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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1089-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical procedure convenience kits labeled as:    1) LAVH PROCEDURE, REF CDS980754T;   2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q;   3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F;   4) LAVH, REF DYNJQ9041R;   5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I;   6) ROBOTIC LAVH, REF DYNJ901281I;   7) LAVH-LF, REF DYNJ901829T;   8) LEX LAP HYST, REF DYNJ902030J;   9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D;   10) GYN LAPAROSCOPY, REF DYNJ905485J;   11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C;   12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634;   13) LAVH GYN/ONC, REF DYNJ910927.",
  "description": "FDA recall Z-1089-2026 — Medline Industries, LP is recalling Medline medical procedure convenience kits labeled as:    1) LAVH PROCEDURE, REF CDS980754T;   2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q;   3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F;   4) LAVH, REF DYNJQ9041R;   5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I;   6) ROBOTIC LAVH, REF DYNJ901281I;   7) LAVH-LF, REF DYNJ901829T;   8) LEX LAP HYST, REF DYNJ902030J;   9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D;   10) GYN LAPAROSCOPY, REF DYNJ905485J;   11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C;   12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634;   13) LAVH GYN/ONC, REF DYNJ910927. (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/",
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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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1089-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical procedure convenience kits labeled as:    1) LAVH PROCEDURE, REF CDS980754T;   2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q;   3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F;   4) LAVH, REF DYNJQ9041R;   5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I;   6) ROBOTIC LAVH, REF DYNJ901281I;   7) LAVH-LF, REF DYNJ901829T;   8) LEX LAP HYST, REF DYNJ902030J;   9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D;   10) GYN LAPAROSCOPY, REF DYNJ905485J;   11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C;   12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634;   13) LAVH GYN/ONC, REF DYNJ910927.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1089-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1089-2026: Medline Industries, LP is recalling Medline medical procedure convenience kits labeled as:    1) LAVH PROCEDURE, REF CDS980754T;   2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q;   3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F;   4) LAVH, REF DYNJQ9041R;   5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I;   6) ROBOTIC LAVH, REF DYNJ901281I;   7) LAVH-LF, REF DYNJ901829T;   8) LEX LAP HYST, REF DYNJ902030J;   9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D;   10) GYN LAPAROSCOPY, REF DYNJ905485J;   11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C;   12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634;   13) LAVH GYN/ONC, REF DYNJ910927.",
      "text": "The FDA logged enforcement record Z-1089-2026: Medline Industries, LP is voluntarily recalling Medline medical procedure convenience kits labeled as:    1) LAVH PROCEDURE, REF CDS980754T;   2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q;   3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F;   4) LAVH, REF DYNJQ9041R;   5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I;   6) ROBOTIC LAVH, REF DYNJ901281I;   7) LAVH-LF, REF DYNJ901829T;   8) LEX LAP HYST, REF DYNJ902030J;   9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D;   10) GYN LAPAROSCOPY, REF DYNJ905485J;   11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C;   12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634;   13) LAVH GYN/ONC, REF DYNJ910927. — reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-16. Affected lots/codes: REF CDS980754T:  UDI/DI 10198459121814 (EA) 40198459121815 (CS), Lot Number 25EMD795;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBR237;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBP591;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25DBM353;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25CBL184;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25BBL633;  REF CDS985344F:  UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25FBK918;  REF CDS985344F:  UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25CBJ496;  REF DYNJQ9041R:  UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25FBF371;  REF DYNJQ9041R:  UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25EBK493;  REF DYNJQ9041R:  UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25DBH895;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25DBC272;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBU642;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBJ298;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25BBU206;  REF DYNJ901281I:  UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25FBA261;  REF DYNJ901281I:  UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25CBN230;  REF DYNJ901829T:  UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25FDB398;  REF DYNJ901829T:  UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25DDA191;  REF DYNJ901829T:  UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25BDB095;  REF DYNJ902030J:  UDI/DI 10195327391249 (EA) 40195327391240 (CS), Lot Number 25DBJ371;  REF DYNJ905274D:  UDI/DI 10195327393014 (EA) 40195327393015 (CS), Lot Number 25BBS130;  REF DYNJ905485J:  UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25FBJ689;  REF DYNJ905485J:  UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25EBP700;  REF DYNJ905485J:  UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25DBG283;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBJ430;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBC561;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBK650;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBE453;  REF DYNJ910634:  UDI/DI 10198459050398 (EA) 40198459050399 (CS), Lot Number 25CBS527;  REF DYNJ910927:  UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25FMC511;  REF DYNJ910927:  UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25CMJ281.. 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-1089-2026&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-1089-2026&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-1089-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1089-2026 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-1089-2026&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-1089-2026&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-1089-2026/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-1089-2026",
      "numberOfItems": 9,
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1089-2026",
            "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"
          }
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        {
          "@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 kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-12-16",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "REF CDS980754T:  UDI/DI 10198459121814 (EA) 40198459121815 (CS), Lot Number 25EMD795;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBR237;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBP591;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25DBM353;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25CBL184;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25BBL633;  REF CDS985344F:  UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25FBK918;  REF CDS985344F:  UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25CBJ496;  REF DYNJQ9041R:  UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25FBF371;  REF DYNJQ9041R:  UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25EBK493;  REF DYNJQ9041R:  UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25DBH895;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25DBC272;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBU642;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBJ298;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25BBU206;  REF DYNJ901281I:  UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25FBA261;  REF DYNJ901281I:  UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25CBN230;  REF DYNJ901829T:  UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25FDB398;  REF DYNJ901829T:  UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25DDA191;  REF DYNJ901829T:  UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25BDB095;  REF DYNJ902030J:  UDI/DI 10195327391249 (EA) 40195327391240 (CS), Lot Number 25DBJ371;  REF DYNJ905274D:  UDI/DI 10195327393014 (EA) 40195327393015 (CS), Lot Number 25BBS130;  REF DYNJ905485J:  UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25FBJ689;  REF DYNJ905485J:  UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25EBP700;  REF DYNJ905485J:  UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25DBG283;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBJ430;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBC561;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBK650;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBE453;  REF DYNJ910634:  UDI/DI 10198459050398 (EA) 40198459050399 (CS), Lot Number 25CBS527;  REF DYNJ910927:  UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25FMC511;  REF DYNJ910927:  UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25CMJ281.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}