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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2708-2024.jsonld",
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  "name": "Medline medical procedure kits labeled as follows:    a) AAA CDS, REF CDS984011C;   b) CAN KIT, REF DYKM1184;   c) DENTAL CDS, REF CDS984010B;   d) EGD KIT, REF DYK1253578F;   e) EGD  REG KIT, REF DYKE1830;   f) ENDO KIT, REF DYKE1516A;   g) ERCP  REG KIT, REF DYKM2127;   h) GI PACK, REF DYKE1898;   i) KIT, PEG,  REG, REF DYKM2128;   j) KIT,1500CC, 50CS, REF DYKM2126;   k) LITHOTOMY, REF DYNJ909937;   l) MAJOR BASIC, REF DYNJ909703;   m) MINOR GENERAL SURGERY, REF DYNJ909940;   n) SUCTION SET UP KIT, REF DYKM1187A;   o) TURNOVER KIT, REF DYKC1274A;   p) TURNOVER KIT MKT STRAPS, REF DYKC1309A;   q) U BAR, REF DYNJ902374K",
  "description": "FDA recall Z-2708-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline medical procedure kits labeled as follows:    a) AAA CDS, REF CDS984011C;   b) CAN KIT, REF DYKM1184;   c) DENTAL CDS, REF CDS984010B;   d) EGD KIT, REF DYK1253578F;   e) EGD  REG KIT, REF DYKE1830;   f) ENDO KIT, REF DYKE1516A;   g) ERCP  REG KIT, REF DYKM2127;   h) GI PACK, REF DYKE1898;   i) KIT, PEG,  REG, REF DYKM2128;   j) KIT,1500CC, 50CS, REF DYKM2126;   k) LITHOTOMY, REF DYNJ909937;   l) MAJOR BASIC, REF DYNJ909703;   m) MINOR GENERAL SURGERY, REF DYNJ909940;   n) SUCTION SET UP KIT, REF DYKM1187A;   o) TURNOVER KIT, REF DYKC1274A;   p) TURNOVER KIT MKT STRAPS, REF DYKC1309A;   q) U BAR, REF DYNJ902374K (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",
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    "@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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2708-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical procedure kits labeled as follows:    a) AAA CDS, REF CDS984011C;   b) CAN KIT, REF DYKM1184;   c) DENTAL CDS, REF CDS984010B;   d) EGD KIT, REF DYK1253578F;   e) EGD  REG KIT, REF DYKE1830;   f) ENDO KIT, REF DYKE1516A;   g) ERCP  REG KIT, REF DYKM2127;   h) GI PACK, REF DYKE1898;   i) KIT, PEG,  REG, REF DYKM2128;   j) KIT,1500CC, 50CS, REF DYKM2126;   k) LITHOTOMY, REF DYNJ909937;   l) MAJOR BASIC, REF DYNJ909703;   m) MINOR GENERAL SURGERY, REF DYNJ909940;   n) SUCTION SET UP KIT, REF DYKM1187A;   o) TURNOVER KIT, REF DYKC1274A;   p) TURNOVER KIT MKT STRAPS, REF DYKC1309A;   q) U BAR, REF DYNJ902374K",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2708-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2708-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline medical procedure kits labeled as follows:    a) AAA CDS, REF CDS984011C;   b) CAN KIT, REF DYKM1184;   c) DENTAL CDS, REF CDS984010B;   d) EGD KIT, REF DYK1253578F;   e) EGD  REG KIT, REF DYKE1830;   f) ENDO KIT, REF DYKE1516A;   g) ERCP  REG KIT, REF DYKM2127;   h) GI PACK, REF DYKE1898;   i) KIT, PEG,  REG, REF DYKM2128;   j) KIT,1500CC, 50CS, REF DYKM2126;   k) LITHOTOMY, REF DYNJ909937;   l) MAJOR BASIC, REF DYNJ909703;   m) MINOR GENERAL SURGERY, REF DYNJ909940;   n) SUCTION SET UP KIT, REF DYKM1187A;   o) TURNOVER KIT, REF DYKC1274A;   p) TURNOVER KIT MKT STRAPS, REF DYKC1309A;   q) U BAR, REF DYNJ902374K",
      "text": "The FDA logged enforcement record Z-2708-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline medical procedure kits labeled as follows:    a) AAA CDS, REF CDS984011C;   b) CAN KIT, REF DYKM1184;   c) DENTAL CDS, REF CDS984010B;   d) EGD KIT, REF DYK1253578F;   e) EGD  REG KIT, REF DYKE1830;   f) ENDO KIT, REF DYKE1516A;   g) ERCP  REG KIT, REF DYKM2127;   h) GI PACK, REF DYKE1898;   i) KIT, PEG,  REG, REF DYKM2128;   j) KIT,1500CC, 50CS, REF DYKM2126;   k) LITHOTOMY, REF DYNJ909937;   l) MAJOR BASIC, REF DYNJ909703;   m) MINOR GENERAL SURGERY, REF DYNJ909940;   n) SUCTION SET UP KIT, REF DYKM1187A;   o) TURNOVER KIT, REF DYKC1274A;   p) TURNOVER KIT MKT STRAPS, REF DYKC1309A;   q) U BAR, REF DYNJ902374K — 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 CDS984011C, UDI/DI 40889942325796 (case), 10889942325795 (unit), Lot Numbers:   22EBC452, 22FBX932, 22GBR344, 22HBG632, 22JBR362, 22KBE842, 23EBU748, 23KBF372;   b) REF DYKM1184, UDI/DI 40888277877024 (case), 10888277877023 (unit), Lot Numbers:   22FMF770, 22HMF787, 22IMH596, 22KMH402, 22LMG049, 23AMH718, 23BME929, 23BMG061, 23DME554, 23FMI657, 23GMH363, 23IMH597, 23JMB834, 23KMD766;   c) REF CDS984010B, UDI/DI 40889942279372 (case), 10889942279371 (unit), Lot Numbers:   22HBM538, 22IBT843, 22KBK453, 23ABM855, 23DBT392, 23KBL270;   d) REF DYK1253578F, UDI/DI 40889942925354 (case), 10889942925353 (unit), Lot Numbers:   22FMH475, 22GMD228, 22HMH211, 22HMH348, 22LMC603, 23BMD249, 23DMB067, 23EMJ898, 23FMF457, 23GMG743, 23JME993, 23KMB182, 23LMA953  e) REF DYKE1830, UDI/DI 40195327044207 (case), 10195327044206 (unit), Lot Numbers:   22FLA559, 22GLA591, 22ILA148, 23DLA944, 23ELB067, 23FLA478, 23GLA202, 23GLB207, 23HLA568, 23KLB137;   f) REF DYKE1516A, UDI/DI 40889942805748 (case), 10889942805747 (unit), Lot Numbers:   22EBF069, 22FBC759, 22GBW830, 22HBU819, 22IBU640, 22LBC023, 23ABP313, 23BBR036, 23EBF437, 23FBD820, 23GBA762, 23HBK499, 23JBF970, 23KBE276;   g) REF DYKM2127, UDI/DI 40195327045013 (case), 10195327045012 (unit), Lot Numbers:   22FLA082, 23KLB138;   h) REF DYKE1898, UDI/DI 40195327314713 (case), 10195327314712 (unit), Lot Numbers:   23BBS475, 23EBM141, 23GBJ917, 23IBN380, 23JBB065, 23KBK719;   i) REF DYKM2128, UDI/DI 40195327045037 (case), 10195327045036 (unit), Lot Numbers:   22GLA027;   j) REF DYKM2126, UDI/DI 40195327044979 (case), 10195327044978 (unit), Lot Numbers:   22FBD067, 22FBW468, 22JBW467, 22KBS235, 23BBI456, 23DBO780, 23EBX215, 23HBP435, 23JBI233;   k) REF DYNJ909937, UDI/DI 40195327511211 (case), 10195327511210 (unit), Lot Numbers:  23JBJ444, 23KBF560, 23LBE395;  l) REF DYNJ909703, UDI/DI 40195327446902 (case), 10195327446901 (unit), Lot Numbers:  23HBQ115, 23JBG416, 23KBU600;   m) REF DYNJ909940, UDI/DI 40195327510993 (case), 10195327510992 (unit), Lot Numbers:  23JBH986;   n) REF DYKM1187A, UDI/DI 40193489244732 (case), 10193489244731 (unit), Lot Numbers:  22EMC363, 22FMD877, 22FMF873, 22HMF347, 22JMD898, 23AMA723, 23AMH732, 23BMI255, 23CME984, 23FMB442, 23GMC961, 23HMA663, 23JMB772;   o) REF DYKC1274A, UDI/DI 40889942750154 (case), 10889942750153 (unit), Lot Numbers:   22FMA812, 22HMH967, 22LMD953, 23DMA533, 23EMH949, 23GMH687, 23JMJ195;   p) REF DYKC1309A, UDI/DI 40888277745903 (case), 10888277745902 (unit), Lot Numbers:  DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A;   q) REF DYNJ902374K, UDI/DI 40195327505845 (case), 10195327505844 (unit), Lot Numbers:  23JBK113, 23KBO175, 23LBA437. 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-2708-2024&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-2708-2024&lang=eng"
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      },
      "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-2708-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2708-2024 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-2708-2024&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-2708-2024&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-2708-2024/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": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2708-2024",
      "numberOfItems": 9,
      "itemListElement": [
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2708-2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        {
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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 - Northfield",
            "Status": "recorded"
          }
        },
        {
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          "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"
          }
        },
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF CDS984011C, UDI/DI 40889942325796 (case), 10889942325795 (unit), Lot Numbers:   22EBC452, 22FBX932, 22GBR344, 22HBG632, 22JBR362, 22KBE842, 23EBU748, 23KBF372;   b) REF DYKM1184, UDI/DI 40888277877024 (case), 10888277877023 (unit), Lot Numbers:   22FMF770, 22HMF787, 22IMH596, 22KMH402, 22LMG049, 23AMH718, 23BME929, 23BMG061, 23DME554, 23FMI657, 23GMH363, 23IMH597, 23JMB834, 23KMD766;   c) REF CDS984010B, UDI/DI 40889942279372 (case), 10889942279371 (unit), Lot Numbers:   22HBM538, 22IBT843, 22KBK453, 23ABM855, 23DBT392, 23KBL270;   d) REF DYK1253578F, UDI/DI 40889942925354 (case), 10889942925353 (unit), Lot Numbers:   22FMH475, 22GMD228, 22HMH211, 22HMH348, 22LMC603, 23BMD249, 23DMB067, 23EMJ898, 23FMF457, 23GMG743, 23JME993, 23KMB182, 23LMA953  e) REF DYKE1830, UDI/DI 40195327044207 (case), 10195327044206 (unit), Lot Numbers:   22FLA559, 22GLA591, 22ILA148, 23DLA944, 23ELB067, 23FLA478, 23GLA202, 23GLB207, 23HLA568, 23KLB137;   f) REF DYKE1516A, UDI/DI 40889942805748 (case), 10889942805747 (unit), Lot Numbers:   22EBF069, 22FBC759, 22GBW830, 22HBU819, 22IBU640, 22LBC023, 23ABP313, 23BBR036, 23EBF437, 23FBD820, 23GBA762, 23HBK499, 23JBF970, 23KBE276;   g) REF DYKM2127, UDI/DI 40195327045013 (case), 10195327045012 (unit), Lot Numbers:   22FLA082, 23KLB138;   h) REF DYKE1898, UDI/DI 40195327314713 (case), 10195327314712 (unit), Lot Numbers:   23BBS475, 23EBM141, 23GBJ917, 23IBN380, 23JBB065, 23KBK719;   i) REF DYKM2128, UDI/DI 40195327045037 (case), 10195327045036 (unit), Lot Numbers:   22GLA027;   j) REF DYKM2126, UDI/DI 40195327044979 (case), 10195327044978 (unit), Lot Numbers:   22FBD067, 22FBW468, 22JBW467, 22KBS235, 23BBI456, 23DBO780, 23EBX215, 23HBP435, 23JBI233;   k) REF DYNJ909937, UDI/DI 40195327511211 (case), 10195327511210 (unit), Lot Numbers:  23JBJ444, 23KBF560, 23LBE395;  l) REF DYNJ909703, UDI/DI 40195327446902 (case), 10195327446901 (unit), Lot Numbers:  23HBQ115, 23JBG416, 23KBU600;   m) REF DYNJ909940, UDI/DI 40195327510993 (case), 10195327510992 (unit), Lot Numbers:  23JBH986;   n) REF DYKM1187A, UDI/DI 40193489244732 (case), 10193489244731 (unit), Lot Numbers:  22EMC363, 22FMD877, 22FMF873, 22HMF347, 22JMD898, 23AMA723, 23AMH732, 23BMI255, 23CME984, 23FMB442, 23GMC961, 23HMA663, 23JMB772;   o) REF DYKC1274A, UDI/DI 40889942750154 (case), 10889942750153 (unit), Lot Numbers:   22FMA812, 22HMH967, 22LMD953, 23DMA533, 23EMH949, 23GMH687, 23JMJ195;   p) REF DYKC1309A, UDI/DI 40888277745903 (case), 10888277745902 (unit), Lot Numbers:  DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A;   q) REF DYNJ902374K, UDI/DI 40195327505845 (case), 10195327505844 (unit), Lot Numbers:  23JBK113, 23KBO175, 23LBA437",
            "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"
          }
        }
      ]
    }
  ]
}