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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0206-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Salem Sump PVC Tubes:    Product Code/Product Name:    8888264911E\tENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN  8888264929E\tENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN  8888264945E\tENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN  8888264960E\tENFit\" Salem Sump\" PVC Tube 16Fr 48IN  8888264986E\tENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN  8888266106E\tPVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN  8888266114E\tPVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN  8888266122E\tPVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN  8888266130E\tPVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN  8888266148E\tPVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN  8888268060E\tENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN  8888268086E\tENFit\" Salem Sump\" PVC Tube 8Fr 24IN",
  "description": "FDA recall Z-0206-2026 — Cardinal Health 200, LLC is recalling Salem Sump PVC Tubes:    Product Code/Product Name:    8888264911E\tENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN  8888264929E\tENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN  8888264945E\tENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN  8888264960E\tENFit\" Salem Sump\" PVC Tube 16Fr 48IN  8888264986E\tENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN  8888266106E\tPVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN  8888266114E\tPVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN  8888266122E\tPVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN  8888266130E\tPVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN  8888266148E\tPVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN  8888268060E\tENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN  8888268086E\tENFit\" Salem Sump\" PVC Tube 8Fr 24IN (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0206-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Salem Sump PVC Tubes:    Product Code/Product Name:    8888264911E\tENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN  8888264929E\tENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN  8888264945E\tENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN  8888264960E\tENFit\" Salem Sump\" PVC Tube 16Fr 48IN  8888264986E\tENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN  8888266106E\tPVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN  8888266114E\tPVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN  8888266122E\tPVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN  8888266130E\tPVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN  8888266148E\tPVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN  8888268060E\tENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN  8888268086E\tENFit\" Salem Sump\" PVC Tube 8Fr 24IN",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cardinal Health 200, LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0206-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0206-2026: Cardinal Health 200, LLC is recalling Salem Sump PVC Tubes:    Product Code/Product Name:    8888264911E\tENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN  8888264929E\tENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN  8888264945E\tENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN  8888264960E\tENFit\" Salem Sump\" PVC Tube 16Fr 48IN  8888264986E\tENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN  8888266106E\tPVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN  8888266114E\tPVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN  8888266122E\tPVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN  8888266130E\tPVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN  8888266148E\tPVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN  8888268060E\tENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN  8888268086E\tENFit\" Salem Sump\" PVC Tube 8Fr 24IN",
      "text": "The FDA logged enforcement record Z-0206-2026: Cardinal Health 200, LLC is voluntarily recalling Salem Sump PVC Tubes:    Product Code/Product Name:    8888264911E\tENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN  8888264929E\tENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN  8888264945E\tENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN  8888264960E\tENFit\" Salem Sump\" PVC Tube 16Fr 48IN  8888264986E\tENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN  8888266106E\tPVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN  8888266114E\tPVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN  8888266122E\tPVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN  8888266130E\tPVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN  8888266148E\tPVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN  8888268060E\tENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN  8888268086E\tENFit\" Salem Sump\" PVC Tube 8Fr 24IN — reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-18. Affected lots/codes: Product Code/Product Name/UDI-DI:  8888264911E ENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN 10884521779419 8888264929E ENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN 10884521779426 8888264945E ENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN 10884521779433 8888264960E ENFit\" Salem Sump\" PVC Tube 16Fr 48IN 10884521779440 8888264986E ENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN 10884521779457 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 10192253012774 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 10192253012798 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 10192253012811 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 10192253012835 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 10192253012859 8888268060E ENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN 10884521779464 8888268086E ENFit\" Salem Sump\" PVC Tube 8Fr 24IN 10884521779471  All Lots. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-0206-2026&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-0206-2026&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-0206-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0206-2026 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
      },
      "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-0206-2026&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-0206-2026&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-0206-2026/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",
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        "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-0206-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0206-2026",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
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        {
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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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Cardinal Health 200, LLC",
            "Status": "recorded"
          }
        },
        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-09-18",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Product Code/Product Name/UDI-DI:  8888264911E ENFit\" SALEM SUMP\" PVC TUBE 10FR 36IN 10884521779419 8888264929E ENFit\" SALEM SUMP\" PVC TUBE 12FR 48IN 10884521779426 8888264945E ENFit\" SALEM SUMP\" PVC TUBE 14FR 48IN 10884521779433 8888264960E ENFit\" Salem Sump\" PVC Tube 16Fr 48IN 10884521779440 8888264986E ENFit\" SALEM SUMP\" PVC TUBE 18FR 48IN 10884521779457 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 10192253012774 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 10192253012798 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 10192253012811 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 10192253012835 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 10192253012859 8888268060E ENFit\" SALEM SUMP\" PVC TUBE 6FR 24IN 10884521779464 8888268086E ENFit\" Salem Sump\" PVC Tube 8Fr 24IN 10884521779471  All Lots",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}