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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0527-2026.jsonld",
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  "name": "MEDLINE convenience kits labeled as:    1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O;   3) MINOR VAGINAL #76-RF, REF DYNJ27434R;   4) ABDOMINAL HYST PACK, REF DYNJ44848M;   5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   7) URO GYN, REF DYNJ50047G;   8) ISS VAG HYST PACK, REF DYNJ50315F;   9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B;   10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B;   11) LAVH, REF DYNJ900298L;   12) LITHOTOMY-LF, REF DYNJ900721C;   13) GP-T A H PACK-LF, REF PHS396954006G;   14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F.",
  "description": "FDA recall Z-0527-2026 — Medline Industries, LP is recalling MEDLINE convenience kits labeled as:    1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O;   3) MINOR VAGINAL #76-RF, REF DYNJ27434R;   4) ABDOMINAL HYST PACK, REF DYNJ44848M;   5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   7) URO GYN, REF DYNJ50047G;   8) ISS VAG HYST PACK, REF DYNJ50315F;   9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B;   10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B;   11) LAVH, REF DYNJ900298L;   12) LITHOTOMY-LF, REF DYNJ900721C;   13) GP-T A H PACK-LF, REF PHS396954006G;   14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F. (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-0527-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MEDLINE convenience kits labeled as:    1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O;   3) MINOR VAGINAL #76-RF, REF DYNJ27434R;   4) ABDOMINAL HYST PACK, REF DYNJ44848M;   5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   7) URO GYN, REF DYNJ50047G;   8) ISS VAG HYST PACK, REF DYNJ50315F;   9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B;   10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B;   11) LAVH, REF DYNJ900298L;   12) LITHOTOMY-LF, REF DYNJ900721C;   13) GP-T A H PACK-LF, REF PHS396954006G;   14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0527-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0527-2026: Medline Industries, LP is recalling MEDLINE convenience kits labeled as:    1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O;   3) MINOR VAGINAL #76-RF, REF DYNJ27434R;   4) ABDOMINAL HYST PACK, REF DYNJ44848M;   5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   7) URO GYN, REF DYNJ50047G;   8) ISS VAG HYST PACK, REF DYNJ50315F;   9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B;   10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B;   11) LAVH, REF DYNJ900298L;   12) LITHOTOMY-LF, REF DYNJ900721C;   13) GP-T A H PACK-LF, REF PHS396954006G;   14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F.",
      "text": "The FDA logged enforcement record Z-0527-2026: Medline Industries, LP is voluntarily recalling MEDLINE convenience kits labeled as:    1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O;   3) MINOR VAGINAL #76-RF, REF DYNJ27434R;   4) ABDOMINAL HYST PACK, REF DYNJ44848M;   5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   7) URO GYN, REF DYNJ50047G;   8) ISS VAG HYST PACK, REF DYNJ50315F;   9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B;   10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B;   11) LAVH, REF DYNJ900298L;   12) LITHOTOMY-LF, REF DYNJ900721C;   13) GP-T A H PACK-LF, REF PHS396954006G;   14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F. — reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-30. Affected lots/codes: 1) REF DYNJ0160684F:  UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers:  23DDC245, 23GDC219;   2) REF DYNJ0425778O:  UDI/DI 10198459082290 (each) 40198459082291 (case), Lot Numbers:  24LMF192;   3) REF DYNJ27434R:  UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers:  24BBR389, 24CBH709;   4) REF DYNJ44848M:  UDI/DI 10195327415952 (each) 40195327415953 (case), Lot Numbers:  23EDB911, 23FDC315, 23HDA180;   5) REF DYNJ44863Q:  UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers: 23FDB122, 23GDC100;    6) REF DYNJ44900P:  UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers: 23DDB824, 23EDA215, 23FDB287;    7) REF DYNJ50047G:  UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers: 24BBE163, 24DBO682;    8) REF DYNJ50315F:  UDI/DI 10195327535353 (each) 40195327535354 (case), Lot Numbers:  23KMF190;   9) REF DYNJ60554B:  UDI/DI 10195327361747 (each) 40195327361748 (case), Lot Numbers:  23EBD224, 23KBE886;   10) REF DYNJ67194B:  UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers:  23HBN435;   11) REF DYNJ900298L:  UDI/DI 10195327554170 (each) 40195327554171 (case), Lot Numbers:  23LBF269, 23LBT933, 24BBT248;   12) REF DYNJ900721C:  UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers:  23HBW996;   13) REF PHS396954006G:  UDI/DI 10195327454159 (each) 40195327454150 (case), Lot Numbers:  23HDB088;   14) REF PHS396975006F:  UDI/DI 10195327454166 (each) 40195327454167 (case), Lot Numbers:  23JDB593.. 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-0527-2026&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-0527-2026&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-0527-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0527-2026 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-0527-2026&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-0527-2026&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-0527-2026/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-0527-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0527-2026",
            "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",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-09-30",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) REF DYNJ0160684F:  UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers:  23DDC245, 23GDC219;   2) REF DYNJ0425778O:  UDI/DI 10198459082290 (each) 40198459082291 (case), Lot Numbers:  24LMF192;   3) REF DYNJ27434R:  UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers:  24BBR389, 24CBH709;   4) REF DYNJ44848M:  UDI/DI 10195327415952 (each) 40195327415953 (case), Lot Numbers:  23EDB911, 23FDC315, 23HDA180;   5) REF DYNJ44863Q:  UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers: 23FDB122, 23GDC100;    6) REF DYNJ44900P:  UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers: 23DDB824, 23EDA215, 23FDB287;    7) REF DYNJ50047G:  UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers: 24BBE163, 24DBO682;    8) REF DYNJ50315F:  UDI/DI 10195327535353 (each) 40195327535354 (case), Lot Numbers:  23KMF190;   9) REF DYNJ60554B:  UDI/DI 10195327361747 (each) 40195327361748 (case), Lot Numbers:  23EBD224, 23KBE886;   10) REF DYNJ67194B:  UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers:  23HBN435;   11) REF DYNJ900298L:  UDI/DI 10195327554170 (each) 40195327554171 (case), Lot Numbers:  23LBF269, 23LBT933, 24BBT248;   12) REF DYNJ900721C:  UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers:  23HBW996;   13) REF PHS396954006G:  UDI/DI 10195327454159 (each) 40195327454150 (case), Lot Numbers:  23HDB088;   14) REF PHS396975006F:  UDI/DI 10195327454166 (each) 40195327454167 (case), Lot Numbers:  23JDB593.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}