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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0177-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline brand medical procedure convenience kits, labeled as:    a) OB PACK-LF, REF DYNJ0912449M;   b) OB PACK, REF DYNJ17309G;   c) OB PK, REF DYNJ34268D;   d) OB DELIVERY PACK, REF DYNJ34274B;   e) OB DELIVERY PACK, REF DYNJ34274B;   f) D AND C PACK, REF DYNJ39668I;   g) OB PACK, REF DYNJ42884;   h) RFT D & C PACK, REF DYNJ50851;   i) KIT OB, REF DYNJ906623;   j) D AND C, REF DYNJ907957A;   k) CHS OB PACK III, REF DYNJCH907",
  "description": "FDA recall Z-0177-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline brand medical procedure convenience kits, labeled as:    a) OB PACK-LF, REF DYNJ0912449M;   b) OB PACK, REF DYNJ17309G;   c) OB PK, REF DYNJ34268D;   d) OB DELIVERY PACK, REF DYNJ34274B;   e) OB DELIVERY PACK, REF DYNJ34274B;   f) D AND C PACK, REF DYNJ39668I;   g) OB PACK, REF DYNJ42884;   h) RFT D & C PACK, REF DYNJ50851;   i) KIT OB, REF DYNJ906623;   j) D AND C, REF DYNJ907957A;   k) CHS OB PACK III, REF DYNJCH907 (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",
    "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-0177-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline brand medical procedure convenience kits, labeled as:    a) OB PACK-LF, REF DYNJ0912449M;   b) OB PACK, REF DYNJ17309G;   c) OB PK, REF DYNJ34268D;   d) OB DELIVERY PACK, REF DYNJ34274B;   e) OB DELIVERY PACK, REF DYNJ34274B;   f) D AND C PACK, REF DYNJ39668I;   g) OB PACK, REF DYNJ42884;   h) RFT D & C PACK, REF DYNJ50851;   i) KIT OB, REF DYNJ906623;   j) D AND C, REF DYNJ907957A;   k) CHS OB PACK III, REF DYNJCH907",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0177-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0177-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline brand medical procedure convenience kits, labeled as:    a) OB PACK-LF, REF DYNJ0912449M;   b) OB PACK, REF DYNJ17309G;   c) OB PK, REF DYNJ34268D;   d) OB DELIVERY PACK, REF DYNJ34274B;   e) OB DELIVERY PACK, REF DYNJ34274B;   f) D AND C PACK, REF DYNJ39668I;   g) OB PACK, REF DYNJ42884;   h) RFT D & C PACK, REF DYNJ50851;   i) KIT OB, REF DYNJ906623;   j) D AND C, REF DYNJ907957A;   k) CHS OB PACK III, REF DYNJCH907",
      "text": "The FDA logged enforcement record Z-0177-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline brand medical procedure convenience kits, labeled as:    a) OB PACK-LF, REF DYNJ0912449M;   b) OB PACK, REF DYNJ17309G;   c) OB PK, REF DYNJ34268D;   d) OB DELIVERY PACK, REF DYNJ34274B;   e) OB DELIVERY PACK, REF DYNJ34274B;   f) D AND C PACK, REF DYNJ39668I;   g) OB PACK, REF DYNJ42884;   h) RFT D & C PACK, REF DYNJ50851;   i) KIT OB, REF DYNJ906623;   j) D AND C, REF DYNJ907957A;   k) CHS OB PACK III, REF DYNJCH907 — reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-09-04. Affected lots/codes: a) REF DYNJ0912449M, UDI/DI 40889942437536 (each), 10889942437535 (case), Lot Numbers:  23LBP185;  b) REF DYNJ17309G, UDI/DI 40193489277181 (each), 10193489277180 (case), Lot Numbers:  24ABB399;  c) REF DYNJ34268D, UDI/DI 40193489821421 (each), 10193489821420 (case), Lot Numbers:  23LBM844;  d) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers:  23LBS099;  e) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers:  23KBB869;  f) REF DYNJ39668I, UDI/DI 40195327456284 (each), 10195327456283 (case), Lot Numbers:  23LBM868;  g) REF DYNJ42884, UDI/DI 40888277011077 (each), 10888277011076 (case), Lot Numbers:  23KBB574;  h) REF DYNJ50851, UDI/DI 40889942029014 (each), 10889942029013 (case), Lot Numbers:  23LBL975;  i) REF DYNJ906623, UDI/DI 40193489794695 (each), 10193489794694 (case), Lot Numbers:  24ABE587;  j) REF DYNJ907957A, UDI/DI 40195327189854 (each), 10195327189853 (case), Lot Numbers:  24BBA954;  k) REF DYNJCH907, UDI/DI 40193489391979 (each), 10193489391978 (case), Lot Numbers:  24ABC904. 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-0177-2025&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-0177-2025&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-0177-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0177-2025 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
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      "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-0177-2025&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-0177-2025&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-0177-2025/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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0177-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0177-2025",
            "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": "It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-09-04",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF DYNJ0912449M, UDI/DI 40889942437536 (each), 10889942437535 (case), Lot Numbers:  23LBP185;  b) REF DYNJ17309G, UDI/DI 40193489277181 (each), 10193489277180 (case), Lot Numbers:  24ABB399;  c) REF DYNJ34268D, UDI/DI 40193489821421 (each), 10193489821420 (case), Lot Numbers:  23LBM844;  d) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers:  23LBS099;  e) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers:  23KBB869;  f) REF DYNJ39668I, UDI/DI 40195327456284 (each), 10195327456283 (case), Lot Numbers:  23LBM868;  g) REF DYNJ42884, UDI/DI 40888277011077 (each), 10888277011076 (case), Lot Numbers:  23KBB574;  h) REF DYNJ50851, UDI/DI 40889942029014 (each), 10889942029013 (case), Lot Numbers:  23LBL975;  i) REF DYNJ906623, UDI/DI 40193489794695 (each), 10193489794694 (case), Lot Numbers:  24ABE587;  j) REF DYNJ907957A, UDI/DI 40195327189854 (each), 10195327189853 (case), Lot Numbers:  24BBA954;  k) REF DYNJCH907, UDI/DI 40193489391979 (each), 10193489391978 (case), Lot Numbers:  24ABC904",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Panama.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}