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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1191-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical procedure convenience kits labeled as:    1)\tSMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P;   2)\tDEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K;   3)\tLAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J;   4)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N;   5)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O;   6)\tBWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B;   7)\tMINOR SET UP PACK, Kit SKU DYNJ43272K;   8)\tPK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C;   9)\tGV LAP CHOLE PACK, Kit SKU DYNJ46939Q;   10)\tLAP CHOLE PACK, Kit SKU DYNJ49688C;   11)\tGENERAL ROBOTIC LAP, Kit SKU DYNJ51347N;   12)\tLAP CHOLE PACK, Kit SKU DYNJ54081F;   13)\tPEDIATRIC MOSES, Kit SKU DYNJ58864B;   14)\tLAPAROTOMY PACK, Kit SKU DYNJ59313B;   15)\tCRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F;   16)\tLAP GASTRIC PACK, Kit SKU DYNJ62065A;   17)\tMINOR PACK, Kit SKU DYNJ64174A;   18)\tGENERAL SURGERY PACK, Kit SKU DYNJ64258I;   19)\tGENERAL LAP SHARED-LF, Kit SKU DYNJ64786D;   20)\tCHOLE PACK, Kit SKU DYNJ67686B;   21)\tGEN SURG MINOR PACK, Kit SKU DYNJ69142F;   22)\tLAP CHOLE PACK, Kit SKU DYNJ81695B;   23)\tGENERAL LAPAROSCOPY, Kit SKU DYNJ900901K;   24)\tGEN MINOR, Kit SKU DYNJ900906L;   25)\tROBOTIC GENERAL, Kit SKU DYNJ906861D;   26)\tRMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C;   27)\tLAP CHOLE LMC CDS, Kit SKU DYNJ911116A;   28)\tMINOR GENERAL PACK, Kit SKU DYNJT3884;   29)\tGENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504;   30)\tMINOR SURGERY PACK-LF, Kit SKU PHS109062D.",
  "description": "FDA recall Z-1191-2026 — Medline Industries, LP is recalling Medline medical procedure convenience kits labeled as:    1)\tSMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P;   2)\tDEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K;   3)\tLAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J;   4)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N;   5)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O;   6)\tBWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B;   7)\tMINOR SET UP PACK, Kit SKU DYNJ43272K;   8)\tPK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C;   9)\tGV LAP CHOLE PACK, Kit SKU DYNJ46939Q;   10)\tLAP CHOLE PACK, Kit SKU DYNJ49688C;   11)\tGENERAL ROBOTIC LAP, Kit SKU DYNJ51347N;   12)\tLAP CHOLE PACK, Kit SKU DYNJ54081F;   13)\tPEDIATRIC MOSES, Kit SKU DYNJ58864B;   14)\tLAPAROTOMY PACK, Kit SKU DYNJ59313B;   15)\tCRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F;   16)\tLAP GASTRIC PACK, Kit SKU DYNJ62065A;   17)\tMINOR PACK, Kit SKU DYNJ64174A;   18)\tGENERAL SURGERY PACK, Kit SKU DYNJ64258I;   19)\tGENERAL LAP SHARED-LF, Kit SKU DYNJ64786D;   20)\tCHOLE PACK, Kit SKU DYNJ67686B;   21)\tGEN SURG MINOR PACK, Kit SKU DYNJ69142F;   22)\tLAP CHOLE PACK, Kit SKU DYNJ81695B;   23)\tGENERAL LAPAROSCOPY, Kit SKU DYNJ900901K;   24)\tGEN MINOR, Kit SKU DYNJ900906L;   25)\tROBOTIC GENERAL, Kit SKU DYNJ906861D;   26)\tRMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C;   27)\tLAP CHOLE LMC CDS, Kit SKU DYNJ911116A;   28)\tMINOR GENERAL PACK, Kit SKU DYNJT3884;   29)\tGENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504;   30)\tMINOR SURGERY PACK-LF, Kit SKU PHS109062D. (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 medical procedure convenience kits labeled as:    1)\tSMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P;   2)\tDEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K;   3)\tLAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J;   4)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N;   5)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O;   6)\tBWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B;   7)\tMINOR SET UP PACK, Kit SKU DYNJ43272K;   8)\tPK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C;   9)\tGV LAP CHOLE PACK, Kit SKU DYNJ46939Q;   10)\tLAP CHOLE PACK, Kit SKU DYNJ49688C;   11)\tGENERAL ROBOTIC LAP, Kit SKU DYNJ51347N;   12)\tLAP CHOLE PACK, Kit SKU DYNJ54081F;   13)\tPEDIATRIC MOSES, Kit SKU DYNJ58864B;   14)\tLAPAROTOMY PACK, Kit SKU DYNJ59313B;   15)\tCRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F;   16)\tLAP GASTRIC PACK, Kit SKU DYNJ62065A;   17)\tMINOR PACK, Kit SKU DYNJ64174A;   18)\tGENERAL SURGERY PACK, Kit SKU DYNJ64258I;   19)\tGENERAL LAP SHARED-LF, Kit SKU DYNJ64786D;   20)\tCHOLE PACK, Kit SKU DYNJ67686B;   21)\tGEN SURG MINOR PACK, Kit SKU DYNJ69142F;   22)\tLAP CHOLE PACK, Kit SKU DYNJ81695B;   23)\tGENERAL LAPAROSCOPY, Kit SKU DYNJ900901K;   24)\tGEN MINOR, Kit SKU DYNJ900906L;   25)\tROBOTIC GENERAL, Kit SKU DYNJ906861D;   26)\tRMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C;   27)\tLAP CHOLE LMC CDS, Kit SKU DYNJ911116A;   28)\tMINOR GENERAL PACK, Kit SKU DYNJT3884;   29)\tGENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504;   30)\tMINOR SURGERY PACK-LF, Kit SKU PHS109062D.",
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      "name": "Medline Industries, LP"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1191-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1191-2026: Medline Industries, LP is recalling Medline medical procedure convenience kits labeled as:    1)\tSMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P;   2)\tDEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K;   3)\tLAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J;   4)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N;   5)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O;   6)\tBWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B;   7)\tMINOR SET UP PACK, Kit SKU DYNJ43272K;   8)\tPK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C;   9)\tGV LAP CHOLE PACK, Kit SKU DYNJ46939Q;   10)\tLAP CHOLE PACK, Kit SKU DYNJ49688C;   11)\tGENERAL ROBOTIC LAP, Kit SKU DYNJ51347N;   12)\tLAP CHOLE PACK, Kit SKU DYNJ54081F;   13)\tPEDIATRIC MOSES, Kit SKU DYNJ58864B;   14)\tLAPAROTOMY PACK, Kit SKU DYNJ59313B;   15)\tCRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F;   16)\tLAP GASTRIC PACK, Kit SKU DYNJ62065A;   17)\tMINOR PACK, Kit SKU DYNJ64174A;   18)\tGENERAL SURGERY PACK, Kit SKU DYNJ64258I;   19)\tGENERAL LAP SHARED-LF, Kit SKU DYNJ64786D;   20)\tCHOLE PACK, Kit SKU DYNJ67686B;   21)\tGEN SURG MINOR PACK, Kit SKU DYNJ69142F;   22)\tLAP CHOLE PACK, Kit SKU DYNJ81695B;   23)\tGENERAL LAPAROSCOPY, Kit SKU DYNJ900901K;   24)\tGEN MINOR, Kit SKU DYNJ900906L;   25)\tROBOTIC GENERAL, Kit SKU DYNJ906861D;   26)\tRMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C;   27)\tLAP CHOLE LMC CDS, Kit SKU DYNJ911116A;   28)\tMINOR GENERAL PACK, Kit SKU DYNJT3884;   29)\tGENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504;   30)\tMINOR SURGERY PACK-LF, Kit SKU PHS109062D.",
      "text": "The FDA logged enforcement record Z-1191-2026: Medline Industries, LP is voluntarily recalling Medline medical procedure convenience kits labeled as:    1)\tSMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P;   2)\tDEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K;   3)\tLAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J;   4)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N;   5)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O;   6)\tBWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B;   7)\tMINOR SET UP PACK, Kit SKU DYNJ43272K;   8)\tPK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C;   9)\tGV LAP CHOLE PACK, Kit SKU DYNJ46939Q;   10)\tLAP CHOLE PACK, Kit SKU DYNJ49688C;   11)\tGENERAL ROBOTIC LAP, Kit SKU DYNJ51347N;   12)\tLAP CHOLE PACK, Kit SKU DYNJ54081F;   13)\tPEDIATRIC MOSES, Kit SKU DYNJ58864B;   14)\tLAPAROTOMY PACK, Kit SKU DYNJ59313B;   15)\tCRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F;   16)\tLAP GASTRIC PACK, Kit SKU DYNJ62065A;   17)\tMINOR PACK, Kit SKU DYNJ64174A;   18)\tGENERAL SURGERY PACK, Kit SKU DYNJ64258I;   19)\tGENERAL LAP SHARED-LF, Kit SKU DYNJ64786D;   20)\tCHOLE PACK, Kit SKU DYNJ67686B;   21)\tGEN SURG MINOR PACK, Kit SKU DYNJ69142F;   22)\tLAP CHOLE PACK, Kit SKU DYNJ81695B;   23)\tGENERAL LAPAROSCOPY, Kit SKU DYNJ900901K;   24)\tGEN MINOR, Kit SKU DYNJ900906L;   25)\tROBOTIC GENERAL, Kit SKU DYNJ906861D;   26)\tRMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C;   27)\tLAP CHOLE LMC CDS, Kit SKU DYNJ911116A;   28)\tMINOR GENERAL PACK, Kit SKU DYNJT3884;   29)\tGENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504;   30)\tMINOR SURGERY PACK-LF, Kit SKU PHS109062D. — reason: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-12. Affected lots/codes: Medline Kit SKU DYNJ19974P:  UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB830;  Medline Kit SKU DYNJ19974P:  UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB831;  Medline Kit SKU DYNJ20027K:  UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMG395;  Medline Kit SKU DYNJ20027K:  UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMH132;  Medline Kit SKU DYNJ20468J:  UDI/DI 10195327024338 (EA) 40195327024339 (CS), Lot Number 25KMF540;  Medline Kit SKU DYNJ25763N:  UDI/DI 10198459138218 (EA) 40198459138219 (CS), Lot Number 25KMH134;  Medline Kit SKU DYNJ25763O:  UDI/DI 10198459603655 (EA) 40198459603656 (CS), Lot Number 25KMI209;  Medline Kit SKU DYNJ32836B:  UDI/DI 10195327037369 (EA) 40195327037360 (CS), Lot Number 25KBF167;  Medline Kit SKU DYNJ43272K:  UDI/DI 10198459257131 (EA) 40198459257132 (CS), Lot Number 25KME892;  Medline Kit SKU DYNJ43976C:  UDI/DI 10193489806694 (EA) 40193489806695 (CS), Lot Number 25KMG962;  Medline Kit SKU DYNJ46939Q:  UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25JDA437;  Medline Kit SKU DYNJ46939Q:  UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25LDA059;  Medline Kit SKU DYNJ49688C:  UDI/DI 10198459155017 (EA) 40198459155018 (CS), Lot Number 25KMG180;  Medline Kit SKU DYNJ51347N:  UDI/DI 10198459386428 (EA) 40198459386429 (CS), Lot Number 25JBW506;  Medline Kit SKU DYNJ54081F:  UDI/DI 10198459172410 (EA) 40198459172411 (CS), Lot Number 25KMB295;  Medline Kit SKU DYNJ58864B:  UDI/DI 10198459346965 (EA) 40198459346966 (CS), Lot Number 25JBW678;  Medline Kit SKU DYNJ59313B:  UDI/DI 10195327248338 (EA) 40195327248339 (CS), Lot Number 25JMJ736;  Medline Kit SKU DYNJ61095F:  UDI/DI 10198459228568 (EA) 40198459228569 (CS), Lot Number 25KMC402;  Medline Kit SKU DYNJ62065A:  UDI/DI 10193489273472 (EA) 40193489273473 (CS), Lot Number 25KMI773;  Medline Kit SKU DYNJ64174A:  UDI/DI 10198459076367 (EA) 40198459076368 (CS), Lot Number 25LMB281;  Medline Kit SKU DYNJ64258I:  UDI/DI 10198459031564 (EA) 40198459031565 (CS), Lot Number 25KMJ665;  Medline Kit SKU DYNJ64786D:  UDI/DI 10198459328671 (EA) 40198459328672 (CS), Lot Number 25JMJ978;  Medline Kit SKU DYNJ67686B:  UDI/DI 10198459383120 (EA) 40198459383121 (CS), Lot Number 25KMH683;  Medline Kit SKU DYNJ69142F:  UDI/DI 10198459478499 (EA) 40198459478490 (CS), Lot Number 25KMH891;  Medline Kit SKU DYNJ81695B:  UDI/DI 10198459023453 (EA) 40198459023454 (CS), Lot Number 25KMB850;  Medline Kit SKU DYNJ900901K:  UDI/DI 10198459272493 (EA) 40198459272494 (CS), Lot Number 25KBP907;  Medline Kit SKU DYNJ900906L:  UDI/DI 10198459408526 (EA) 40198459408527 (CS), Lot Number 25LMA386;  Medline Kit SKU DYNJ906861D:  UDI/DI 10198459293702 (EA) 40198459293703 (CS), Lot Number 25LMA703;  Medline Kit SKU DYNJ907087C:  UDI/DI 10198459201301 (EA) 40198459201302 (CS), Lot Number 25KMJ480;  Medline Kit SKU DYNJ911116A:  UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMH214;  Medline Kit SKU DYNJ911116A:  UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMJ766;  Medline Kit SKU DYNJT3884:  UDI/DI 10198459366840 (EA) 40198459366841 (CS), Lot Number 25JBX326;  Medline Kit SKU DYNJT4504:  UDI/DI 10198459456701 (EA) 40198459456702 (CS), Lot Number 25KMF188;  Medline Kit SKU PHS109062D:  UDI/DI 10889942716548 (EA) 40889942716549 (CS), Lot Number 25KMD005.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
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        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1191-2026&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-1191-2026&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-1191-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1191-2026 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-1191-2026&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-1191-2026&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-1191-2026/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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      "name": "FDA recall details — Z-1191-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1191-2026",
            "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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          "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"
          }
        },
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-12-12",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Medline Kit SKU DYNJ19974P:  UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB830;  Medline Kit SKU DYNJ19974P:  UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB831;  Medline Kit SKU DYNJ20027K:  UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMG395;  Medline Kit SKU DYNJ20027K:  UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMH132;  Medline Kit SKU DYNJ20468J:  UDI/DI 10195327024338 (EA) 40195327024339 (CS), Lot Number 25KMF540;  Medline Kit SKU DYNJ25763N:  UDI/DI 10198459138218 (EA) 40198459138219 (CS), Lot Number 25KMH134;  Medline Kit SKU DYNJ25763O:  UDI/DI 10198459603655 (EA) 40198459603656 (CS), Lot Number 25KMI209;  Medline Kit SKU DYNJ32836B:  UDI/DI 10195327037369 (EA) 40195327037360 (CS), Lot Number 25KBF167;  Medline Kit SKU DYNJ43272K:  UDI/DI 10198459257131 (EA) 40198459257132 (CS), Lot Number 25KME892;  Medline Kit SKU DYNJ43976C:  UDI/DI 10193489806694 (EA) 40193489806695 (CS), Lot Number 25KMG962;  Medline Kit SKU DYNJ46939Q:  UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25JDA437;  Medline Kit SKU DYNJ46939Q:  UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25LDA059;  Medline Kit SKU DYNJ49688C:  UDI/DI 10198459155017 (EA) 40198459155018 (CS), Lot Number 25KMG180;  Medline Kit SKU DYNJ51347N:  UDI/DI 10198459386428 (EA) 40198459386429 (CS), Lot Number 25JBW506;  Medline Kit SKU DYNJ54081F:  UDI/DI 10198459172410 (EA) 40198459172411 (CS), Lot Number 25KMB295;  Medline Kit SKU DYNJ58864B:  UDI/DI 10198459346965 (EA) 40198459346966 (CS), Lot Number 25JBW678;  Medline Kit SKU DYNJ59313B:  UDI/DI 10195327248338 (EA) 40195327248339 (CS), Lot Number 25JMJ736;  Medline Kit SKU DYNJ61095F:  UDI/DI 10198459228568 (EA) 40198459228569 (CS), Lot Number 25KMC402;  Medline Kit SKU DYNJ62065A:  UDI/DI 10193489273472 (EA) 40193489273473 (CS), Lot Number 25KMI773;  Medline Kit SKU DYNJ64174A:  UDI/DI 10198459076367 (EA) 40198459076368 (CS), Lot Number 25LMB281;  Medline Kit SKU DYNJ64258I:  UDI/DI 10198459031564 (EA) 40198459031565 (CS), Lot Number 25KMJ665;  Medline Kit SKU DYNJ64786D:  UDI/DI 10198459328671 (EA) 40198459328672 (CS), Lot Number 25JMJ978;  Medline Kit SKU DYNJ67686B:  UDI/DI 10198459383120 (EA) 40198459383121 (CS), Lot Number 25KMH683;  Medline Kit SKU DYNJ69142F:  UDI/DI 10198459478499 (EA) 40198459478490 (CS), Lot Number 25KMH891;  Medline Kit SKU DYNJ81695B:  UDI/DI 10198459023453 (EA) 40198459023454 (CS), Lot Number 25KMB850;  Medline Kit SKU DYNJ900901K:  UDI/DI 10198459272493 (EA) 40198459272494 (CS), Lot Number 25KBP907;  Medline Kit SKU DYNJ900906L:  UDI/DI 10198459408526 (EA) 40198459408527 (CS), Lot Number 25LMA386;  Medline Kit SKU DYNJ906861D:  UDI/DI 10198459293702 (EA) 40198459293703 (CS), Lot Number 25LMA703;  Medline Kit SKU DYNJ907087C:  UDI/DI 10198459201301 (EA) 40198459201302 (CS), Lot Number 25KMJ480;  Medline Kit SKU DYNJ911116A:  UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMH214;  Medline Kit SKU DYNJ911116A:  UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMJ766;  Medline Kit SKU DYNJT3884:  UDI/DI 10198459366840 (EA) 40198459366841 (CS), Lot Number 25JBX326;  Medline Kit SKU DYNJT4504:  UDI/DI 10198459456701 (EA) 40198459456702 (CS), Lot Number 25KMF188;  Medline Kit SKU PHS109062D:  UDI/DI 10889942716548 (EA) 40889942716549 (CS), Lot Number 25KMD005.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}