{
  "@context": {
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    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
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    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1413-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience Kits:  1) NEURO SHUNT- CODMAN, Model Number: CDS860018G;   2) NEURO SHUNT- CODMAN, Model Number: CDS860018I;   3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138;   4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142;   5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B;   6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145;   7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B;   8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5;   9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B;   10) NEURO PACK-LF, Model Number: DYNJ0305809O;   11) NEURO PACK-LF, Model Number: DYNJ0305809P;   12) NEURO PACK-LF, Model Number: DYNJ0408776Y;   13) NEURO PACK-LF, Model Number: DYNJ04596K;   14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L;   15) NEURO PACK, Model Number: DYNJ49098I;   16) NEURO PACK, Model Number: DYNJ53089B;   17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799;   18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A;   19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C;   20) NEURO PACK, Model Number: DYNJ60792B;   21) NEURO PACK, Model Number: DYNJ60792C;   22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C;   23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D;   24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D;   25) NEURO PACK, Model Number: DYNJ61740D;   26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998;   27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A;   28) DISCECTOMY PACK, Model Number: DYNJ67835;   29) WWD NEURO PACK, Model Number: DYNJ80849B;   30) WWD NEURO PACK, Model Number: DYNJ80849J;   31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A;   32) NEURO, Model Number: DYNJ900904J;   33) NEURO, Model Number: DYNJ900904K;   34) NEURO, Model Number: DYNJ900904L;   35) NEURO, Model Number: DYNJ900904M;   36) NEURO, Model Number: DYNJ902585;   37) NEURO, Model Number: DYNJ902585A;   38) NEURO - IFCAP 230316, Model Number: DYNJ908393;   39) NEURO - IFCAP 230316, Model Number: DYNJ908393A;   40) NEURO KIT, Model Number: DYNJ909573;   41) NEURO, Model Number: DYNJ910384;   42) NEURO, Model Number: DYNJ910384A;   43) NEURO PACK-LF, Model Number: PHS390015M",
  "description": "FDA recall Z-1413-2026 — Medline Industries, LP is recalling Medline Convenience Kits:  1) NEURO SHUNT- CODMAN, Model Number: CDS860018G;   2) NEURO SHUNT- CODMAN, Model Number: CDS860018I;   3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138;   4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142;   5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B;   6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145;   7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B;   8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5;   9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B;   10) NEURO PACK-LF, Model Number: DYNJ0305809O;   11) NEURO PACK-LF, Model Number: DYNJ0305809P;   12) NEURO PACK-LF, Model Number: DYNJ0408776Y;   13) NEURO PACK-LF, Model Number: DYNJ04596K;   14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L;   15) NEURO PACK, Model Number: DYNJ49098I;   16) NEURO PACK, Model Number: DYNJ53089B;   17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799;   18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A;   19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C;   20) NEURO PACK, Model Number: DYNJ60792B;   21) NEURO PACK, Model Number: DYNJ60792C;   22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C;   23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D;   24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D;   25) NEURO PACK, Model Number: DYNJ61740D;   26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998;   27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A;   28) DISCECTOMY PACK, Model Number: DYNJ67835;   29) WWD NEURO PACK, Model Number: DYNJ80849B;   30) WWD NEURO PACK, Model Number: DYNJ80849J;   31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A;   32) NEURO, Model Number: DYNJ900904J;   33) NEURO, Model Number: DYNJ900904K;   34) NEURO, Model Number: DYNJ900904L;   35) NEURO, Model Number: DYNJ900904M;   36) NEURO, Model Number: DYNJ902585;   37) NEURO, Model Number: DYNJ902585A;   38) NEURO - IFCAP 230316, Model Number: DYNJ908393;   39) NEURO - IFCAP 230316, Model Number: DYNJ908393A;   40) NEURO KIT, Model Number: DYNJ909573;   41) NEURO, Model Number: DYNJ910384;   42) NEURO, Model Number: DYNJ910384A;   43) NEURO PACK-LF, Model Number: PHS390015M (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/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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"
    }
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1413-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience Kits:  1) NEURO SHUNT- CODMAN, Model Number: CDS860018G;   2) NEURO SHUNT- CODMAN, Model Number: CDS860018I;   3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138;   4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142;   5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B;   6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145;   7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B;   8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5;   9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B;   10) NEURO PACK-LF, Model Number: DYNJ0305809O;   11) NEURO PACK-LF, Model Number: DYNJ0305809P;   12) NEURO PACK-LF, Model Number: DYNJ0408776Y;   13) NEURO PACK-LF, Model Number: DYNJ04596K;   14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L;   15) NEURO PACK, Model Number: DYNJ49098I;   16) NEURO PACK, Model Number: DYNJ53089B;   17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799;   18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A;   19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C;   20) NEURO PACK, Model Number: DYNJ60792B;   21) NEURO PACK, Model Number: DYNJ60792C;   22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C;   23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D;   24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D;   25) NEURO PACK, Model Number: DYNJ61740D;   26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998;   27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A;   28) DISCECTOMY PACK, Model Number: DYNJ67835;   29) WWD NEURO PACK, Model Number: DYNJ80849B;   30) WWD NEURO PACK, Model Number: DYNJ80849J;   31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A;   32) NEURO, Model Number: DYNJ900904J;   33) NEURO, Model Number: DYNJ900904K;   34) NEURO, Model Number: DYNJ900904L;   35) NEURO, Model Number: DYNJ900904M;   36) NEURO, Model Number: DYNJ902585;   37) NEURO, Model Number: DYNJ902585A;   38) NEURO - IFCAP 230316, Model Number: DYNJ908393;   39) NEURO - IFCAP 230316, Model Number: DYNJ908393A;   40) NEURO KIT, Model Number: DYNJ909573;   41) NEURO, Model Number: DYNJ910384;   42) NEURO, Model Number: DYNJ910384A;   43) NEURO PACK-LF, Model Number: PHS390015M",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1413-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1413-2026: Medline Industries, LP is recalling Medline Convenience Kits:  1) NEURO SHUNT- CODMAN, Model Number: CDS860018G;   2) NEURO SHUNT- CODMAN, Model Number: CDS860018I;   3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138;   4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142;   5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B;   6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145;   7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B;   8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5;   9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B;   10) NEURO PACK-LF, Model Number: DYNJ0305809O;   11) NEURO PACK-LF, Model Number: DYNJ0305809P;   12) NEURO PACK-LF, Model Number: DYNJ0408776Y;   13) NEURO PACK-LF, Model Number: DYNJ04596K;   14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L;   15) NEURO PACK, Model Number: DYNJ49098I;   16) NEURO PACK, Model Number: DYNJ53089B;   17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799;   18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A;   19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C;   20) NEURO PACK, Model Number: DYNJ60792B;   21) NEURO PACK, Model Number: DYNJ60792C;   22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C;   23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D;   24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D;   25) NEURO PACK, Model Number: DYNJ61740D;   26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998;   27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A;   28) DISCECTOMY PACK, Model Number: DYNJ67835;   29) WWD NEURO PACK, Model Number: DYNJ80849B;   30) WWD NEURO PACK, Model Number: DYNJ80849J;   31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A;   32) NEURO, Model Number: DYNJ900904J;   33) NEURO, Model Number: DYNJ900904K;   34) NEURO, Model Number: DYNJ900904L;   35) NEURO, Model Number: DYNJ900904M;   36) NEURO, Model Number: DYNJ902585;   37) NEURO, Model Number: DYNJ902585A;   38) NEURO - IFCAP 230316, Model Number: DYNJ908393;   39) NEURO - IFCAP 230316, Model Number: DYNJ908393A;   40) NEURO KIT, Model Number: DYNJ909573;   41) NEURO, Model Number: DYNJ910384;   42) NEURO, Model Number: DYNJ910384A;   43) NEURO PACK-LF, Model Number: PHS390015M",
      "text": "The FDA logged enforcement record Z-1413-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits:  1) NEURO SHUNT- CODMAN, Model Number: CDS860018G;   2) NEURO SHUNT- CODMAN, Model Number: CDS860018I;   3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138;   4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142;   5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B;   6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145;   7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B;   8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5;   9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B;   10) NEURO PACK-LF, Model Number: DYNJ0305809O;   11) NEURO PACK-LF, Model Number: DYNJ0305809P;   12) NEURO PACK-LF, Model Number: DYNJ0408776Y;   13) NEURO PACK-LF, Model Number: DYNJ04596K;   14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L;   15) NEURO PACK, Model Number: DYNJ49098I;   16) NEURO PACK, Model Number: DYNJ53089B;   17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799;   18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A;   19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C;   20) NEURO PACK, Model Number: DYNJ60792B;   21) NEURO PACK, Model Number: DYNJ60792C;   22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C;   23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D;   24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D;   25) NEURO PACK, Model Number: DYNJ61740D;   26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998;   27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A;   28) DISCECTOMY PACK, Model Number: DYNJ67835;   29) WWD NEURO PACK, Model Number: DYNJ80849B;   30) WWD NEURO PACK, Model Number: DYNJ80849J;   31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A;   32) NEURO, Model Number: DYNJ900904J;   33) NEURO, Model Number: DYNJ900904K;   34) NEURO, Model Number: DYNJ900904L;   35) NEURO, Model Number: DYNJ900904M;   36) NEURO, Model Number: DYNJ902585;   37) NEURO, Model Number: DYNJ902585A;   38) NEURO - IFCAP 230316, Model Number: DYNJ908393;   39) NEURO - IFCAP 230316, Model Number: DYNJ908393A;   40) NEURO KIT, Model Number: DYNJ909573;   41) NEURO, Model Number: DYNJ910384;   42) NEURO, Model Number: DYNJ910384A;   43) NEURO PACK-LF, Model Number: PHS390015M — reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-07. Affected lots/codes: 1) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMH970; 2) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMD444; 3) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23AMJ086; 4) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22KMF991; 5) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22HMC764; 6) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22DMD555; 7) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21LMG598; 8) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21KMD971; 9) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21JMH357; 10) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMF497; 11) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GME436; 12) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMA403; 13) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21DBD719; 14) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21CBA213; 15) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24EMI161; 16) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24CMA817; 17) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23KMB758; 18) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMI786; 19) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMA572; 20) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23IME897; 21) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23GMC110; 22) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23EME270; 23) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22OBC508; 24) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22NBA962; 25) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22IBE871; 26) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBF303; 27) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBC967; 28) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBO542; 29) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBA074; 30) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22DBD203; 31) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22BBT015; 32) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21LBL164; 33) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21JBB951; 34) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21HBN643; 35) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBS468; 36) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBG761; 37) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21FBE311; 38) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21DBE120; 39) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBP552; 40) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBA521; 41) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABU817; 42) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABL131; 43) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21BBG852; 44) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21BBB221; 45) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21ABW870; 46) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21ABL138; 47) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24LBI083; 48) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24KBK044; 49) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24KBA532; 50) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24JBS893; 51) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24GBS072; 52) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24EBQ164; 53) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24DBJ890; 54) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24CBU410; 55) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24CBA173; 56) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24ABL221; 57) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23KBK072; 58) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23IBS183; 59) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23HBT876; 60) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23GBE625; 61) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23FBE493; 62) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23DBF392; 63) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23CBP083; 64) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23CBG764; 65) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23BBU041; 66) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23ABU154; 67) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22LBR466; 68) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22KBB452; 69) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22IBN422; 70) DYKMBNDL145, UDI-DI: 10193489478365(each), 40193489478366(case), Lot Number: 21ABT643; 71) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 24HBF314; 72) DYKMBNDL5, UDI-DI: 10193489477634(each), 40193489477635(case), Lot Number: 21ABQ194; 73) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25KBQ729; 74) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25FBD172; 75) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25DBO558; 76) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25BBM404; 77) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24LBJ842; 78) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24LBH040; 79) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24GBK951; 80) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24EBC897; 81) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24DBJ607; 82) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24BBG003; 83) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23LBL844; 84) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23FBP269; 85) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23EBB597; 86) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23ABK051; 87) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 22IBJ928; 88) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23IBR967; 89) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23GBD741; 90) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23EBW271; 91) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23DBQ920; 92) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23CBI776; 93) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22OBL140; 94) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22LBL870; 95) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22JBL998; 96) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBO559; 97) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBF833; 98) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 24DBT971; 99) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 23LBR942; 100) DYNJ0408776Y, UDI-DI: 10195327115852(each), 40195327115853(case), Lot Number: 23DBS739; 101) DYNJ04596K, UDI-DI: 10193489301342(each), 40193489301343(case), Lot Number: 23KMD949; 102) DYNJ35243L, UDI-DI: 10195327638733(each), 40195327638734(case), Lot Number: 24FMB808; 103) DYNJ49098I, UDI-DI: 10193489712100(each), 40193489712101(case), Lot Number: 21BBP868; 104) DYNJ53089B, UDI-DI: 10193489335248(each), 40193489335249(case), Lot Number: 21BBA722; 105) DYNJ53799, UDI-DI: 10889942444557(each), 40889942444558(case), Lot Number: 21ADA264; 106) DYNJ58704A, UDI-DI: 10193489502053(each), 40193489502054(case), Lot Number: 23CBT449; 107) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21KLA157; 108) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA398; 109) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA233; 110) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21GLB218; 111) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 22ABJ128; 112) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21FBS847; 113) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR913; 114) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR912; 115) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBO518; 116) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBJ319; 117) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21CBC497; 118) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23LBN124; 119) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23KBH242; 120) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23HBY836; 121) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23EBM305; 122) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23DBB793; 123) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23CBE668; 124) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22OBE182; 125) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22HBN525; 126) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23LBG606; 127) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23KBP559; 128) DYNJ61157D, UDI-DI: 10195327605919(each), 40195327605910(case), Lot Number: 24ABQ754; 129) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25KBL642; 130) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBR218; 131) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBG888; 132) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25ABG065; 133) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24IBQ689; 134) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24GBA833; 135) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24CBB175; 136) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBX534; 137) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBP375; 138) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22ABL607; 139) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBE011; 140) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB714; 141) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB713; 142) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21KBA371; 143) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21DBV445; 144) DYNJ61998, UDI-DI: 10193489615012(each), 40193489615013(case), Lot Number: 23EBV072; 145) DYNJ64570A, UDI-DI: 10195327242800(each), 40195327242801(case), Lot Number: 22LBK925; 146) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23GBG567; 147) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23FBJ662; 148) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23DBP210; 149) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBT224; 150) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBR140; 151) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23BBS499; 152) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22LBK279; 153) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22IBV281; 154) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22GBR040; 155) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22EBL897; 156) DYNJ80849B, UDI-DI: 10195327443689(each), 40195327443680(case), Lot Number: 23GBF525; 157) DYNJ80849J, UDI-DI: 10198459561245(each), 40198459561246(case), Lot Number: 25KBJ851; 158) DYNJ84653A, UDI-DI: 10195327697419(each), 40195327697410(case), Lot Number: 24GBU616; 159) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22OBE679; 160) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22KBC323; 161) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22JBY355; 162) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBR893; 163) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ992; 164) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ991; 165) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22ELA806; 166) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22EBB675; 167) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22CLA766; 168) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21LBG281; 169) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21JBQ824; 170) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21HBI172; 171) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21GBF913; 172) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25BME471; 173) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25AMG870; 174) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24LMD278; 175) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24KMG047; 176) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMF168; 177) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMB004; 178) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24HMA754; 179) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24FMF700; 180) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMH051; 181) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMB555; 182) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24CBN849; 183) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24ABH283; 184) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23KBH986; 185) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23JBF549; 186) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23HBQ501; 187) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23GBW505; 188) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBV444; 189) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBN975; 190) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABR127; 191) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABC415; 192) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25FMG005; 193) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMJ902; 194) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMG513; 195) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25DME524; 196) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25CMJ212; 197) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25HMI564; 198) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25GMI512; 199) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21GDB745; 200) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21FDA224; 201) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21EDA724; 202) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21CDB697; 203) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25DDB556; 204) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25ADA139; 205) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24LDA154; 206) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24JDC387; 207) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24GDA318; 208) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24CDA135; 209) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23IDB360; 210) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23FDA576; 211) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23ADA425; 212) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22IDA639; 213) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22HDB311; 214) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22GDB053; 215) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22FDB376; 216) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21LDA963; 217) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21JDC066; 218) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21IDB884; 219) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23GDA913; 220) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23FDB736; 221) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23EDB018; 222) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23BDB148; 223) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22LDA043; 224) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDB239; 225) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDA609; 226) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22HDC481; 227) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDB437; 228) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDA427; 229) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22EDA370; 230) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22BDB502; 231) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 23KDA234; 232) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25FLA327; 233) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25DLA489; 234) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24FBF785; 235) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24EBH096; 236) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25DBC086; 237) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF621; 238) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF584; 239) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25BBN770; 240) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25ABA025; 241) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 24JBQ224; 242) PHS390015M, UDI-DI: 10193489333824(each), 40193489333825(case), Lot Number: 20LMD456. 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-1413-2026&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-1413-2026&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-1413-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1413-2026 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",
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      "epistemicStatus": {
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        "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-1413-2026&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-1413-2026&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-1413-2026/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-1413-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1413-2026",
            "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 has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-01-07",
            "Status": "recorded"
          }
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80) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24EBC897; 81) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24DBJ607; 82) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24BBG003; 83) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23LBL844; 84) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23FBP269; 85) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23EBB597; 86) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23ABK051; 87) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 22IBJ928; 88) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23IBR967; 89) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23GBD741; 90) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23EBW271; 91) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23DBQ920; 92) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23CBI776; 93) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22OBL140; 94) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22LBL870; 95) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22JBL998; 96) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBO559; 97) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBF833; 98) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 24DBT971; 99) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 23LBR942; 100) DYNJ0408776Y, UDI-DI: 10195327115852(each), 40195327115853(case), Lot Number: 23DBS739; 101) DYNJ04596K, UDI-DI: 10193489301342(each), 40193489301343(case), Lot Number: 23KMD949; 102) DYNJ35243L, UDI-DI: 10195327638733(each), 40195327638734(case), Lot Number: 24FMB808; 103) DYNJ49098I, UDI-DI: 10193489712100(each), 40193489712101(case), Lot Number: 21BBP868; 104) DYNJ53089B, UDI-DI: 10193489335248(each), 40193489335249(case), Lot Number: 21BBA722; 105) DYNJ53799, UDI-DI: 10889942444557(each), 40889942444558(case), Lot Number: 21ADA264; 106) DYNJ58704A, UDI-DI: 10193489502053(each), 40193489502054(case), Lot Number: 23CBT449; 107) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21KLA157; 108) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA398; 109) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA233; 110) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21GLB218; 111) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 22ABJ128; 112) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21FBS847; 113) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR913; 114) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR912; 115) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBO518; 116) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBJ319; 117) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21CBC497; 118) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23LBN124; 119) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23KBH242; 120) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23HBY836; 121) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23EBM305; 122) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23DBB793; 123) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23CBE668; 124) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22OBE182; 125) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22HBN525; 126) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23LBG606; 127) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23KBP559; 128) DYNJ61157D, UDI-DI: 10195327605919(each), 40195327605910(case), Lot Number: 24ABQ754; 129) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25KBL642; 130) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBR218; 131) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBG888; 132) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25ABG065; 133) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24IBQ689; 134) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24GBA833; 135) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24CBB175; 136) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBX534; 137) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBP375; 138) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22ABL607; 139) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBE011; 140) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB714; 141) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB713; 142) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21KBA371; 143) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21DBV445; 144) DYNJ61998, UDI-DI: 10193489615012(each), 40193489615013(case), Lot Number: 23EBV072; 145) DYNJ64570A, UDI-DI: 10195327242800(each), 40195327242801(case), Lot Number: 22LBK925; 146) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23GBG567; 147) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23FBJ662; 148) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23DBP210; 149) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBT224; 150) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBR140; 151) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23BBS499; 152) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22LBK279; 153) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22IBV281; 154) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22GBR040; 155) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22EBL897; 156) DYNJ80849B, UDI-DI: 10195327443689(each), 40195327443680(case), Lot Number: 23GBF525; 157) DYNJ80849J, UDI-DI: 10198459561245(each), 40198459561246(case), Lot Number: 25KBJ851; 158) DYNJ84653A, UDI-DI: 10195327697419(each), 40195327697410(case), Lot Number: 24GBU616; 159) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22OBE679; 160) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22KBC323; 161) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22JBY355; 162) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBR893; 163) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ992; 164) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ991; 165) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22ELA806; 166) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22EBB675; 167) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22CLA766; 168) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21LBG281; 169) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21JBQ824; 170) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21HBI172; 171) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21GBF913; 172) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25BME471; 173) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25AMG870; 174) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24LMD278; 175) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24KMG047; 176) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMF168; 177) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMB004; 178) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24HMA754; 179) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24FMF700; 180) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMH051; 181) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMB555; 182) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24CBN849; 183) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24ABH283; 184) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23KBH986; 185) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23JBF549; 186) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23HBQ501; 187) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23GBW505; 188) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBV444; 189) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBN975; 190) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABR127; 191) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABC415; 192) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25FMG005; 193) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMJ902; 194) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMG513; 195) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25DME524; 196) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25CMJ212; 197) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25HMI564; 198) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25GMI512; 199) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21GDB745; 200) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21FDA224; 201) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21EDA724; 202) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21CDB697; 203) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25DDB556; 204) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25ADA139; 205) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24LDA154; 206) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24JDC387; 207) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24GDA318; 208) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24CDA135; 209) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23IDB360; 210) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23FDA576; 211) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23ADA425; 212) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22IDA639; 213) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22HDB311; 214) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22GDB053; 215) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22FDB376; 216) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21LDA963; 217) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21JDC066; 218) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21IDB884; 219) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23GDA913; 220) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23FDB736; 221) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23EDB018; 222) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23BDB148; 223) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22LDA043; 224) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDB239; 225) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDA609; 226) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22HDC481; 227) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDB437; 228) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDA427; 229) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22EDA370; 230) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22BDB502; 231) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 23KDA234; 232) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25FLA327; 233) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25DLA489; 234) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24FBF785; 235) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24EBH096; 236) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25DBC086; 237) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF621; 238) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF584; 239) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25BBN770; 240) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25ABA025; 241) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 24JBQ224; 242) PHS390015M, UDI-DI: 10193489333824(each), 40193489333825(case), Lot Number: 20LMD456",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}