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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2226-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Silastic Foley Catheters  Silastic Brand Foley Catheter 30cc  REF:  33416  33418  33420  33422  33424    Silastic Brand Foley Catheter 5cc  REF:  33614  33616  33618  33620  33622  33624",
  "description": "FDA recall Z-2226-2026 — C.R. Bard Inc is recalling Silastic Foley Catheters  Silastic Brand Foley Catheter 30cc  REF:  33416  33418  33420  33422  33424    Silastic Brand Foley Catheter 5cc  REF:  33614  33616  33618  33620  33622  33624 (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/",
  "isAccessibleForFree": true,
  "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-2226-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Silastic Foley Catheters  Silastic Brand Foley Catheter 30cc  REF:  33416  33418  33420  33422  33424    Silastic Brand Foley Catheter 5cc  REF:  33614  33616  33618  33620  33622  33624",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "C.R. Bard Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2226-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2226-2026: C.R. Bard Inc is recalling Silastic Foley Catheters  Silastic Brand Foley Catheter 30cc  REF:  33416  33418  33420  33422  33424    Silastic Brand Foley Catheter 5cc  REF:  33614  33616  33618  33620  33622  33624",
      "text": "The FDA logged enforcement record Z-2226-2026: C.R. Bard Inc is voluntarily recalling Silastic Foley Catheters  Silastic Brand Foley Catheter 30cc  REF:  33416  33418  33420  33422  33424    Silastic Brand Foley Catheter 5cc  REF:  33614  33616  33618  33620  33622  33624 — reason: Due to stain present on the surface of affected foley catheters.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-04-23. Affected lots/codes: Silastic Brand Foley Catheter 30cc Catalog Number / UDI code: 33416 / 00801741019982 10801741019989 Lot Number: NGKX0444  33418 / 00801741019999 10801741019996 Lot Number: NGKW2813  33420 / 00801741020001 10801741020008 Lot Number: NGKQ1015  33422 / 00801741020018 10801741020015 Lot Number: NGKW3707  33424 / 00801741020025 10801741020022 Lot Number: NGKW2669   Silastic Brand Foley Catheter 5cc Catalog Number / UDI code: 33614 / 00801741020056 10801741020053 Lot Numbers: NGKN4037 NGKP1420 NGKQ0040 NGKQ3901 NGKS4937 NGKV3462 NGKW3897  33616 / 00801741020063 10801741020060 Lot Numbers: NGKQ0042 NGKQ3946 NGKR3420 NGKT3281 NGKU1015 NGKV0617 NGKV2275 NGKV2309 NGKW3771  33618 / 00801741020070 10801741020077 Lot Numbers: NGKQ3370 NGKS3753 NGKT3258 NGKT3309 NGKU4129 NGKV1446 NGKV2345 NGKV3478 NGKV5029  33620 / 00801741020087 10801741020084 Lot Numbers: NGKS5060 NGKT3308 NGKV3689  33622 / 00801741020094 10801741020091 Lot Numbers: NGKQ1016 NGKS0244 NGKU0967 NGKV5075 NGKX0441  33624 / 00801741020100 10801741020107 Lot Numbers: NGKQ1722 NGKQ3862 NGKT3259 NGKX0456. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "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-2226-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-2226-2026&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-2226-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2226-2026 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-2226-2026&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-2226-2026&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-2226-2026/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": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
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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-2226-2026",
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            "Value": "Z-2226-2026",
            "Status": "recorded"
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          "position": 2,
          "item": {
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            "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": "C.R. Bard Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to stain present on the surface of affected foley catheters.",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-04-23",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Silastic Brand Foley Catheter 30cc Catalog Number / UDI code: 33416 / 00801741019982 10801741019989 Lot Number: NGKX0444  33418 / 00801741019999 10801741019996 Lot Number: NGKW2813  33420 / 00801741020001 10801741020008 Lot Number: NGKQ1015  33422 / 00801741020018 10801741020015 Lot Number: NGKW3707  33424 / 00801741020025 10801741020022 Lot Number: NGKW2669   Silastic Brand Foley Catheter 5cc Catalog Number / UDI code: 33614 / 00801741020056 10801741020053 Lot Numbers: NGKN4037 NGKP1420 NGKQ0040 NGKQ3901 NGKS4937 NGKV3462 NGKW3897  33616 / 00801741020063 10801741020060 Lot Numbers: NGKQ0042 NGKQ3946 NGKR3420 NGKT3281 NGKU1015 NGKV0617 NGKV2275 NGKV2309 NGKW3771  33618 / 00801741020070 10801741020077 Lot Numbers: NGKQ3370 NGKS3753 NGKT3258 NGKT3309 NGKU4129 NGKV1446 NGKV2345 NGKV3478 NGKV5029  33620 / 00801741020087 10801741020084 Lot Numbers: NGKS5060 NGKT3308 NGKV3689  33622 / 00801741020094 10801741020091 Lot Numbers: NGKQ1016 NGKS0244 NGKU0967 NGKV5075 NGKX0441  33624 / 00801741020100 10801741020107 Lot Numbers: NGKQ1722 NGKQ3862 NGKT3259 NGKX0456",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S.: AK, AR, AZ, CA, CO, CT, FL, GA,  HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI  O.U.S.: Canada",
            "Status": "recorded"
          }
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}