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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0783-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline custom medical procedure kits labeled as:    1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J;   2) MVFF/FIBU #54-RF, REF DYNJ21927R;   3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A;   4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F;   5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F;   6) DIEP FLAP, REF DYNJ66867A;   7) KIT FREE FLAP MOSES, REF DYNJ905366A;   8) FREE FLAP, REF DYNJ905634B;   9) ROBOTIC THORACIC, REF DYNJ907817;   10) TRANSPHENOIDAL, REF DYNJ908165;   11) METREX, REF DYNJ910072;   12) DIEP FLAP, REF DYNJ910120A.",
  "description": "FDA recall Z-0783-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline custom medical procedure kits labeled as:    1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J;   2) MVFF/FIBU #54-RF, REF DYNJ21927R;   3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A;   4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F;   5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F;   6) DIEP FLAP, REF DYNJ66867A;   7) KIT FREE FLAP MOSES, REF DYNJ905366A;   8) FREE FLAP, REF DYNJ905634B;   9) ROBOTIC THORACIC, REF DYNJ907817;   10) TRANSPHENOIDAL, REF DYNJ908165;   11) METREX, REF DYNJ910072;   12) DIEP FLAP, REF DYNJ910120A. (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-0783-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline custom medical procedure kits labeled as:    1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J;   2) MVFF/FIBU #54-RF, REF DYNJ21927R;   3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A;   4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F;   5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F;   6) DIEP FLAP, REF DYNJ66867A;   7) KIT FREE FLAP MOSES, REF DYNJ905366A;   8) FREE FLAP, REF DYNJ905634B;   9) ROBOTIC THORACIC, REF DYNJ907817;   10) TRANSPHENOIDAL, REF DYNJ908165;   11) METREX, REF DYNJ910072;   12) DIEP FLAP, REF DYNJ910120A.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0783-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0783-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline custom medical procedure kits labeled as:    1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J;   2) MVFF/FIBU #54-RF, REF DYNJ21927R;   3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A;   4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F;   5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F;   6) DIEP FLAP, REF DYNJ66867A;   7) KIT FREE FLAP MOSES, REF DYNJ905366A;   8) FREE FLAP, REF DYNJ905634B;   9) ROBOTIC THORACIC, REF DYNJ907817;   10) TRANSPHENOIDAL, REF DYNJ908165;   11) METREX, REF DYNJ910072;   12) DIEP FLAP, REF DYNJ910120A.",
      "text": "The FDA logged enforcement record Z-0783-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline custom medical procedure kits labeled as:    1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J;   2) MVFF/FIBU #54-RF, REF DYNJ21927R;   3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A;   4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F;   5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F;   6) DIEP FLAP, REF DYNJ66867A;   7) KIT FREE FLAP MOSES, REF DYNJ905366A;   8) FREE FLAP, REF DYNJ905634B;   9) ROBOTIC THORACIC, REF DYNJ907817;   10) TRANSPHENOIDAL, REF DYNJ908165;   11) METREX, REF DYNJ910072;   12) DIEP FLAP, REF DYNJ910120A. — reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-21. Affected lots/codes: 1) REF DYNJ0991320J, UDI/DI 10193489686661 (EA) 40193489686662 (CS), Lot Numbers:  19EKB321, 19GKD099, 19JKA065, 19LKB378, 20DKA223, 20EKA239, 20FKB859, 20GKA150, 20HKB438, 21ALA327;   2) REF DYNJ21927R, UDI/DI 10195327104733 (EA) 40195327104734 (CS), Lot Numbers:  23JBK732;   3) REF DYNJ40406A, UDI/DI 10889942215904 (EA) 40889942215905 (CS), Lot Numbers:  23HBD879;   4) REF DYNJ51818F, UDI/DI 10889942741601 (EA) 40889942741602 (CS), Lot Numbers:  19BBA689, 19CBD918;   5) REF DYNJ58648F, UDI/DI 10193489884449 (EA) 40193489884440 (CS), Lot Numbers:  21EMF317;   6) REF DYNJ66867A, UDI/DI 10193489986235 (EA) 40193489986236 (CS), Lot Numbers:  22ABE990, 22FBV019, 22KBK097, 22NBE822, 23DBG870, 23EBR848, 23FBA588, 23HBX771, 23IBW237, 23KBC127, 23KBT141;   7) REF DYNJ905366A, UDI/DI 10193489759372 (EA) 40193489759373 (CS), Lot Numbers:  19LBL885, 20BBJ487, 20CBF683, 20FBC462, 20HBN061, 21CBU514, 21DBO189, 21EBI475, 21EBN240, 21FBT699, 21FBT700, 21FBT702, 21KBN245;   8) REF DYNJ905634B, UDI/DI 10193489633924 (EA) 40193489633925 (CS), Lot Numbers:  19EBD435, 19EBL594, 19FBG295, 19GBR466, 19GBS384, 20FBS328, 21EBM629, 21FBP379, 21FBT340, 22GMH714, 23CMF811, 23DMA128, 23JMD524, 24AMJ344, 24BME042, 24DMB281, 24EMI831, 24FMC477;   9) REF DYNJ907817, UDI/DI 10193489887167 (EA) 40193489887168 (CS), Lot Numbers:  21EBC333;   10) REF DYNJ908165, UDI/DI 10193489992014 (EA) 40193489992015 (CS), Lot Numbers:  22CLA236, 22CLA782, 22FLA058, 22JBI497, 23BBD054, 23BBF440, 23BBG445, 23BBL712, 23FBA102, 23IBO315, 23KBH043, 23KBH076, 23LBG978;   11) REF DYNJ910072, UDI/DI 10195327567538 (EA) 40195327567539 (CS), Lot Numbers:  24CBL710;   12) REF DYNJ910120A, UDI/DI 10195327689872 (EA) 40195327689873 (CS), Lot Numbers:  24HMK254.. 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-0783-2025&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-0783-2025&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-0783-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0783-2025 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-0783-2025&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-0783-2025&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-0783-2025/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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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0783-2025",
      "numberOfItems": 9,
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0783-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "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 - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-11-21",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) REF DYNJ0991320J, UDI/DI 10193489686661 (EA) 40193489686662 (CS), Lot Numbers:  19EKB321, 19GKD099, 19JKA065, 19LKB378, 20DKA223, 20EKA239, 20FKB859, 20GKA150, 20HKB438, 21ALA327;   2) REF DYNJ21927R, UDI/DI 10195327104733 (EA) 40195327104734 (CS), Lot Numbers:  23JBK732;   3) REF DYNJ40406A, UDI/DI 10889942215904 (EA) 40889942215905 (CS), Lot Numbers:  23HBD879;   4) REF DYNJ51818F, UDI/DI 10889942741601 (EA) 40889942741602 (CS), Lot Numbers:  19BBA689, 19CBD918;   5) REF DYNJ58648F, UDI/DI 10193489884449 (EA) 40193489884440 (CS), Lot Numbers:  21EMF317;   6) REF DYNJ66867A, UDI/DI 10193489986235 (EA) 40193489986236 (CS), Lot Numbers:  22ABE990, 22FBV019, 22KBK097, 22NBE822, 23DBG870, 23EBR848, 23FBA588, 23HBX771, 23IBW237, 23KBC127, 23KBT141;   7) REF DYNJ905366A, UDI/DI 10193489759372 (EA) 40193489759373 (CS), Lot Numbers:  19LBL885, 20BBJ487, 20CBF683, 20FBC462, 20HBN061, 21CBU514, 21DBO189, 21EBI475, 21EBN240, 21FBT699, 21FBT700, 21FBT702, 21KBN245;   8) REF DYNJ905634B, UDI/DI 10193489633924 (EA) 40193489633925 (CS), Lot Numbers:  19EBD435, 19EBL594, 19FBG295, 19GBR466, 19GBS384, 20FBS328, 21EBM629, 21FBP379, 21FBT340, 22GMH714, 23CMF811, 23DMA128, 23JMD524, 24AMJ344, 24BME042, 24DMB281, 24EMI831, 24FMC477;   9) REF DYNJ907817, UDI/DI 10193489887167 (EA) 40193489887168 (CS), Lot Numbers:  21EBC333;   10) REF DYNJ908165, UDI/DI 10193489992014 (EA) 40193489992015 (CS), Lot Numbers:  22CLA236, 22CLA782, 22FLA058, 22JBI497, 23BBD054, 23BBF440, 23BBG445, 23BBL712, 23FBA102, 23IBO315, 23KBH043, 23KBH076, 23LBG978;   11) REF DYNJ910072, UDI/DI 10195327567538 (EA) 40195327567539 (CS), Lot Numbers:  24CBL710;   12) REF DYNJ910120A, UDI/DI 10195327689872 (EA) 40195327689873 (CS), Lot Numbers:  24HMK254.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of UAE, and Canada.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}