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  "name": "Medline Convenience kits used for various procedures:  1) UTHET TYLER OB PACK, Model Number: DYNJ68673;   2) D AND C PACK, Model Number: DYNJ66290A;   3) D & C PACK-LF, Model Number: DYNJ24159C;   4) OB PACK, Model Number: DYNJ54484A;   5) PERI GYN-LF, Model Number: DYNJS3040;   6) D&C, Model Number: DYNJ900422F;   7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A;   8) D AND C PACK, Model Number: DYNJ66290A;   9) D&C PACK, Model Number: DYNJ47616B;   10) WMC D & C PACK-LF, Model Number: DYNJ50656B;   11) TRANSVAGINAL PACK, Model Number: DYNJ36599;   12) OB PACK, Model Number: DYNJ25915G;   13) PERI GYN-LF, Model Number: DYNJS3040;   14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A;   15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A;   16) OB PACK, Model Number: DYNJ64571;   17) WMC D & C PACK-LF, Model Number: DYNJ50656B;   18) D & C PACK-LF, Model Number: DYNJT2535G;   19) OB PACK, Model Number: DYNJ44522B;   20) OB PACK-LF, Model Number: DYNJ26121G;   21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C",
  "description": "FDA recall Z-1616-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits used for various procedures:  1) UTHET TYLER OB PACK, Model Number: DYNJ68673;   2) D AND C PACK, Model Number: DYNJ66290A;   3) D & C PACK-LF, Model Number: DYNJ24159C;   4) OB PACK, Model Number: DYNJ54484A;   5) PERI GYN-LF, Model Number: DYNJS3040;   6) D&C, Model Number: DYNJ900422F;   7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A;   8) D AND C PACK, Model Number: DYNJ66290A;   9) D&C PACK, Model Number: DYNJ47616B;   10) WMC D & C PACK-LF, Model Number: DYNJ50656B;   11) TRANSVAGINAL PACK, Model Number: DYNJ36599;   12) OB PACK, Model Number: DYNJ25915G;   13) PERI GYN-LF, Model Number: DYNJS3040;   14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A;   15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A;   16) OB PACK, Model Number: DYNJ64571;   17) WMC D & C PACK-LF, Model Number: DYNJ50656B;   18) D & C PACK-LF, Model Number: DYNJT2535G;   19) OB PACK, Model Number: DYNJ44522B;   20) OB PACK-LF, Model Number: DYNJ26121G;   21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits used for various procedures:  1) UTHET TYLER OB PACK, Model Number: DYNJ68673;   2) D AND C PACK, Model Number: DYNJ66290A;   3) D & C PACK-LF, Model Number: DYNJ24159C;   4) OB PACK, Model Number: DYNJ54484A;   5) PERI GYN-LF, Model Number: DYNJS3040;   6) D&C, Model Number: DYNJ900422F;   7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A;   8) D AND C PACK, Model Number: DYNJ66290A;   9) D&C PACK, Model Number: DYNJ47616B;   10) WMC D & C PACK-LF, Model Number: DYNJ50656B;   11) TRANSVAGINAL PACK, Model Number: DYNJ36599;   12) OB PACK, Model Number: DYNJ25915G;   13) PERI GYN-LF, Model Number: DYNJS3040;   14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A;   15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A;   16) OB PACK, Model Number: DYNJ64571;   17) WMC D & C PACK-LF, Model Number: DYNJ50656B;   18) D & C PACK-LF, Model Number: DYNJT2535G;   19) OB PACK, Model Number: DYNJ44522B;   20) OB PACK-LF, Model Number: DYNJ26121G;   21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C",
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      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1616-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1616-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits used for various procedures:  1) UTHET TYLER OB PACK, Model Number: DYNJ68673;   2) D AND C PACK, Model Number: DYNJ66290A;   3) D & C PACK-LF, Model Number: DYNJ24159C;   4) OB PACK, Model Number: DYNJ54484A;   5) PERI GYN-LF, Model Number: DYNJS3040;   6) D&C, Model Number: DYNJ900422F;   7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A;   8) D AND C PACK, Model Number: DYNJ66290A;   9) D&C PACK, Model Number: DYNJ47616B;   10) WMC D & C PACK-LF, Model Number: DYNJ50656B;   11) TRANSVAGINAL PACK, Model Number: DYNJ36599;   12) OB PACK, Model Number: DYNJ25915G;   13) PERI GYN-LF, Model Number: DYNJS3040;   14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A;   15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A;   16) OB PACK, Model Number: DYNJ64571;   17) WMC D & C PACK-LF, Model Number: DYNJ50656B;   18) D & C PACK-LF, Model Number: DYNJT2535G;   19) OB PACK, Model Number: DYNJ44522B;   20) OB PACK-LF, Model Number: DYNJ26121G;   21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C",
      "text": "The FDA logged enforcement record Z-1616-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits used for various procedures:  1) UTHET TYLER OB PACK, Model Number: DYNJ68673;   2) D AND C PACK, Model Number: DYNJ66290A;   3) D & C PACK-LF, Model Number: DYNJ24159C;   4) OB PACK, Model Number: DYNJ54484A;   5) PERI GYN-LF, Model Number: DYNJS3040;   6) D&C, Model Number: DYNJ900422F;   7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A;   8) D AND C PACK, Model Number: DYNJ66290A;   9) D&C PACK, Model Number: DYNJ47616B;   10) WMC D & C PACK-LF, Model Number: DYNJ50656B;   11) TRANSVAGINAL PACK, Model Number: DYNJ36599;   12) OB PACK, Model Number: DYNJ25915G;   13) PERI GYN-LF, Model Number: DYNJS3040;   14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A;   15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A;   16) OB PACK, Model Number: DYNJ64571;   17) WMC D & C PACK-LF, Model Number: DYNJ50656B;   18) D & C PACK-LF, Model Number: DYNJT2535G;   19) OB PACK, Model Number: DYNJ44522B;   20) OB PACK-LF, Model Number: DYNJ26121G;   21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C;   24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C — reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-03. Affected lots/codes: 1) DYNJ68673, UDI-DI: 10193489839951(each), 40193489839952(case), Lot Number: 24IBG873; 2) DYNJ66290A, UDI-DI: 10193489461428(each), 40193489461429(case), Lot Number: 24IBG957; 3) DYNJ24159C, UDI-DI: 10198459032394(each), 40198459032395(case), Lot Number: 24IBL229; 4) DYNJ54484A, UDI-DI: 10193489813074(each), 40193489813075(case), Lot Number: 24IBS805; 5) DYNJS3040, UDI-DI: 10884389602225(each), 40884389602226(case), Lot Number: 24JBL655; 6) DYNJ900422F, UDI-DI: 10195327658373(each), 40195327658374(case), Lot Number: 24JBM234; 7) CDS985201A, UDI-DI: 10889942942312(each), 40889942942313(case), Lot Number: 24JBN479; 8) DYNJ66290A, UDI-DI: 10193489461428(each), 40193489461429(case), Lot Number: 24JBN645; 9) DYNJ47616B, UDI-DI: 10193489731040(each), 40193489731041(case), Lot Number: 24JBT461; 10) DYNJ50656B, UDI-DI: 10195327306410(each), 40195327306411(case), Lot Number: 24JBT906; 11) DYNJ36599, UDI-DI: 10884389554142(each), 40884389554143(case), Lot Number: 24JBW173; 12) DYNJ25915G, UDI-DI: 10193489718942(each), 40193489718943(case), Lot Number: 24JBW203; 13) DYNJS3040, UDI-DI: 10884389602225(each), 40884389602226(case), Lot Number: 24JBW545; 14) DYNJ0989660A, UDI-DI: 10889942136131(each), 40889942136132(case), Lot Number: 24JBX677; 15) DYNJ64226A, UDI-DI: 10195327135430(each), 40195327135431(case), Lot Number: 24KBC728; 16) DYNJ64571, UDI-DI: 10193489208986(each), 40193489208987(case), Lot Number: 24KBD692; 17) DYNJ50656B, UDI-DI: 10195327306410(each), 40195327306411(case), Lot Number: 24KBF096; 18) DYNJT2535G, UDI-DI: 10195327548506(each), 40195327548507(case), Lot Number: 24KBG398; 19) DYNJ44522B, UDI-DI: 10193489691511(each), 40193489691512(case), Lot Number: 24KBG967; 20) DYNJ26121G, UDI-DI: 10889942225248(each), 40889942225249(case), Lot Number: 24KBG978; 21) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24KBS436; 22) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24LBF208; 23) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24LBR809; 24) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 25ABF622. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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        "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-1616-2025&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-1616-2025&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-1616-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1616-2025 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-1616-2025&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-1616-2025&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-1616-2025/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
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      "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."
    }
  ],
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      "name": "FDA recall details — Z-1616-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1616-2025",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
          "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"
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        {
          "@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": "There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-03-03",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) DYNJ68673, UDI-DI: 10193489839951(each), 40193489839952(case), Lot Number: 24IBG873; 2) DYNJ66290A, UDI-DI: 10193489461428(each), 40193489461429(case), Lot Number: 24IBG957; 3) DYNJ24159C, UDI-DI: 10198459032394(each), 40198459032395(case), Lot Number: 24IBL229; 4) DYNJ54484A, UDI-DI: 10193489813074(each), 40193489813075(case), Lot Number: 24IBS805; 5) DYNJS3040, UDI-DI: 10884389602225(each), 40884389602226(case), Lot Number: 24JBL655; 6) DYNJ900422F, UDI-DI: 10195327658373(each), 40195327658374(case), Lot Number: 24JBM234; 7) CDS985201A, UDI-DI: 10889942942312(each), 40889942942313(case), Lot Number: 24JBN479; 8) DYNJ66290A, UDI-DI: 10193489461428(each), 40193489461429(case), Lot Number: 24JBN645; 9) DYNJ47616B, UDI-DI: 10193489731040(each), 40193489731041(case), Lot Number: 24JBT461; 10) DYNJ50656B, UDI-DI: 10195327306410(each), 40195327306411(case), Lot Number: 24JBT906; 11) DYNJ36599, UDI-DI: 10884389554142(each), 40884389554143(case), Lot Number: 24JBW173; 12) DYNJ25915G, UDI-DI: 10193489718942(each), 40193489718943(case), Lot Number: 24JBW203; 13) DYNJS3040, UDI-DI: 10884389602225(each), 40884389602226(case), Lot Number: 24JBW545; 14) DYNJ0989660A, UDI-DI: 10889942136131(each), 40889942136132(case), Lot Number: 24JBX677; 15) DYNJ64226A, UDI-DI: 10195327135430(each), 40195327135431(case), Lot Number: 24KBC728; 16) DYNJ64571, UDI-DI: 10193489208986(each), 40193489208987(case), Lot Number: 24KBD692; 17) DYNJ50656B, UDI-DI: 10195327306410(each), 40195327306411(case), Lot Number: 24KBF096; 18) DYNJT2535G, UDI-DI: 10195327548506(each), 40195327548507(case), Lot Number: 24KBG398; 19) DYNJ44522B, UDI-DI: 10193489691511(each), 40193489691512(case), Lot Number: 24KBG967; 20) DYNJ26121G, UDI-DI: 10889942225248(each), 40889942225249(case), Lot Number: 24KBG978; 21) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24KBS436; 22) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24LBF208; 23) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24LBR809; 24) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 25ABF622",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}