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  "name": "Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;    Product description/Product numbers:    ADULT 120 EXPANDABLE W/MASK  DYNJAA10591;  ANES CIRC 120IN EXP-LF  DYNJAA6555G;  ANES CIRCUIT ADULT 120\"-LF  DYNJAA10817;  ANESTHESIA 120\" ADLT-LF  DYNJAA10775;  ANESTHESIA CIRC ADULT 120-LF  DYNJAA10601;  ANESTHESIA CIRCUIT - LF  DYNJAA10261B;  ANESTHESIA CIRCUIT 120EXP-LF  DYNJAA10741A;  ANESTHESIA CIRCUIT ADULT-LF  DYNJAA0380A  DYNJAA10641  DYNJAA10706B  DYNJAA10851  DYNJAA10922B  DYNJAA10971A  DYNJAA11030A  DYNJAA11087  DYNJAA11126;  ANESTHESIA CIRCUIT-LF  DYNJAA0309A  DYNJAA0368A  DYNJAA10368A  DYNJAA10392  DYNJAA10430A  DYNJAA10547A  DYNJAA10639A  DYNJAA10656A  DYNJAA10685A  DYNJAA10685B;  CIRC 120\" EXP 1 BV HMEF 3L GSL  DYNJAA10920;  EXPANDABLE CIRCUIT-LF  DYNJAA11095;  NM ANESTHESIA TURNOVER KIT  DYNJAA0433;  PROV HEALTH HEPA CIRC #2-LF  DYNJAA0360;  SPTMPX01IA CIRCUIT ADULT-LF  DYNJAA10973A;",
  "description": "FDA recall Z-0442-2026 — Medline Industries, LP is recalling Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;    Product description/Product numbers:    ADULT 120 EXPANDABLE W/MASK  DYNJAA10591;  ANES CIRC 120IN EXP-LF  DYNJAA6555G;  ANES CIRCUIT ADULT 120\"-LF  DYNJAA10817;  ANESTHESIA 120\" ADLT-LF  DYNJAA10775;  ANESTHESIA CIRC ADULT 120-LF  DYNJAA10601;  ANESTHESIA CIRCUIT - LF  DYNJAA10261B;  ANESTHESIA CIRCUIT 120EXP-LF  DYNJAA10741A;  ANESTHESIA CIRCUIT ADULT-LF  DYNJAA0380A  DYNJAA10641  DYNJAA10706B  DYNJAA10851  DYNJAA10922B  DYNJAA10971A  DYNJAA11030A  DYNJAA11087  DYNJAA11126;  ANESTHESIA CIRCUIT-LF  DYNJAA0309A  DYNJAA0368A  DYNJAA10368A  DYNJAA10392  DYNJAA10430A  DYNJAA10547A  DYNJAA10639A  DYNJAA10656A  DYNJAA10685A  DYNJAA10685B;  CIRC 120\" EXP 1 BV HMEF 3L GSL  DYNJAA10920;  EXPANDABLE CIRCUIT-LF  DYNJAA11095;  NM ANESTHESIA TURNOVER KIT  DYNJAA0433;  PROV HEALTH HEPA CIRC #2-LF  DYNJAA0360;  SPTMPX01IA CIRCUIT ADULT-LF  DYNJAA10973A; (Devices, Class I). 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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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;    Product description/Product numbers:    ADULT 120 EXPANDABLE W/MASK  DYNJAA10591;  ANES CIRC 120IN EXP-LF  DYNJAA6555G;  ANES CIRCUIT ADULT 120\"-LF  DYNJAA10817;  ANESTHESIA 120\" ADLT-LF  DYNJAA10775;  ANESTHESIA CIRC ADULT 120-LF  DYNJAA10601;  ANESTHESIA CIRCUIT - LF  DYNJAA10261B;  ANESTHESIA CIRCUIT 120EXP-LF  DYNJAA10741A;  ANESTHESIA CIRCUIT ADULT-LF  DYNJAA0380A  DYNJAA10641  DYNJAA10706B  DYNJAA10851  DYNJAA10922B  DYNJAA10971A  DYNJAA11030A  DYNJAA11087  DYNJAA11126;  ANESTHESIA CIRCUIT-LF  DYNJAA0309A  DYNJAA0368A  DYNJAA10368A  DYNJAA10392  DYNJAA10430A  DYNJAA10547A  DYNJAA10639A  DYNJAA10656A  DYNJAA10685A  DYNJAA10685B;  CIRC 120\" EXP 1 BV HMEF 3L GSL  DYNJAA10920;  EXPANDABLE CIRCUIT-LF  DYNJAA11095;  NM ANESTHESIA TURNOVER KIT  DYNJAA0433;  PROV HEALTH HEPA CIRC #2-LF  DYNJAA0360;  SPTMPX01IA CIRCUIT ADULT-LF  DYNJAA10973A;",
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      "name": "Medline Industries, LP"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0442-2026/enforcement-record",
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      "name": "FDA recall Z-0442-2026: Medline Industries, LP is recalling Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;    Product description/Product numbers:    ADULT 120 EXPANDABLE W/MASK  DYNJAA10591;  ANES CIRC 120IN EXP-LF  DYNJAA6555G;  ANES CIRCUIT ADULT 120\"-LF  DYNJAA10817;  ANESTHESIA 120\" ADLT-LF  DYNJAA10775;  ANESTHESIA CIRC ADULT 120-LF  DYNJAA10601;  ANESTHESIA CIRCUIT - LF  DYNJAA10261B;  ANESTHESIA CIRCUIT 120EXP-LF  DYNJAA10741A;  ANESTHESIA CIRCUIT ADULT-LF  DYNJAA0380A  DYNJAA10641  DYNJAA10706B  DYNJAA10851  DYNJAA10922B  DYNJAA10971A  DYNJAA11030A  DYNJAA11087  DYNJAA11126;  ANESTHESIA CIRCUIT-LF  DYNJAA0309A  DYNJAA0368A  DYNJAA10368A  DYNJAA10392  DYNJAA10430A  DYNJAA10547A  DYNJAA10639A  DYNJAA10656A  DYNJAA10685A  DYNJAA10685B;  CIRC 120\" EXP 1 BV HMEF 3L GSL  DYNJAA10920;  EXPANDABLE CIRCUIT-LF  DYNJAA11095;  NM ANESTHESIA TURNOVER KIT  DYNJAA0433;  PROV HEALTH HEPA CIRC #2-LF  DYNJAA0360;  SPTMPX01IA CIRCUIT ADULT-LF  DYNJAA10973A;",
      "text": "The FDA logged enforcement record Z-0442-2026: Medline Industries, LP is voluntarily recalling Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;    Product description/Product numbers:    ADULT 120 EXPANDABLE W/MASK  DYNJAA10591;  ANES CIRC 120IN EXP-LF  DYNJAA6555G;  ANES CIRCUIT ADULT 120\"-LF  DYNJAA10817;  ANESTHESIA 120\" ADLT-LF  DYNJAA10775;  ANESTHESIA CIRC ADULT 120-LF  DYNJAA10601;  ANESTHESIA CIRCUIT - LF  DYNJAA10261B;  ANESTHESIA CIRCUIT 120EXP-LF  DYNJAA10741A;  ANESTHESIA CIRCUIT ADULT-LF  DYNJAA0380A  DYNJAA10641  DYNJAA10706B  DYNJAA10851  DYNJAA10922B  DYNJAA10971A  DYNJAA11030A  DYNJAA11087  DYNJAA11126;  ANESTHESIA CIRCUIT-LF  DYNJAA0309A  DYNJAA0368A  DYNJAA10368A  DYNJAA10392  DYNJAA10430A  DYNJAA10547A  DYNJAA10639A  DYNJAA10656A  DYNJAA10685A  DYNJAA10685B;  CIRC 120\" EXP 1 BV HMEF 3L GSL  DYNJAA10920;  EXPANDABLE CIRCUIT-LF  DYNJAA11095;  NM ANESTHESIA TURNOVER KIT  DYNJAA0433;  PROV HEALTH HEPA CIRC #2-LF  DYNJAA0360;  SPTMPX01IA CIRCUIT ADULT-LF  DYNJAA10973A; — reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120\" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-10. Affected lots/codes: DYNJAA0309A UDI-DI 40193489400268 (case), 10193489400267 (ea) Lots 25EBU353 25GBI473;  DYNJAA0360 UDI DI 40193489419000 (case), 10193489419009 (ea) Lots 25EBU304 25GBQ732;  DYNJAA0368A UDI-DI 40195327092550 (case), 10195327092559 (ea) Lots 25GBH582;  DYNJAA0380A UDI-DI 40195327478286 (case), 10195327478285 (ea) Lots 25FBB950 25FBT875 25GBX623;  DYNJAA0433 UDI-DI 40198459320706 (case), 10198459320705 (ea) Lots 25EBH621 25EBQ391;  DYNJAA10261B UDI- DI 40193489430784 (case), 10193489430783 (ea) Lots 25FBJ760;  DYNJAA10368A UDI-DI 40198459320720 (case), 10198459320729 (ea) Lots 25GBY374 25IBK072;  DYNJAA10392 UDI-DI 40888277962201 (case), 10888277962200 (ea) Lots 25FBN032;  DYNJAA10430A UDI-DI 40193489832052 (case), 10193489832051 (ea) Lots 25FBW335 25IBH048;  DYNJAA10547A UDI-DI 40193489603188 (case), 10193489603187 (ea) 25FBT853;  DYNJAA10591 UDI-DI 40889942632535 (case), 10889942632534 (ea) Lots 25FBD876 25FBD877 25GBJ254 25GBJ256;  DYNJAA10601 UDI-DI 40889942655435 (case), 10889942655434 (ea) Lots 25FBN184 25HBM893;  DYNJAA10639A UDI-DI 40888277761958 (case), 10888277761957 (ea) Lots 25FBN043;  DYNJAA10641 UDI-DI 40889942841227 (case), 10889942841226 (ea) Lots 25EBK360;  DYNJAA10656A UDI-DI 40193489455527 (case), 10193489455526 (ea) Lots 25FBN055;  DYNJAA10685A UDI-DI 40195327279142 (case), 10195327279141 (ea) Lots 25EBJ456;  DYNJAA10685B UDI-DI 40198459372293 (case), 10198459372292 (ea) Lots 25FBL121 25FBT898 25FBT899;  DYNJAA10706B UDI-DI 40193489485982 (case), 10193489485981 (ea) Lots 25FBH921 25GBK879 25GBN124 25GBN125;  DYNJAA10741A UDI-DI 40193489250573 (case), 10193489250572 (ea) Lots 25EBK364 25FBQ326 25HBA472;  DYNJAA10775 UDI-DI 40193489348102 (case), 10193489348101 (ea) Lots 25GBY311 25IBD803;  DYNJAA10817 UDI-DI 40193489365338 (case), 10193489365337 (ea) Lots 25GBO619;  DYNJAA10851 UDI-DI 40193489429467 (case), 10193489429466 (ea) Lots 25GBE789 25IBL075;  DYNJAA10920 UDI-DI 40193489463386 (case), 10193489463385 (ea) Lots 25FBT844 25GBP694;  DYNJAA10922B UDI-DI 40198459301880 (case), 10198459301889 (ea) Lots 25FBQ442 25GBO675;  DYNJAA10971A UDI-DI 40195327298167 (case), 10195327298166 (ea) Lots 25GBA751;  DYNJAA10973A UDI-DI 40195327372423 (case), 10195327372422 (ea) Lots 25FBQ349;  DYNJAA11030A UDI-DI 40195327341030 (case), 10195327341039 (ea) Lots 25FBQ346;  DYNJAA11087 UDI-DI 40195327694402 (case), 10195327694401 (ea) Lots 25FBG942 25FBG944;  DYNJAA11095 UDI-DI 40195327520992 (case), 10195327520991 (ea) Lots 25GBY361;  DYNJAA11126 UDI-DI 40195327695508 (case), 10195327695507 (ea) Lots 25EBV629 25GBL211;  DYNJAA6555G UDI-DI 40195327214648 (case), 10195327214647 (ea) Lots 25EBG518 25FBS747 25FBS748 25HBE691. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0442-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-0442-2026&lang=eng"
        }
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      "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-0442-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0442-2026 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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": {
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        "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-0442-2026&lang=eng",
        "value": "Class I",
        "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-0442-2026&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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0442-2026/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": {
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        "supported": 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-0442-2026",
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            "Field": "Recall number",
            "Value": "Z-0442-2026",
            "Status": "recorded"
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          "position": 2,
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            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medline Industries, LP",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120\" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.",
            "Status": "recorded"
          }
        },
        {
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-10-10",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "DYNJAA0309A UDI-DI 40193489400268 (case), 10193489400267 (ea) Lots 25EBU353 25GBI473;  DYNJAA0360 UDI DI 40193489419000 (case), 10193489419009 (ea) Lots 25EBU304 25GBQ732;  DYNJAA0368A UDI-DI 40195327092550 (case), 10195327092559 (ea) Lots 25GBH582;  DYNJAA0380A UDI-DI 40195327478286 (case), 10195327478285 (ea) Lots 25FBB950 25FBT875 25GBX623;  DYNJAA0433 UDI-DI 40198459320706 (case), 10198459320705 (ea) Lots 25EBH621 25EBQ391;  DYNJAA10261B UDI- DI 40193489430784 (case), 10193489430783 (ea) Lots 25FBJ760;  DYNJAA10368A UDI-DI 40198459320720 (case), 10198459320729 (ea) Lots 25GBY374 25IBK072;  DYNJAA10392 UDI-DI 40888277962201 (case), 10888277962200 (ea) Lots 25FBN032;  DYNJAA10430A UDI-DI 40193489832052 (case), 10193489832051 (ea) Lots 25FBW335 25IBH048;  DYNJAA10547A UDI-DI 40193489603188 (case), 10193489603187 (ea) 25FBT853;  DYNJAA10591 UDI-DI 40889942632535 (case), 10889942632534 (ea) Lots 25FBD876 25FBD877 25GBJ254 25GBJ256;  DYNJAA10601 UDI-DI 40889942655435 (case), 10889942655434 (ea) Lots 25FBN184 25HBM893;  DYNJAA10639A UDI-DI 40888277761958 (case), 10888277761957 (ea) Lots 25FBN043;  DYNJAA10641 UDI-DI 40889942841227 (case), 10889942841226 (ea) Lots 25EBK360;  DYNJAA10656A UDI-DI 40193489455527 (case), 10193489455526 (ea) Lots 25FBN055;  DYNJAA10685A UDI-DI 40195327279142 (case), 10195327279141 (ea) Lots 25EBJ456;  DYNJAA10685B UDI-DI 40198459372293 (case), 10198459372292 (ea) Lots 25FBL121 25FBT898 25FBT899;  DYNJAA10706B UDI-DI 40193489485982 (case), 10193489485981 (ea) Lots 25FBH921 25GBK879 25GBN124 25GBN125;  DYNJAA10741A UDI-DI 40193489250573 (case), 10193489250572 (ea) Lots 25EBK364 25FBQ326 25HBA472;  DYNJAA10775 UDI-DI 40193489348102 (case), 10193489348101 (ea) Lots 25GBY311 25IBD803;  DYNJAA10817 UDI-DI 40193489365338 (case), 10193489365337 (ea) Lots 25GBO619;  DYNJAA10851 UDI-DI 40193489429467 (case), 10193489429466 (ea) Lots 25GBE789 25IBL075;  DYNJAA10920 UDI-DI 40193489463386 (case), 10193489463385 (ea) Lots 25FBT844 25GBP694;  DYNJAA10922B UDI-DI 40198459301880 (case), 10198459301889 (ea) Lots 25FBQ442 25GBO675;  DYNJAA10971A UDI-DI 40195327298167 (case), 10195327298166 (ea) Lots 25GBA751;  DYNJAA10973A UDI-DI 40195327372423 (case), 10195327372422 (ea) Lots 25FBQ349;  DYNJAA11030A UDI-DI 40195327341030 (case), 10195327341039 (ea) Lots 25FBQ346;  DYNJAA11087 UDI-DI 40195327694402 (case), 10195327694401 (ea) Lots 25FBG942 25FBG944;  DYNJAA11095 UDI-DI 40195327520992 (case), 10195327520991 (ea) Lots 25GBY361;  DYNJAA11126 UDI-DI 40195327695508 (case), 10195327695507 (ea) Lots 25EBV629 25GBL211;  DYNJAA6555G UDI-DI 40195327214648 (case), 10195327214647 (ea) Lots 25EBG518 25FBS747 25FBS748 25HBE691",
            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;",
            "Status": "recorded"
          }
        }
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}