{
  "@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-2442-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline procedure kits labeled as:    1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C;   2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C;   3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C;   4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928;   5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040;   6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097;   7) PAIN TRAY, Pack Number DYNJRA2230;   8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A;   9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856;   10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A;   11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047;   12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048",
  "description": "FDA recall Z-2442-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as:    1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C;   2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C;   3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C;   4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928;   5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040;   6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097;   7) PAIN TRAY, Pack Number DYNJRA2230;   8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A;   9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856;   10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A;   11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047;   12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048 (Devices, Class I). 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-2442-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline procedure kits labeled as:    1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C;   2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C;   3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C;   4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928;   5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040;   6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097;   7) PAIN TRAY, Pack Number DYNJRA2230;   8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A;   9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856;   10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A;   11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047;   12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2442-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2442-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as:    1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C;   2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C;   3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C;   4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928;   5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040;   6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097;   7) PAIN TRAY, Pack Number DYNJRA2230;   8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A;   9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856;   10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A;   11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047;   12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048",
      "text": "The FDA logged enforcement record Z-2442-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline procedure kits labeled as:    1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C;   2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C;   3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C;   4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928;   5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040;   6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097;   7) PAIN TRAY, Pack Number DYNJRA2230;   8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A;   9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856;   10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A;   11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047;   12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048 — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: DYNJRA0960C    , Lot Number 23CBH823 ;  DYNJRA0960C    , Lot Number 23EBC905 ;  DYNJRA0960C    , Lot Number 23EBV028 ;  DYNJRA0960C    , Lot Number 23HBO071 ;  DYNJRA0960C    , Lot Number 24BBI322 ;  DYNJRA1268C    , Lot Number 22GLB081 ;  DYNJRA1268C    , Lot Number 22HLA566 ;  DYNJRA1268C    , Lot Number 22ILA092 ;  DYNJRA1268C    , Lot Number 22LLA800 ;  DYNJRA1268C    , Lot Number 23DLA368 ;  DYNJRA1268C    , Lot Number 23FLA942 ;  DYNJRA1268C    , Lot Number 23GLA321 ;  DYNJRA1268C    , Lot Number 23HLA910 ;  DYNJRA1268C    , Lot Number 23ILA593 ;  DYNJRA1638C    , Lot Number 23EBA854 ;  DYNJRA1638C    , Lot Number 23GBE493 ;  DYNJRA1638C    , Lot Number 23KBJ159 ;  DYNJRA1928     , Lot Number 22EBD354 ;  DYNJRA1928     , Lot Number 22JBO947 ;  DYNJRA1928     , Lot Number 23CBO440 ;  DYNJRA1928     , Lot Number 23HBK783 ;  DYNJRA1928     , Lot Number 23JBI435 ;  DYNJRA1928     , Lot Number 23LBM602 ;  DYNJRA1928     , Lot Number 24ABQ693 ;  DYNJRA2040     , Lot Number 23CBH893 ;  DYNJRA2040     , Lot Number 23HBX547 ;  DYNJRA2040     , Lot Number 23JBN538 ;  DYNJRA2040     , Lot Number 24ABQ696 ;  DYNJRA2040     , Lot Number 24CBG746 ;  DYNJRA2097     , Lot Number 23BBO995 ;  DYNJRA2230     , Lot Number 23JBU321 ;  DYNJRA2230     , Lot Number 23LBC389 ;  PAIN1766A      , Lot Number 23FLB123 ;  PAIN1766A      , Lot Number 23GLA313 ;  PAIN1766A      , Lot Number 24ALA302 ;  PAIN1766A      , Lot Number 24BLA659 ;  PAIN1766A      , Lot Number 24BLA888 ;  PAIN1766A      , Lot Number 24BLA889 ;  PAIN1766A      , Lot Number 24BLA998 ;  PAIN1766A      , Lot Number 24CLA003 ;  PAIN1766A      , Lot Number 24CLA078 ;  PAIN1856       , Lot Number 22JLB162 ;  PAIN1856       , Lot Number 22LLA409 ;  PAIN1856A      , Lot Number 23HLB303 ;  PAIN1856A      , Lot Number 24BLB005 ;  PAIN1856A      , Lot Number 24BLA682 ;  PAIN2047       , Lot Number 24BBH932 ;  PAIN2048       , Lot Number 24BBF612. 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-2442-2024&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-2442-2024&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-2442-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2442-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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-2442-2024&lang=eng",
        "value": "Class I",
        "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-2442-2024&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-2442-2024/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-2442-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2442-2024",
            "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 I",
            "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": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-04-08",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "DYNJRA0960C    , Lot Number 23CBH823 ;  DYNJRA0960C    , Lot Number 23EBC905 ;  DYNJRA0960C    , Lot Number 23EBV028 ;  DYNJRA0960C    , Lot Number 23HBO071 ;  DYNJRA0960C    , Lot Number 24BBI322 ;  DYNJRA1268C    , Lot Number 22GLB081 ;  DYNJRA1268C    , Lot Number 22HLA566 ;  DYNJRA1268C    , Lot Number 22ILA092 ;  DYNJRA1268C    , Lot Number 22LLA800 ;  DYNJRA1268C    , Lot Number 23DLA368 ;  DYNJRA1268C    , Lot Number 23FLA942 ;  DYNJRA1268C    , Lot Number 23GLA321 ;  DYNJRA1268C    , Lot Number 23HLA910 ;  DYNJRA1268C    , Lot Number 23ILA593 ;  DYNJRA1638C    , Lot Number 23EBA854 ;  DYNJRA1638C    , Lot Number 23GBE493 ;  DYNJRA1638C    , Lot Number 23KBJ159 ;  DYNJRA1928     , Lot Number 22EBD354 ;  DYNJRA1928     , Lot Number 22JBO947 ;  DYNJRA1928     , Lot Number 23CBO440 ;  DYNJRA1928     , Lot Number 23HBK783 ;  DYNJRA1928     , Lot Number 23JBI435 ;  DYNJRA1928     , Lot Number 23LBM602 ;  DYNJRA1928     , Lot Number 24ABQ693 ;  DYNJRA2040     , Lot Number 23CBH893 ;  DYNJRA2040     , Lot Number 23HBX547 ;  DYNJRA2040     , Lot Number 23JBN538 ;  DYNJRA2040     , Lot Number 24ABQ696 ;  DYNJRA2040     , Lot Number 24CBG746 ;  DYNJRA2097     , Lot Number 23BBO995 ;  DYNJRA2230     , Lot Number 23JBU321 ;  DYNJRA2230     , Lot Number 23LBC389 ;  PAIN1766A      , Lot Number 23FLB123 ;  PAIN1766A      , Lot Number 23GLA313 ;  PAIN1766A      , Lot Number 24ALA302 ;  PAIN1766A      , Lot Number 24BLA659 ;  PAIN1766A      , Lot Number 24BLA888 ;  PAIN1766A      , Lot Number 24BLA889 ;  PAIN1766A      , Lot Number 24BLA998 ;  PAIN1766A      , Lot Number 24CLA003 ;  PAIN1766A      , Lot Number 24CLA078 ;  PAIN1856       , Lot Number 22JLB162 ;  PAIN1856       , Lot Number 22LLA409 ;  PAIN1856A      , Lot Number 23HLB303 ;  PAIN1856A      , Lot Number 24BLB005 ;  PAIN1856A      , Lot Number 24BLA682 ;  PAIN2047       , Lot Number 24BBH932 ;  PAIN2048       , Lot Number 24BBF612",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}