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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1487-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Bed Assist Bars, labeled as follows:    a) Medline, Model Number BA6800,   b) Medline Martha Stewart, Model Number MDS6800BAMMS",
  "description": "FDA recall Z-1487-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Bed Assist Bars, labeled as follows:    a) Medline, Model Number BA6800,   b) Medline Martha Stewart, Model Number MDS6800BAMMS (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": "Bed Assist Bars, labeled as follows:    a) Medline, Model Number BA6800,   b) Medline Martha Stewart, Model Number MDS6800BAMMS",
    "manufacturer": {
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      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1487-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1487-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Bed Assist Bars, labeled as follows:    a) Medline, Model Number BA6800,   b) Medline Martha Stewart, Model Number MDS6800BAMMS",
      "text": "The FDA logged enforcement record Z-1487-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Bed Assist Bars, labeled as follows:    a) Medline, Model Number BA6800,   b) Medline Martha Stewart, Model Number MDS6800BAMMS — reason: Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, \u001cStandard Specification for Adult Portable Bed Rails and Related Products\u001d and 16 CFR Part 1270, \u001cSafety Standard for Adult Portable Bed Rails\u001d) and failed to meet all mandatory requirements outlined in these standards.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-05. Affected lots/codes: a) Medline, Model Number BA6800, Lot Numbers:  88523090002, 88523090003, 88523100001, 88523100002, 88523100003, 88523110002, 88523110003, 88523120002, 88523120003, 88524010002, 88524020001, 88524020002, 88524030001;  b) Medline Martha Stewart, Model Number MDS6800BAMMS, Lot Numbers:  39323090001, 39323090002, 39323100001, 39323100002, 39323110001, 39323110002, 39323120001, 39323120002, 39324010001, 39324010002;. A RECORDED FDA enforcement action (occurred=true).",
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      "commercialInfluence": false,
      "epistemicStatus": {
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        "supported": true,
        "adjudged": 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-1487-2024&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-1487-2024&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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1487-2024/fda-classification",
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      "name": "FDA classified recall Z-1487-2024 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.",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
      },
      "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-1487-2024/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",
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      "epistemicStatus": {
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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-1487-2024",
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            "Value": "Z-1487-2024",
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            "Value": "Class II",
            "Status": "determination"
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            "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 - Northfield",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, \u001cStandard Specification for Adult Portable Bed Rails and Related Products\u001d and 16 CFR Part 1270, \u001cSafety Standard for Adult Portable Bed Rails\u001d) and failed to meet all mandatory requirements outlined in these standards.",
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            "Field": "Initiated",
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            "Value": "a) Medline, Model Number BA6800, Lot Numbers:  88523090002, 88523090003, 88523100001, 88523100002, 88523100003, 88523110002, 88523110003, 88523120002, 88523120003, 88524010002, 88524020001, 88524020002, 88524030001;  b) Medline Martha Stewart, Model Number MDS6800BAMMS, Lot Numbers:  39323090001, 39323090002, 39323100001, 39323100002, 39323110001, 39323110002, 39323120001, 39323120002, 39324010001, 39324010002;",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the country of Canada.",
            "Status": "recorded"
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