{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2704-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical procedure kits labeled as follows:    a) CYSTO, REF DYNJ905000D;   b) ENDO KIT, REF DYKE1462A;   c) ENDOSCOPY KIT, REF DYKE1431B;   d) ENDOSCOPY KIT, REF DYKE1623B;   e) GENERAL LAPAROSCOPY, REF DYNJ902385I;   f) GENERAL LAPAROSCOPY, REF DYNJ905508G;   g) GENERAL LAPAROSCOPY V, REF DYNJS2032D;   h) LAP APPY, REF DYNJ902383I;   i) LAP CHOLE, REF DYNJ9062767D;   j) LAP CHOLE, REF DYNJ907187A;   k) MAJOR, REF DYNJ904768B;   l) MAJOR, REF DYNJ905520F;   m) MAJOR, REF DYNJ907154A;   n) MAJOR SURGICAL, REF DYNJ905005C;   o) MINOR, REF DYNJ907155A;   p) MINOR SET UP, REF DYNJ909748;   q) RHYZOTOMY, REF DYNJ902288I;",
  "description": "FDA recall Z-2704-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline medical procedure kits labeled as follows:    a) CYSTO, REF DYNJ905000D;   b) ENDO KIT, REF DYKE1462A;   c) ENDOSCOPY KIT, REF DYKE1431B;   d) ENDOSCOPY KIT, REF DYKE1623B;   e) GENERAL LAPAROSCOPY, REF DYNJ902385I;   f) GENERAL LAPAROSCOPY, REF DYNJ905508G;   g) GENERAL LAPAROSCOPY V, REF DYNJS2032D;   h) LAP APPY, REF DYNJ902383I;   i) LAP CHOLE, REF DYNJ9062767D;   j) LAP CHOLE, REF DYNJ907187A;   k) MAJOR, REF DYNJ904768B;   l) MAJOR, REF DYNJ905520F;   m) MAJOR, REF DYNJ907154A;   n) MAJOR SURGICAL, REF DYNJ905005C;   o) MINOR, REF DYNJ907155A;   p) MINOR SET UP, REF DYNJ909748;   q) RHYZOTOMY, REF DYNJ902288I; (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/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2704-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical procedure kits labeled as follows:    a) CYSTO, REF DYNJ905000D;   b) ENDO KIT, REF DYKE1462A;   c) ENDOSCOPY KIT, REF DYKE1431B;   d) ENDOSCOPY KIT, REF DYKE1623B;   e) GENERAL LAPAROSCOPY, REF DYNJ902385I;   f) GENERAL LAPAROSCOPY, REF DYNJ905508G;   g) GENERAL LAPAROSCOPY V, REF DYNJS2032D;   h) LAP APPY, REF DYNJ902383I;   i) LAP CHOLE, REF DYNJ9062767D;   j) LAP CHOLE, REF DYNJ907187A;   k) MAJOR, REF DYNJ904768B;   l) MAJOR, REF DYNJ905520F;   m) MAJOR, REF DYNJ907154A;   n) MAJOR SURGICAL, REF DYNJ905005C;   o) MINOR, REF DYNJ907155A;   p) MINOR SET UP, REF DYNJ909748;   q) RHYZOTOMY, REF DYNJ902288I;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2704-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2704-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline medical procedure kits labeled as follows:    a) CYSTO, REF DYNJ905000D;   b) ENDO KIT, REF DYKE1462A;   c) ENDOSCOPY KIT, REF DYKE1431B;   d) ENDOSCOPY KIT, REF DYKE1623B;   e) GENERAL LAPAROSCOPY, REF DYNJ902385I;   f) GENERAL LAPAROSCOPY, REF DYNJ905508G;   g) GENERAL LAPAROSCOPY V, REF DYNJS2032D;   h) LAP APPY, REF DYNJ902383I;   i) LAP CHOLE, REF DYNJ9062767D;   j) LAP CHOLE, REF DYNJ907187A;   k) MAJOR, REF DYNJ904768B;   l) MAJOR, REF DYNJ905520F;   m) MAJOR, REF DYNJ907154A;   n) MAJOR SURGICAL, REF DYNJ905005C;   o) MINOR, REF DYNJ907155A;   p) MINOR SET UP, REF DYNJ909748;   q) RHYZOTOMY, REF DYNJ902288I;",
      "text": "The FDA logged enforcement record Z-2704-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline medical procedure kits labeled as follows:    a) CYSTO, REF DYNJ905000D;   b) ENDO KIT, REF DYKE1462A;   c) ENDOSCOPY KIT, REF DYKE1431B;   d) ENDOSCOPY KIT, REF DYKE1623B;   e) GENERAL LAPAROSCOPY, REF DYNJ902385I;   f) GENERAL LAPAROSCOPY, REF DYNJ905508G;   g) GENERAL LAPAROSCOPY V, REF DYNJS2032D;   h) LAP APPY, REF DYNJ902383I;   i) LAP CHOLE, REF DYNJ9062767D;   j) LAP CHOLE, REF DYNJ907187A;   k) MAJOR, REF DYNJ904768B;   l) MAJOR, REF DYNJ905520F;   m) MAJOR, REF DYNJ907154A;   n) MAJOR SURGICAL, REF DYNJ905005C;   o) MINOR, REF DYNJ907155A;   p) MINOR SET UP, REF DYNJ909748;   q) RHYZOTOMY, REF DYNJ902288I; — reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-22. Affected lots/codes: a) REF DYNJ905000D, UDI/DI 40195327316908 (case), 10195327316907 (unit), Lot Numbers:   23BBG363, 23CBN659, 23GBH840, 23HBE163, 23IBJ724, 23KBW116;   b) REF DYKE1462A, UDI/DI 40889942620167 (case), 10889942620166 (unit), Lot Numbers:   22FDC042, 22JDB988, 22LBJ315, 23BBL256, 23CBU426, 23EBH275, 23FBK205, 23IBF933;   c) REF DYKE1431B, UDI/DI 40889942632313 (case), 10889942632312 (unit), Lot Numbers:   22EME324, 22FMG304, 22HMH828, 22JMC383, 22LMC594, 23AMH794, 23BMF552, 23CME449, 23DMA460, 23FMF461, 23HMD372, 23JMB833, 23LMC072;   d) REF DYKE1623B, UDI/DI 40193489424943 (case), 10193489424942 (unit), Lot Numbers:  22EBN239, 22FBQ906, 22JBS556, 23ABD205, 23DBD052, 23FBD026, 23HBQ564, 23KBQ077;   e) REF DYNJ902385I, UDI/DI 40193489978279 (case), 10193489978278 (unit), Lot Numbers:  22IBL707, 23ABF810, 23ABS802, 23CBE830, 23CBM190, 23EBC428, 23FBU051, 23HBV225, 23KBR543;   f) REF DYNJ905508G, UDI/DI 40195327269075 (case), 10195327269074 (unit), Lot Numbers:  22LME748, 22LMF477, 22LMI027, 23AMB893, 23AMG865, 23EMA933, 23EMB427, 23GMB051, 23HMI600, 23IMG463, 23KMB250;    g) REF DYNJS2032D, UDI/DI 40193489214155 (case), 10193489214154 (unit), Lot Numbers:  22JDA825, 22LDB688, 23HDC128, 23KDA676;   h) REF DYNJ902383I, UDI/DI 40193488978590 (case), 10193489978599 (unit), Lot Numbers:  22FBF410, 22FBM118, 22GBV826, 22KBJ795, 22LBB636, 23ABM564, 23DBI048, 23EBJ423, 23FBC990, 23HBS791, 23JBR485, 23KBQ988;   i) REF DYNJ9062767D, UDI/DI 40195327511037 (case), 10195327511036 (unit), Lot Numbers:  23JBH731;   j) REF DYNJ907187A, UDI/DI 40193489970525 (case), 10193489970524 (unit), Lot Numbers:  22EMH533, 22FME336, 22LMB229, 23AME424, 23AMJ064;   k) REF DYNJ904768B, UDI/DI 40195327137183 (case), 10195327137182 (unit), Lot Numbers:  22EMG657, 22FMH099, 22IMA134, 22IMD626, 22JMF012, 23BMC481, 23BMG491, 23EMF946, 23GMB885, 23JMJ232, 23LMD177;   l) REF DYNJ905520F, UDI/DI 40195327421367 (case), 10195327421366 (unit), Lot Numbers:  23HME815, 23HMH202, 23IMA899, 23JMC171, 23KMH256;   m) REF DYNJ907154A, UDI/DI 40193489970341 (case), 10193489970340 (unit), Lot Numbers:  22FMH851, 22IMA525, 22LMF668, 23BMG402, 23DMD186, 23DME333, 23EMF068, 23HMD762, 23HMH492, 23KMC012;   n) REF DYNJ905005C, UDI/DI 40195327316946 (case), 10195327316945 (unit), Lot Numbers:  23ABL864, 23CBF410, 23DBF768, 23GBS885, 23IBD450;   o) REF DYNJ907155A, UDI/DI 40193489970273 (case), 10193489970272 (unit), Lot Numbers:  22KME231, 22LME429, 23AMF052, 23EMF507, 23JMA490;   p) REF DYNJ909748, UDI/DI 40195327468218 (case), 10195327468217 (unit), Lot Numbers:  23IMI101, 23KMB382;   q) REF DYNJ902288I, UDI/DI 40195327442225 (case), 10195327442224 (unit), Lot Numbers:  23GBD871, 23IBT374, 23KBD099;. 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-2704-2024&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-2704-2024&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-2704-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2704-2024 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-2704-2024&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-2704-2024&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-2704-2024/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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2704-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2704-2024",
            "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": "A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-03-22",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF DYNJ905000D, UDI/DI 40195327316908 (case), 10195327316907 (unit), Lot Numbers:   23BBG363, 23CBN659, 23GBH840, 23HBE163, 23IBJ724, 23KBW116;   b) REF DYKE1462A, UDI/DI 40889942620167 (case), 10889942620166 (unit), Lot Numbers:   22FDC042, 22JDB988, 22LBJ315, 23BBL256, 23CBU426, 23EBH275, 23FBK205, 23IBF933;   c) REF DYKE1431B, UDI/DI 40889942632313 (case), 10889942632312 (unit), Lot Numbers:   22EME324, 22FMG304, 22HMH828, 22JMC383, 22LMC594, 23AMH794, 23BMF552, 23CME449, 23DMA460, 23FMF461, 23HMD372, 23JMB833, 23LMC072;   d) REF DYKE1623B, UDI/DI 40193489424943 (case), 10193489424942 (unit), Lot Numbers:  22EBN239, 22FBQ906, 22JBS556, 23ABD205, 23DBD052, 23FBD026, 23HBQ564, 23KBQ077;   e) REF DYNJ902385I, UDI/DI 40193489978279 (case), 10193489978278 (unit), Lot Numbers:  22IBL707, 23ABF810, 23ABS802, 23CBE830, 23CBM190, 23EBC428, 23FBU051, 23HBV225, 23KBR543;   f) REF DYNJ905508G, UDI/DI 40195327269075 (case), 10195327269074 (unit), Lot Numbers:  22LME748, 22LMF477, 22LMI027, 23AMB893, 23AMG865, 23EMA933, 23EMB427, 23GMB051, 23HMI600, 23IMG463, 23KMB250;    g) REF DYNJS2032D, UDI/DI 40193489214155 (case), 10193489214154 (unit), Lot Numbers:  22JDA825, 22LDB688, 23HDC128, 23KDA676;   h) REF DYNJ902383I, UDI/DI 40193488978590 (case), 10193489978599 (unit), Lot Numbers:  22FBF410, 22FBM118, 22GBV826, 22KBJ795, 22LBB636, 23ABM564, 23DBI048, 23EBJ423, 23FBC990, 23HBS791, 23JBR485, 23KBQ988;   i) REF DYNJ9062767D, UDI/DI 40195327511037 (case), 10195327511036 (unit), Lot Numbers:  23JBH731;   j) REF DYNJ907187A, UDI/DI 40193489970525 (case), 10193489970524 (unit), Lot Numbers:  22EMH533, 22FME336, 22LMB229, 23AME424, 23AMJ064;   k) REF DYNJ904768B, UDI/DI 40195327137183 (case), 10195327137182 (unit), Lot Numbers:  22EMG657, 22FMH099, 22IMA134, 22IMD626, 22JMF012, 23BMC481, 23BMG491, 23EMF946, 23GMB885, 23JMJ232, 23LMD177;   l) REF DYNJ905520F, UDI/DI 40195327421367 (case), 10195327421366 (unit), Lot Numbers:  23HME815, 23HMH202, 23IMA899, 23JMC171, 23KMH256;   m) REF DYNJ907154A, UDI/DI 40193489970341 (case), 10193489970340 (unit), Lot Numbers:  22FMH851, 22IMA525, 22LMF668, 23BMG402, 23DMD186, 23DME333, 23EMF068, 23HMD762, 23HMH492, 23KMC012;   n) REF DYNJ905005C, UDI/DI 40195327316946 (case), 10195327316945 (unit), Lot Numbers:  23ABL864, 23CBF410, 23DBF768, 23GBS885, 23IBD450;   o) REF DYNJ907155A, UDI/DI 40193489970273 (case), 10193489970272 (unit), Lot Numbers:  22KME231, 22LME429, 23AMF052, 23EMF507, 23JMA490;   p) REF DYNJ909748, UDI/DI 40195327468218 (case), 10195327468217 (unit), Lot Numbers:  23IMI101, 23KMB382;   q) REF DYNJ902288I, UDI/DI 40195327442225 (case), 10195327442224 (unit), Lot Numbers:  23GBD871, 23IBT374, 23KBD099;",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}