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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1710-2026.jsonld",
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  "name": "Medline kits containing Olympus biopsy valves:    1. BRONCH PROCEDURE KIT, DYKE2091    2. BRONCHSCOPY, DYNJ900898G DYNJ901922I      3. BRONCHSCOPY PACK, DYNJ38313B    4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I    5. KIT, WR THORACIC, DYNJ911252    6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B    7. LEX THORACIC, DYNJ902016K DYNJ902016L    8. ORGAN PROCUREMENT, DYNJ908686    9. PULMONARY PACK, DYKE1859    10. THORACIC, DYNJ901666L    11. THORACIC ROBOTICS, DYNJ908777A    12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O    13. XPS, DYNJ907605",
  "description": "FDA recall Z-1710-2026 — Medline Industries, LP is recalling Medline kits containing Olympus biopsy valves:    1. BRONCH PROCEDURE KIT, DYKE2091    2. BRONCHSCOPY, DYNJ900898G DYNJ901922I      3. BRONCHSCOPY PACK, DYNJ38313B    4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I    5. KIT, WR THORACIC, DYNJ911252    6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B    7. LEX THORACIC, DYNJ902016K DYNJ902016L    8. ORGAN PROCUREMENT, DYNJ908686    9. PULMONARY PACK, DYKE1859    10. THORACIC, DYNJ901666L    11. THORACIC ROBOTICS, DYNJ908777A    12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O    13. XPS, DYNJ907605 (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/",
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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-1710-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline kits containing Olympus biopsy valves:    1. BRONCH PROCEDURE KIT, DYKE2091    2. BRONCHSCOPY, DYNJ900898G DYNJ901922I      3. BRONCHSCOPY PACK, DYNJ38313B    4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I    5. KIT, WR THORACIC, DYNJ911252    6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B    7. LEX THORACIC, DYNJ902016K DYNJ902016L    8. ORGAN PROCUREMENT, DYNJ908686    9. PULMONARY PACK, DYKE1859    10. THORACIC, DYNJ901666L    11. THORACIC ROBOTICS, DYNJ908777A    12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O    13. XPS, DYNJ907605",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1710-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1710-2026: Medline Industries, LP is recalling Medline kits containing Olympus biopsy valves:    1. BRONCH PROCEDURE KIT, DYKE2091    2. BRONCHSCOPY, DYNJ900898G DYNJ901922I      3. BRONCHSCOPY PACK, DYNJ38313B    4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I    5. KIT, WR THORACIC, DYNJ911252    6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B    7. LEX THORACIC, DYNJ902016K DYNJ902016L    8. ORGAN PROCUREMENT, DYNJ908686    9. PULMONARY PACK, DYKE1859    10. THORACIC, DYNJ901666L    11. THORACIC ROBOTICS, DYNJ908777A    12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O    13. XPS, DYNJ907605",
      "text": "The FDA logged enforcement record Z-1710-2026: Medline Industries, LP is voluntarily recalling Medline kits containing Olympus biopsy valves:    1. BRONCH PROCEDURE KIT, DYKE2091    2. BRONCHSCOPY, DYNJ900898G DYNJ901922I      3. BRONCHSCOPY PACK, DYNJ38313B    4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I    5. KIT, WR THORACIC, DYNJ911252    6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B    7. LEX THORACIC, DYNJ902016K DYNJ902016L    8. ORGAN PROCUREMENT, DYNJ908686    9. PULMONARY PACK, DYKE1859    10. THORACIC, DYNJ901666L    11. THORACIC ROBOTICS, DYNJ908777A    12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O    13. XPS, DYNJ907605 — 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. DYKE2091 UDI-DI 10198459606397 (EA) 40198459606398 (CS) LOT 25LBR616  2. DYNJ900898G UDI-DI 10195327479473 (EA) 40195327479474 (CS) LOTS 23JBI824 23KBJ535 24ABR789 24ABV917 24BBU610 24DMK530 24FMF039 24GME122 24JMB670 24KMH657 25AMA403 25BME938  DYNJ901922I UDI-DI 10198459237270 (EA) 40198459237271 (CS) LOTS 25BBL628 25FBM655 25HBW072 25KBO230  3. DYNJ38313B UDI-DI 10884389857700 (EA) 40884389857701 (CS) LOTS 24BBR676 24CBF032 24FBD924 24JBE567 25EBA277 25FBO580 25IBI418  4. DYNJ32750G UDI-DI 10889942212491 (EA) 40889942212492 (CS) LOTS 23KME954 23LMD492 24BMF722 24FMH267 24HMC509  DYNJ32750I UDI-DI 10198459245695 (EA) 40198459245696 (CS) LOTS 25BMA765 25DMC474 25EMI991 25IME718 26AMJ190  5. DYNJ911252 UDI-DI 10198459305030 (EA) 40198459305031 (CS) LOTS 25EBU007 25LBC286 25LBI365 26ABC803 26ABU372  6. DYNJ58146B UDI-DI 10198459478253 (EA) 40198459478254 (CS) LOTS 25HMG837 25JMJ636 26AMJ160  7. DYNJ902016K UDI-DI 10195327391706 (EA) 40195327391707 (CS) LOTS 23JBL313 23KBX206 24ABG361 24ABS317 24CBU624 24DBT777 24EBP517 24IBB815 24LBH029 24LBK316 25BBD830 25BBK993 25DBQ241 25DBR926  DYNJ902016L UDI-DI 10198459452703 (EA) 40198459452704 (CS) LOTS 25HBV912 25IBT298 25KBT137  8. DYNJ908686 UDI-DI 10195327145330 (EA) 40195327145331 (CS) LOT 23LBG479  9. DYKE1859 UDI-DI 10195327171469 (EA) 40195327171460 (CS) LOTS 23LBU165 24ABT730 24CBL345 24FBK106 24HBJ512 25DBS024 25EBL346  10. DYNJ901666L UDI-DI 10193489986815 (EA) 40193489986816 (CS) LOTS 24DDC241 24EDB399  11. DYNJ908777A UDI-DI 10195327415174 (EA) 40195327415175 (CS) LOTS 23JBV709 23KBC057 23LBP026 23LBP071 23LBP286 24BBH036 24DBD851 24FBC615 24GBH920 24HBS270 24KBL822 25ABE547 25BBP040 25BBR359 25CBA577  12. DYNJ900482N UDI-DI 10195327509941 (EA) 40195327509942 (CS) LOTS 23KDB600 24ADA178  DYNJ900482O UDI-DI 10195327596569 (EA) 40195327596560 (CS) LOTS 24CDA456 24EDC051 24GDB830 24IDB049 24JDB140 24KDA731 25ADB869 25BDA267 25CMD906  13. DYNJ907605 UDI-DI 10193489468052 (EA) 40193489468053 (CS) LOTS 23JBA743 23JBI519 23LBQ647 24ABX014 24BBQ594. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-1710-2026&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-1710-2026&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-1710-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1710-2026 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-1710-2026&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-1710-2026&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-1710-2026/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,
        "operative": true
      },
      "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-1710-2026",
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            "Field": "Recall number",
            "Value": "Z-1710-2026",
            "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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          "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": "Medline Industries, LP",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-02-16",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1. DYKE2091 UDI-DI 10198459606397 (EA) 40198459606398 (CS) LOT 25LBR616  2. DYNJ900898G UDI-DI 10195327479473 (EA) 40195327479474 (CS) LOTS 23JBI824 23KBJ535 24ABR789 24ABV917 24BBU610 24DMK530 24FMF039 24GME122 24JMB670 24KMH657 25AMA403 25BME938  DYNJ901922I UDI-DI 10198459237270 (EA) 40198459237271 (CS) LOTS 25BBL628 25FBM655 25HBW072 25KBO230  3. DYNJ38313B UDI-DI 10884389857700 (EA) 40884389857701 (CS) LOTS 24BBR676 24CBF032 24FBD924 24JBE567 25EBA277 25FBO580 25IBI418  4. DYNJ32750G UDI-DI 10889942212491 (EA) 40889942212492 (CS) LOTS 23KME954 23LMD492 24BMF722 24FMH267 24HMC509  DYNJ32750I UDI-DI 10198459245695 (EA) 40198459245696 (CS) LOTS 25BMA765 25DMC474 25EMI991 25IME718 26AMJ190  5. DYNJ911252 UDI-DI 10198459305030 (EA) 40198459305031 (CS) LOTS 25EBU007 25LBC286 25LBI365 26ABC803 26ABU372  6. DYNJ58146B UDI-DI 10198459478253 (EA) 40198459478254 (CS) LOTS 25HMG837 25JMJ636 26AMJ160  7. DYNJ902016K UDI-DI 10195327391706 (EA) 40195327391707 (CS) LOTS 23JBL313 23KBX206 24ABG361 24ABS317 24CBU624 24DBT777 24EBP517 24IBB815 24LBH029 24LBK316 25BBD830 25BBK993 25DBQ241 25DBR926  DYNJ902016L UDI-DI 10198459452703 (EA) 40198459452704 (CS) LOTS 25HBV912 25IBT298 25KBT137  8. DYNJ908686 UDI-DI 10195327145330 (EA) 40195327145331 (CS) LOT 23LBG479  9. DYKE1859 UDI-DI 10195327171469 (EA) 40195327171460 (CS) LOTS 23LBU165 24ABT730 24CBL345 24FBK106 24HBJ512 25DBS024 25EBL346  10. DYNJ901666L UDI-DI 10193489986815 (EA) 40193489986816 (CS) LOTS 24DDC241 24EDB399  11. DYNJ908777A UDI-DI 10195327415174 (EA) 40195327415175 (CS) LOTS 23JBV709 23KBC057 23LBP026 23LBP071 23LBP286 24BBH036 24DBD851 24FBC615 24GBH920 24HBS270 24KBL822 25ABE547 25BBP040 25BBR359 25CBA577  12. DYNJ900482N UDI-DI 10195327509941 (EA) 40195327509942 (CS) LOTS 23KDB600 24ADA178  DYNJ900482O UDI-DI 10195327596569 (EA) 40195327596560 (CS) LOTS 24CDA456 24EDC051 24GDB830 24IDB049 24JDB140 24KDA731 25ADB869 25BDA267 25CMD906  13. DYNJ907605 UDI-DI 10193489468052 (EA) 40193489468053 (CS) LOTS 23JBA743 23JBI519 23LBQ647 24ABX014 24BBQ594",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "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"
          }
        }
      ]
    }
  ]
}