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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1709-2026.jsonld",
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  "name": "Medline kits containing Olympus biopsy valves:    1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G    2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J    3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A    4. RIGID KIT, DYNDA2138A",
  "description": "FDA recall Z-1709-2026 — Medline Industries, LP is recalling Medline kits containing Olympus biopsy valves:    1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G    2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J    3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A    4. RIGID KIT, DYNDA2138A (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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  "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": {
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      "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-1709-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline kits containing Olympus biopsy valves:    1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G    2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J    3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A    4. RIGID KIT, DYNDA2138A",
    "manufacturer": {
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      "name": "Medline Industries, LP"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1709-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1709-2026: Medline Industries, LP is recalling Medline kits containing Olympus biopsy valves:    1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G    2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J    3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A    4. RIGID KIT, DYNDA2138A",
      "text": "The FDA logged enforcement record Z-1709-2026: Medline Industries, LP is voluntarily recalling Medline kits containing Olympus biopsy valves:    1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G    2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J    3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A    4. RIGID KIT, DYNDA2138A — reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-16. Affected lots/codes: 1. DYNJ900898I UDI-DI 10198459273513 (EA) 40198459273514 (CS) LOTS 25DME064 25HMD841 25JMD489 25KME329 25KMH848 25LMC029 25LMH235 25LMK305  DYNJ901922G UDI-DI 10195327640422 (EA) 40195327640423 (CS) LOTS 24KBP812  2. DYKM1417I UDI-DI 10195327456757 (EA) 40195327456758 (CS) LOTS 24DLA405 24ELA912 24GLA871 24ILA151 24JLA326  DYKM1417J UDI-DI 10198459191640 (EA) 40198459191641 (CS) LOTS 25BLA761 25BLA886 25DLA353 25ELA056 25FLA429 25HLA196 25HLA242 25KLA388 25KLA610  3. DYNJ58146A UDI-DI 10193489611977 (EA) 40193489611978 (CS) LOTS 23KDA851 24ADC096 24CDB107 24DDB887 24IDA855 24JDB494 24LDA691 25BMF825 25DMD969 25FMC760 25GMD422  4. DYNDA2138A UDI-DI 10193489874594 (EA) 40193489874595 (CS) 24DBM325 24DBM383 25DBK159. 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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        "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-1709-2026&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-1709-2026&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-1709-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1709-2026 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-1709-2026&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-1709-2026&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-1709-2026/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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        "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."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-1709-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1709-2026",
            "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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            "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": "Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.",
            "Status": "recorded"
          }
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-02-16",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1. DYNJ900898I UDI-DI 10198459273513 (EA) 40198459273514 (CS) LOTS 25DME064 25HMD841 25JMD489 25KME329 25KMH848 25LMC029 25LMH235 25LMK305  DYNJ901922G UDI-DI 10195327640422 (EA) 40195327640423 (CS) LOTS 24KBP812  2. DYKM1417I UDI-DI 10195327456757 (EA) 40195327456758 (CS) LOTS 24DLA405 24ELA912 24GLA871 24ILA151 24JLA326  DYKM1417J UDI-DI 10198459191640 (EA) 40198459191641 (CS) LOTS 25BLA761 25BLA886 25DLA353 25ELA056 25FLA429 25HLA196 25HLA242 25KLA388 25KLA610  3. DYNJ58146A UDI-DI 10193489611977 (EA) 40193489611978 (CS) LOTS 23KDA851 24ADC096 24CDB107 24DDB887 24IDA855 24JDB494 24LDA691 25BMF825 25DMD969 25FMC760 25GMD422  4. DYNDA2138A UDI-DI 10193489874594 (EA) 40193489874595 (CS) 24DBM325 24DBM383 25DBK159",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.",
            "Status": "recorded"
          }
        }
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}