025791        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  L00302         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  6560945        ;  Catalog Number PWHFHNAMHD, UDI/DI 10197106344972 (EA)50197106344970 (CS), Lot Number  6702009        ;  Catalog Number PWHFHNAMHE, UDI/DI 10197106644010 (EA)50197106644018 (CS), Lot Number  6928770        ;  Catalog Number SEN55ENSH2, UDI/DI 10197106366837 (EA)50197106366835 (CS), Lot Number  6914944        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6022130        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6702009        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6806115        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6806114        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  6928759        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  6928766        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7280107        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  5              ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7280109        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7331341        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7332916        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  6928772        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7332907        ;  Catalog Number SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS), Lot Number  7332905        ;  Catalog Number SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS), Lot Number  6928770        ;  Catalog Number SEYOCPEHH1, UDI/DI 10888439980271 (EA)50888439980279 (CS), Lot Number  J8692Y         ;  Catalog Number SEYOCPEHH2, UDI/DI 10197106337004 (EA)50197106337002 (CS), Lot Number  6702010        ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J37U06         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J31U58         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J46C00         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J4952D         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J5679A         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J53W68         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  N/A            ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J5679K         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J84K02         ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  2300125464     ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6563992        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6702010        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928758        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928759        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928764        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7163103        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7280105        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7332904        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928770        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7332918        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  J86T81         ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5135984        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5140348        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5405626        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5533334        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5664098        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5747232        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5891307        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5891305        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5891313        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6022133        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6022130        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6264567        ;. 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-0917-2025&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-0917-2025&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-0917-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0917-2025 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-0917-2025&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-0917-2025&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-0917-2025/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-0917-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0917-2025",
            "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": "Cardinal Health 200, LLC",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-11-08",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Catalog Number PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS), Lot Number  J43U76         ;  Catalog Number PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS), Lot Number  J43U77         ;  Catalog Number PWHFHNAMH1, UDI/DI 10888439744729 (EA)50888439744727 (CS), Lot Number  J34J42         ;  Catalog Number PWHFHNAMH2, UDI/DI 10195594014018 (EA)50195594014016 (CS), Lot Number  J8124C         ;  Catalog Number PWHFHNAMH3, UDI/DI 10195594343477 (EA)50195594343475 (CS), Lot Number  5478802        ;  Catalog Number PWHFHNAMH4, UDI/DI 10197106340523 (EA)50197106340521 (CS), Lot Number  6702010        ;  Catalog Number PWHFHNAMH5, UDI/DI 10197106497425 (EA)50197106497423 (CS), Lot Number  6928766        ;  Catalog Number PWHFHNAMH6, UDI/DI 10197106566107 (EA)50197106566105 (CS), Lot Number  7280108        ;  Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number  J53W73         ;  Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number  J5679J         ;  Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number  J5679D         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J6050D         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J5679K         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J5679K         ;  Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number  J74A31         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  6596396        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J8671P         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J6050H         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5135997        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5533333        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J70X17         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5664099        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5140345        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5664103        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5891308        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  5891307        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  J6367H         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  6025791        ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  L00302         ;  Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number  6560945        ;  Catalog Number PWHFHNAMHD, UDI/DI 10197106344972 (EA)50197106344970 (CS), Lot Number  6702009        ;  Catalog Number PWHFHNAMHE, UDI/DI 10197106644010 (EA)50197106644018 (CS), Lot Number  6928770        ;  Catalog Number SEN55ENSH2, UDI/DI 10197106366837 (EA)50197106366835 (CS), Lot Number  6914944        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6022130        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6702009        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6806115        ;  Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number  6806114        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  6928759        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  6928766        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7280107        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  5              ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7280109        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7331341        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7332916        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  6928772        ;  Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number  7332907        ;  Catalog Number SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS), Lot Number  7332905        ;  Catalog Number SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS), Lot Number  6928770        ;  Catalog Number SEYOCPEHH1, UDI/DI 10888439980271 (EA)50888439980279 (CS), Lot Number  J8692Y         ;  Catalog Number SEYOCPEHH2, UDI/DI 10197106337004 (EA)50197106337002 (CS), Lot Number  6702010        ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J37U06         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J31U58         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J46C00         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J4952D         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J5679A         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J53W68         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  N/A            ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J5679K         ;  Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number  J84K02         ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  2300125464     ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6563992        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6702010        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928758        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928759        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928764        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7163103        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7280105        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7332904        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6928770        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  7332918        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  J86T81         ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5135984        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5140348        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5405626        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5533334        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5664098        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5747232        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5891307        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5891305        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  5891313        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6022133        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6022130        ;  Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number  6264567        ;",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}