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  "name": "AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC;   2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB;   3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O;   4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P;   5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F;   6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G;   7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F;   8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K;   9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H;   10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM;   11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D;   12) AV GRAFT RCH  0246952, MODEL/ITEM NUMBER RCAV40C;   13) OPEN HEART PART 1 RCH  0247159, MODEL/ITEM NUMBER RCOH61G;   14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T;   15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM;   16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD;   17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF;   18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH;   19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN;   20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S;   21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q;   22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL;   23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J;   24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E;   25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E;   26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F;   27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G.",
  "description": "FDA recall Z-2464-2025 — American Contract Systems Inc is recalling AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC;   2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB;   3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O;   4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P;   5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F;   6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G;   7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F;   8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K;   9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H;   10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM;   11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D;   12) AV GRAFT RCH  0246952, MODEL/ITEM NUMBER RCAV40C;   13) OPEN HEART PART 1 RCH  0247159, MODEL/ITEM NUMBER RCOH61G;   14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T;   15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM;   16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD;   17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF;   18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH;   19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN;   20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S;   21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q;   22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL;   23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J;   24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E;   25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E;   26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F;   27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G. (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",
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    "name": "AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC;   2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB;   3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O;   4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P;   5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F;   6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G;   7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F;   8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K;   9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H;   10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM;   11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D;   12) AV GRAFT RCH  0246952, MODEL/ITEM NUMBER RCAV40C;   13) OPEN HEART PART 1 RCH  0247159, MODEL/ITEM NUMBER RCOH61G;   14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T;   15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM;   16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD;   17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF;   18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH;   19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN;   20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S;   21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q;   22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL;   23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J;   24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E;   25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E;   26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F;   27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G.",
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      "@type": "schema:Claim",
      "name": "FDA recall Z-2464-2025: American Contract Systems Inc is recalling AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC;   2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB;   3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O;   4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P;   5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F;   6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G;   7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F;   8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K;   9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H;   10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM;   11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D;   12) AV GRAFT RCH  0246952, MODEL/ITEM NUMBER RCAV40C;   13) OPEN HEART PART 1 RCH  0247159, MODEL/ITEM NUMBER RCOH61G;   14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T;   15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM;   16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD;   17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF;   18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH;   19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN;   20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S;   21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q;   22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL;   23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J;   24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E;   25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E;   26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F;   27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G.",
      "text": "The FDA logged enforcement record Z-2464-2025: American Contract Systems Inc is voluntarily recalling AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC;   2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB;   3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O;   4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P;   5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F;   6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G;   7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F;   8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K;   9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H;   10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM;   11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D;   12) AV GRAFT RCH  0246952, MODEL/ITEM NUMBER RCAV40C;   13) OPEN HEART PART 1 RCH  0247159, MODEL/ITEM NUMBER RCOH61G;   14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T;   15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM;   16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD;   17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF;   18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH;   19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN;   20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S;   21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q;   22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL;   23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J;   24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E;   25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E;   26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F;   27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G. — reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-14. Affected lots/codes: 1) MODEL/ITEM NUMBER ANCV78BC:  UDI/DI 00191072235169, Kit Lot Numbers:  42-7844511, 42-8133811, 42-8037211, 42-7952411, 42-7882011;   2) MODEL/ITEM NUMBER ANVA82AB:  UDI/DI 00191072235183, Kit Lot Numbers:  42-8025011, 42-8108511, 42-7928511;  3) MODEL/ITEM NUMBER BHOP48O:  UDI/DI 00191072221490, Kit Lot Numbers:   9207467, 8862838, 9140871, 9049946, 9007346, 8934280;  4) MODEL/ITEM NUMBER BHOP48P:  UDI/DI 00191072234544, Kit Lot Numbers:  9268782, 9345847;  5) MODEL/ITEM NUMBER BHPH18F:  UDI/DI 00191072224651, Kit Lot Numbers:  8993526, 9098058, 8899297;  6) MODEL/ITEM NUMBER BHPH18G:  UDI/DI 00191072234551, Kit Lot Numbers:  9238544;  7) MODEL/ITEM NUMBER HGCB98F:  UDI/DI 00191072205285, Kit Lot Numbers:  42-7813711;  8) MODEL/ITEM NUMBER HGCV05K:  UDI/DI 00191072212474, Kit Lot Numbers:  42-8097611, 42-8021411, 42-7870011, 42-7831911, 42-8093211;  9) MODEL/ITEM NUMBER HGOH99H:  UDI/DI 00191072235336, Kit Lot Numbers:  42-8119511, 42-8044311, 42-7874411;  10) MODEL/ITEM NUMBER MHCV10AM:  UDI/DI 00191072235619. Kit Lot Numbers:  42-7848211;  11) MODEL/ITEM NUMBER MTVS73D:  UDI/DI 00191072237583, Kit Lot Numbers:  12-7397911, 12-7335111, 12-7072111, 12-7142511, 12-7224911;  12) MODEL/ITEM NUMBER RCAV40C:  UDI/DI 00191072235381, Kit Lot Numbers:  42-8053511, 42-8151011, 42-7978811, 42-7853911;  13) MODEL/ITEM NUMBER RCOH61G:  UDI/DI 00191072229823, Kit Lot Numbers:  42-7803611, 42-7941711, 42-7997711, 42-8075711;  14) MODEL/ITEM NUMBER TNCA08T:  UDI/DI 00191072235534, Kit Lot Numbers:  42-7827011, 42-8158811;  15) MODEL/ITEM NUMBER TNCB10AM:  UDI/DI 00191072232991, Kit Lot Numbers:  42-7864811, 42-7971311, 42-8065311;  16) MODEL/ITEM NUMBER UDAV16AD:  UDI/DI 00191072216229, Kit Lot Numbers:  42-7919811;  17) MODEL/ITEM NUMBER UDCP24AF:  UDI/DI 00191072235305, Kit Lot numbers:  42-8010311, 42-8109811;  18) MODEL/ITEM NUMBER UDFP36AH:  UDI/DI 00191072235329, Kit Lot Numbers:  42-7835011, 42-7902811, 42-8014011, 42-8091211;  19) MODEL/ITEM NUMBER UICD62AN:  UDI/DI 00191072200495, Kit Lot Numbers:  42-7874211, 42-7934511, 42-7999011, 42-8072211, 42-8132211;  20) MODEL/ITEM NUMBER UICS88S:  UDI/DI 00191072235428, Kit Lot Numbers:  42-7821511, 42-7913211, 42-7979011, 42-8032611, 42-8106011;  21) MODEL/ITEM NUMBER UIPD03Q:  UDI/DI 00191072235435, Kit Lot Numbers:  42-8083011, 42-8154511;  22) MODEL/ITEM NUMBER UITC53AL:  UDI/DI 00191072235572, Kit Lot Numbers:  42-7887011, 42-7993911, 42-8071411;  23) MODEL/ITEM NUMBER UIVA75J:  UDI/DI 00191072235602, Kit Lot Numbers:  42-7994011, 42-8056011, 42-8114011, 42-7827411, 42-7916411;  24) MODEL/ITEM NUMBER UMCA14E:  UDI/DI 00191072222510, Kit Lot Numbers:  334022, 9238536;  25) MODEL/ITEM NUMBER UMOH42E:  UDI/DI 00191072222534, Kit Lot Numbers:  8860283;  26) MODEL/ITEM NUMBER UMOH42F:  UDI/DI 00191072224712, Kit Lot Numbers:  9125072, 9044687, 8977422, 8925203, 9167965;  27) MODEL/ITEM NUMBER UMOH42G:  UDI/DI  00191072234896, Kit Lot Numbers:  9202772, 9334223.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2464-2025&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-2464-2025&lang=eng"
        }
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      "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-2464-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2464-2025 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-2464-2025&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-2464-2025&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-2464-2025/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."
    }
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      "name": "FDA recall details — Z-2464-2025",
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            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "American Contract Systems Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
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          "item": {
            "Field": "Lot/code info",
            "Value": "1) MODEL/ITEM NUMBER ANCV78BC:  UDI/DI 00191072235169, Kit Lot Numbers:  42-7844511, 42-8133811, 42-8037211, 42-7952411, 42-7882011;   2) MODEL/ITEM NUMBER ANVA82AB:  UDI/DI 00191072235183, Kit Lot Numbers:  42-8025011, 42-8108511, 42-7928511;  3) MODEL/ITEM NUMBER BHOP48O:  UDI/DI 00191072221490, Kit Lot Numbers:   9207467, 8862838, 9140871, 9049946, 9007346, 8934280;  4) MODEL/ITEM NUMBER BHOP48P:  UDI/DI 00191072234544, Kit Lot Numbers:  9268782, 9345847;  5) MODEL/ITEM NUMBER BHPH18F:  UDI/DI 00191072224651, Kit Lot Numbers:  8993526, 9098058, 8899297;  6) MODEL/ITEM NUMBER BHPH18G:  UDI/DI 00191072234551, Kit Lot Numbers:  9238544;  7) MODEL/ITEM NUMBER HGCB98F:  UDI/DI 00191072205285, Kit Lot Numbers:  42-7813711;  8) MODEL/ITEM NUMBER HGCV05K:  UDI/DI 00191072212474, Kit Lot Numbers:  42-8097611, 42-8021411, 42-7870011, 42-7831911, 42-8093211;  9) MODEL/ITEM NUMBER HGOH99H:  UDI/DI 00191072235336, Kit Lot Numbers:  42-8119511, 42-8044311, 42-7874411;  10) MODEL/ITEM NUMBER MHCV10AM:  UDI/DI 00191072235619. Kit Lot Numbers:  42-7848211;  11) MODEL/ITEM NUMBER MTVS73D:  UDI/DI 00191072237583, Kit Lot Numbers:  12-7397911, 12-7335111, 12-7072111, 12-7142511, 12-7224911;  12) MODEL/ITEM NUMBER RCAV40C:  UDI/DI 00191072235381, Kit Lot Numbers:  42-8053511, 42-8151011, 42-7978811, 42-7853911;  13) MODEL/ITEM NUMBER RCOH61G:  UDI/DI 00191072229823, Kit Lot Numbers:  42-7803611, 42-7941711, 42-7997711, 42-8075711;  14) MODEL/ITEM NUMBER TNCA08T:  UDI/DI 00191072235534, Kit Lot Numbers:  42-7827011, 42-8158811;  15) MODEL/ITEM NUMBER TNCB10AM:  UDI/DI 00191072232991, Kit Lot Numbers:  42-7864811, 42-7971311, 42-8065311;  16) MODEL/ITEM NUMBER UDAV16AD:  UDI/DI 00191072216229, Kit Lot Numbers:  42-7919811;  17) MODEL/ITEM NUMBER UDCP24AF:  UDI/DI 00191072235305, Kit Lot numbers:  42-8010311, 42-8109811;  18) MODEL/ITEM NUMBER UDFP36AH:  UDI/DI 00191072235329, Kit Lot Numbers:  42-7835011, 42-7902811, 42-8014011, 42-8091211;  19) MODEL/ITEM NUMBER UICD62AN:  UDI/DI 00191072200495, Kit Lot Numbers:  42-7874211, 42-7934511, 42-7999011, 42-8072211, 42-8132211;  20) MODEL/ITEM NUMBER UICS88S:  UDI/DI 00191072235428, Kit Lot Numbers:  42-7821511, 42-7913211, 42-7979011, 42-8032611, 42-8106011;  21) MODEL/ITEM NUMBER UIPD03Q:  UDI/DI 00191072235435, Kit Lot Numbers:  42-8083011, 42-8154511;  22) MODEL/ITEM NUMBER UITC53AL:  UDI/DI 00191072235572, Kit Lot Numbers:  42-7887011, 42-7993911, 42-8071411;  23) MODEL/ITEM NUMBER UIVA75J:  UDI/DI 00191072235602, Kit Lot Numbers:  42-7994011, 42-8056011, 42-8114011, 42-7827411, 42-7916411;  24) MODEL/ITEM NUMBER UMCA14E:  UDI/DI 00191072222510, Kit Lot Numbers:  334022, 9238536;  25) MODEL/ITEM NUMBER UMOH42E:  UDI/DI 00191072222534, Kit Lot Numbers:  8860283;  26) MODEL/ITEM NUMBER UMOH42F:  UDI/DI 00191072224712, Kit Lot Numbers:  9125072, 9044687, 8977422, 8925203, 9167965;  27) MODEL/ITEM NUMBER UMOH42G:  UDI/DI  00191072234896, Kit Lot Numbers:  9202772, 9334223.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US distribution to states of:  IL and LA",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}