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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1050-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O;   2) OPEN HEART CDSKit SKU CDS984355K;   3) BAG A OPEN HEART KITKit SKU DYKM1025D;   4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O;   5) OPEN HEART CDSKit SKU DYNJ902879T;   6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F;   7) OPEN HEART CDSKit SKU DYNJ905557B;   8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.",
  "description": "FDA recall Z-1050-2026 — Medline Industries, LP is recalling Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O;   2) OPEN HEART CDSKit SKU CDS984355K;   3) BAG A OPEN HEART KITKit SKU DYKM1025D;   4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O;   5) OPEN HEART CDSKit SKU DYNJ902879T;   6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F;   7) OPEN HEART CDSKit SKU DYNJ905557B;   8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D. (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": "openFDA drug & device enforcement (recall) reports",
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    "@type": "schema:MedicalDevice",
    "name": "Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O;   2) OPEN HEART CDSKit SKU CDS984355K;   3) BAG A OPEN HEART KITKit SKU DYKM1025D;   4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O;   5) OPEN HEART CDSKit SKU DYNJ902879T;   6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F;   7) OPEN HEART CDSKit SKU DYNJ905557B;   8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1050-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1050-2026: Medline Industries, LP is recalling Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O;   2) OPEN HEART CDSKit SKU CDS984355K;   3) BAG A OPEN HEART KITKit SKU DYKM1025D;   4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O;   5) OPEN HEART CDSKit SKU DYNJ902879T;   6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F;   7) OPEN HEART CDSKit SKU DYNJ905557B;   8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.",
      "text": "The FDA logged enforcement record Z-1050-2026: Medline Industries, LP is voluntarily recalling Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O;   2) OPEN HEART CDSKit SKU CDS984355K;   3) BAG A OPEN HEART KITKit SKU DYKM1025D;   4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O;   5) OPEN HEART CDSKit SKU DYNJ902879T;   6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F;   7) OPEN HEART CDSKit SKU DYNJ905557B;   8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D. — reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-11-26. Affected lots/codes: Medline SKU PHS972096014B, UDI/DI 10889942695911 (EA) 40889942695912 (CS), Lot Number 25GBY100;  Medline SKU CDS984289O, UDI/DI 10198459418143 (EA) 40198459418144 (CS), Lot Number 25HBI736;  Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBL296;  Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBN030;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25HLA445;  Medline SKU DYKM1025D, UDI/DI 10195327482893 (EA) 40195327482894 (CS), Lot Number 25HMA140;  Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IBI197;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IBL774;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IMG620;  Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IMH657;  Medline SKU PHS972012D, UDI/DI 10193489571875 (EA) 40193489571876 (CS), Lot Number 25IMH924;  Medline SKU DYNJ905557B, UDI/DI 10193489468243 (EA) 40193489468244 (CS), Lot Number 25JBH529;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25JBO555;  Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25JLA937;  Medline SKU CDS984355K, UDI/DI 10198459258848 (EA) 40198459258849 (CS), Lot Number 25KBB119;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
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        "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-1050-2026&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-1050-2026&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-1050-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1050-2026 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
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      "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-1050-2026&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-1050-2026&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-1050-2026/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": {
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        "supported": true,
        "adjudged": false,
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      "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-1050-2026",
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            "Value": "Z-1050-2026",
            "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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          "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": "Medline Industries, LP",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.",
            "Status": "recorded"
          }
        },
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          "item": {
            "Field": "Initiated",
            "Value": "2025-11-26",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Medline SKU PHS972096014B, UDI/DI 10889942695911 (EA) 40889942695912 (CS), Lot Number 25GBY100;  Medline SKU CDS984289O, UDI/DI 10198459418143 (EA) 40198459418144 (CS), Lot Number 25HBI736;  Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBL296;  Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBN030;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25HLA445;  Medline SKU DYKM1025D, UDI/DI 10195327482893 (EA) 40195327482894 (CS), Lot Number 25HMA140;  Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IBI197;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IBL774;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IMG620;  Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IMH657;  Medline SKU PHS972012D, UDI/DI 10193489571875 (EA) 40193489571876 (CS), Lot Number 25IMH924;  Medline SKU DYNJ905557B, UDI/DI 10193489468243 (EA) 40193489468244 (CS), Lot Number 25JBH529;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25JBO555;  Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25JLA937;  Medline SKU CDS984355K, UDI/DI 10198459258848 (EA) 40198459258849 (CS), Lot Number 25KBB119;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512;  Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512.",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
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}