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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0786-2025.jsonld",
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  "name": "Medline custom medical procedure kits labeled as:    1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R;  2) FREE FLAP PACK-LF, REF DYNJ42833A;  3) FREE FLAP PACK-LF, REF DYNJ42833B;  4) TYMPANOPLASTY PACK, REF DYNJ50692C;  5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B;  6) FREE FLAP CUSTOM PACK A, REF DYNJ82735;  7) NSR-SMR, REF DYNJ903144C;  8) KIT FACIAL MINORPLASTICS MOSES, REF DYNJ905365A;  9) SEPTOPLASTY, REF DYNJ906474;  10) SEPTOPLASTY, REF DYNJ906474A;  11) FREE FLAP, REF DYNJ907802;  12) MINOR DIEP, REF DYNJ907863;  13) MAIN FLAP, REF DYNJ908264.",
  "description": "FDA recall Z-0786-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline custom medical procedure kits labeled as:    1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R;  2) FREE FLAP PACK-LF, REF DYNJ42833A;  3) FREE FLAP PACK-LF, REF DYNJ42833B;  4) TYMPANOPLASTY PACK, REF DYNJ50692C;  5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B;  6) FREE FLAP CUSTOM PACK A, REF DYNJ82735;  7) NSR-SMR, REF DYNJ903144C;  8) KIT FACIAL MINORPLASTICS MOSES, REF DYNJ905365A;  9) SEPTOPLASTY, REF DYNJ906474;  10) SEPTOPLASTY, REF DYNJ906474A;  11) FREE FLAP, REF DYNJ907802;  12) MINOR DIEP, REF DYNJ907863;  13) MAIN FLAP, REF DYNJ908264. (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",
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      "@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-0786-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline custom medical procedure kits labeled as:    1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R;  2) FREE FLAP PACK-LF, REF DYNJ42833A;  3) FREE FLAP PACK-LF, REF DYNJ42833B;  4) TYMPANOPLASTY PACK, REF DYNJ50692C;  5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B;  6) FREE FLAP CUSTOM PACK A, REF DYNJ82735;  7) NSR-SMR, REF DYNJ903144C;  8) KIT FACIAL MINORPLASTICS MOSES, REF DYNJ905365A;  9) SEPTOPLASTY, REF DYNJ906474;  10) SEPTOPLASTY, REF DYNJ906474A;  11) FREE FLAP, REF DYNJ907802;  12) MINOR DIEP, REF DYNJ907863;  13) MAIN FLAP, REF DYNJ908264.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0786-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0786-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline custom medical procedure kits labeled as:    1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R;  2) FREE FLAP PACK-LF, REF DYNJ42833A;  3) FREE FLAP PACK-LF, REF DYNJ42833B;  4) TYMPANOPLASTY PACK, REF DYNJ50692C;  5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B;  6) FREE FLAP CUSTOM PACK A, REF DYNJ82735;  7) NSR-SMR, REF DYNJ903144C;  8) KIT FACIAL MINORPLASTICS MOSES, REF DYNJ905365A;  9) SEPTOPLASTY, REF DYNJ906474;  10) SEPTOPLASTY, REF DYNJ906474A;  11) FREE FLAP, REF DYNJ907802;  12) MINOR DIEP, REF DYNJ907863;  13) MAIN FLAP, REF DYNJ908264.",
      "text": "The FDA logged enforcement record Z-0786-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline custom medical procedure kits labeled as:    1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R;  2) FREE FLAP PACK-LF, REF DYNJ42833A;  3) FREE FLAP PACK-LF, REF DYNJ42833B;  4) TYMPANOPLASTY PACK, REF DYNJ50692C;  5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B;  6) FREE FLAP CUSTOM PACK A, REF DYNJ82735;  7) NSR-SMR, REF DYNJ903144C;  8) KIT FACIAL MINORPLASTICS MOSES, REF DYNJ905365A;  9) SEPTOPLASTY, REF DYNJ906474;  10) SEPTOPLASTY, REF DYNJ906474A;  11) FREE FLAP, REF DYNJ907802;  12) MINOR DIEP, REF DYNJ907863;  13) MAIN FLAP, REF DYNJ908264. — 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 DYNJ0660040R, UDI/DI 10889942220083 (EA) 40889942220084 (CS), Lot Numbers:  19BKB772, 19DKB804, 19FKB661, 19GKD118, 19IKA148, 19KKB086, 20AKB057, 20BKB114, 20FKB215, 20JKA546, 20LMA968, 20LMF795, 21DMA309, 21DMF310, 21FMA264, 21GMB043, 21HMD757, 21JMC608, 21KMH631, 22CMB438;   2) REF DYNJ42833A, UDI/DI 10888277503991 (EA) 40888277503992 (CS), Lot Numbers:  19ABS779, 19EBZ888, 19FBJ253, 19FBO513, 19FBX305, 19GBF427, 19LBY431, 20CBD972, 20DBV565, 20HBL275, 20LBA473, 20LBG895, 21CBI208;   3) REF DYNJ42833B, UDI/DI 10193489880335 (EA) 40193489880336 (CS), Lot Numbers:  21GBJ447, 21GBJ449, 21HBM834, 21HBR207, 22CBT921, 22DBM124, 22GBD852, 22HBF050, 22HBJ420, 22IBJ529, 22KBR876, 23BBA545, 23CBD715, 23CBQ582, 23DBH453, 23HBE012, 23HBR165, 23IBK906, 23KBP817, 24BBA648, 24DBD590, 24FBI859, 24GBU033, 24IBG868, 24JBI576;   4) REF DYNJ50692C, UDI/DI 10193489752199 (EA) 40193489752190 (CS), Lot Numbers:  19KDA566, 20BDC412, 20CDA575, 20GMD317, 21DMA002;   5) REF DYNJ54736B, UDI/DI 10889942925483 (EA) 40889942925484 (CS), Lot Numbers:  19ABB603, 19ABV222, 19CBN379, 19DBS122, 19EBZ894, 19FBQ049;   6) REF DYNJ82735, UDI/DI 10195327207540 (EA) 40195327207541 (CS), Lot Numbers:  22KMF252, 23EMG596, 23FMA429, 23IMA461, 23JMC236, 24BMC071;   7) REF DYNJ903144C, UDI/DI 10193489677881 (EA) 40193489677882 (CS), Lot Numbers:  19JBK003, 19SBD201, 20ABZ780, 20FBK295, 20GBR819, 20IBH005, 20LBK729, 20LBL461, 20LBO417, 20LBU129, 22AMA090, 22AMC790, 22BMF138, 22EMH876;   8) REF DYNJ905365A, UDI/DI 10193489759037 (EA) 40193489759038 (CS), Lot Numbers:  19IBR377, 20CBO773, 20GBI734, 20GBJ843, 20HBC012, 20IBQ906, 20JBO730, 21CBZ725, 21DBU031, 21GBF999, 21IBC232, 21VBB589;   9) REF DYNJ906474, UDI/DI 10193489750492 (EA) 40193489750493 (CS), Lot Numbers:  20ADB316, 20BDC489;   10) REF DYNJ906474A, UDI/DI 10193489344721 (EA) 40193489344722 (CS), Lot Numbers: 20EDC407, 20FDB425, 20HDA265, 20KDA931, 20KDC466, 21BDA054, 21EDA134, 21FDB465, 21GDB063, 21HDB526, 21IDA248;    11) REF DYNJ907802, UDI/DI 10193489890006 (EA) 40193489890007 (CS), Lot Numbers:  21GBI826, 22IBH914;   12) REF DYNJ907863, UDI/DI 10193489913187 (EA) 40193489913188 (CS), Lot Numbers:  21GBJ056, 21JBZ373, 21KBX700, 21LBV116;   13) REF DYNJ908264, UDI/DI 10195327020118 (EA) 40195327020119 (CS), Lot Numbers:  21LBU103.. 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-0786-2025&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-0786-2025&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-0786-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0786-2025 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-0786-2025&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-0786-2025&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-0786-2025/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-0786-2025",
      "numberOfItems": 9,
      "itemListElement": [
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0786-2025",
            "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 DYNJ0660040R, UDI/DI 10889942220083 (EA) 40889942220084 (CS), Lot Numbers:  19BKB772, 19DKB804, 19FKB661, 19GKD118, 19IKA148, 19KKB086, 20AKB057, 20BKB114, 20FKB215, 20JKA546, 20LMA968, 20LMF795, 21DMA309, 21DMF310, 21FMA264, 21GMB043, 21HMD757, 21JMC608, 21KMH631, 22CMB438;   2) REF DYNJ42833A, UDI/DI 10888277503991 (EA) 40888277503992 (CS), Lot Numbers:  19ABS779, 19EBZ888, 19FBJ253, 19FBO513, 19FBX305, 19GBF427, 19LBY431, 20CBD972, 20DBV565, 20HBL275, 20LBA473, 20LBG895, 21CBI208;   3) REF DYNJ42833B, UDI/DI 10193489880335 (EA) 40193489880336 (CS), Lot Numbers:  21GBJ447, 21GBJ449, 21HBM834, 21HBR207, 22CBT921, 22DBM124, 22GBD852, 22HBF050, 22HBJ420, 22IBJ529, 22KBR876, 23BBA545, 23CBD715, 23CBQ582, 23DBH453, 23HBE012, 23HBR165, 23IBK906, 23KBP817, 24BBA648, 24DBD590, 24FBI859, 24GBU033, 24IBG868, 24JBI576;   4) REF DYNJ50692C, UDI/DI 10193489752199 (EA) 40193489752190 (CS), Lot Numbers:  19KDA566, 20BDC412, 20CDA575, 20GMD317, 21DMA002;   5) REF DYNJ54736B, UDI/DI 10889942925483 (EA) 40889942925484 (CS), Lot Numbers:  19ABB603, 19ABV222, 19CBN379, 19DBS122, 19EBZ894, 19FBQ049;   6) REF DYNJ82735, UDI/DI 10195327207540 (EA) 40195327207541 (CS), Lot Numbers:  22KMF252, 23EMG596, 23FMA429, 23IMA461, 23JMC236, 24BMC071;   7) REF DYNJ903144C, UDI/DI 10193489677881 (EA) 40193489677882 (CS), Lot Numbers:  19JBK003, 19SBD201, 20ABZ780, 20FBK295, 20GBR819, 20IBH005, 20LBK729, 20LBL461, 20LBO417, 20LBU129, 22AMA090, 22AMC790, 22BMF138, 22EMH876;   8) REF DYNJ905365A, UDI/DI 10193489759037 (EA) 40193489759038 (CS), Lot Numbers:  19IBR377, 20CBO773, 20GBI734, 20GBJ843, 20HBC012, 20IBQ906, 20JBO730, 21CBZ725, 21DBU031, 21GBF999, 21IBC232, 21VBB589;   9) REF DYNJ906474, UDI/DI 10193489750492 (EA) 40193489750493 (CS), Lot Numbers:  20ADB316, 20BDC489;   10) REF DYNJ906474A, UDI/DI 10193489344721 (EA) 40193489344722 (CS), Lot Numbers: 20EDC407, 20FDB425, 20HDA265, 20KDA931, 20KDC466, 21BDA054, 21EDA134, 21FDB465, 21GDB063, 21HDB526, 21IDA248;    11) REF DYNJ907802, UDI/DI 10193489890006 (EA) 40193489890007 (CS), Lot Numbers:  21GBI826, 22IBH914;   12) REF DYNJ907863, UDI/DI 10193489913187 (EA) 40193489913188 (CS), Lot Numbers:  21GBJ056, 21JBZ373, 21KBX700, 21LBV116;   13) REF DYNJ908264, UDI/DI 10195327020118 (EA) 40195327020119 (CS), Lot Numbers:  21LBU103.",
            "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"
          }
        }
      ]
    }
  ]
}