{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "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"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0908-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Cardinal Health Presource Kits:  1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951;   2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952;   3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910;   4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911;   5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912;   6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913;   7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914;   8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951;   9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952;   10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953;   11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954;   12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955;   13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956;   14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957;   15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958;   16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959;   17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A;   18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C;   19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F;   20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G;   21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1;   22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2;   23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB;   24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC;   25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD;   26) DIEP PACK,Catalog Number SBA11DPS10;   27) DIEP PACK,Catalog Number SBA11DPS11;   28) DIEP PACK,Catalog Number SBA11DPS12;   29) DIEP PACK,Catalog Number SBA11DPS13;   30) DIEP PACK,Catalog Number SBA11DPS14;   31) DIEP PACK,Catalog Number SBA11DPS15;   32) DIEP PACK,Catalog Number SBA11DPS16;   33) DIEP PACK,Catalog Number SBA11DPS17;   34) DIEP PACK,Catalog Number SBA11DPS18;   35) DIEP PACK,Catalog Number SBA11DPS19;   36) DIEP PACK,Catalog Number SBA11DPS20;   37) DIEP PACK,Catalog Number SBA11DPS21;   38) DIEP PACK,Catalog Number SBA11DPS22;   39) DIEP PACK,Catalog Number SBA11DPSB4;   40) DIEP PACK,Catalog Number SBA11DPSB5;   41) DIEP PACK,Catalog Number SBA11DPSB6;   42) DIEP PACK,Catalog Number SBA11DPSB7;   43) DIEP PACK,Catalog Number SBA11DPSB8;   44) DIEP PACK,Catalog Number SBA11DPSB9;   45) DIEP PACK,Catalog Number SBA11DPSBD;   46) DIEP PACK,Catalog Number SBA11DPSBE;   47) DIEP PACK,Catalog Number SBA11DPSBF;   48) DIEP PACK,Catalog Number SBA11DPSBG;   49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1;   50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2;   51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3;   52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4;   53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5;   54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6;   55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB;   56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC;   57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD;   58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE;   59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10;   60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11;   61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12;   62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13;   63) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH14;   64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3;   65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4;   66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5;   67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6;   68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7;   69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8;   70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9;   71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB;   72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC;   73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF;   74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG;   75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C;   76) DIEP SIEP PACK,Catalo",
  "description": "FDA recall Z-0908-2025 — Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits:  1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951;   2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952;   3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910;   4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911;   5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912;   6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913;   7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914;   8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951;   9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952;   10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953;   11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954;   12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955;   13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956;   14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957;   15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958;   16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959;   17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A;   18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C;   19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F;   20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G;   21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1;   22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2;   23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB;   24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC;   25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD;   26) DIEP PACK,Catalog Number SBA11DPS10;   27) DIEP PACK,Catalog Number SBA11DPS11;   28) DIEP PACK,Catalog Number SBA11DPS12;   29) DIEP PACK,Catalog Number SBA11DPS13;   30) DIEP PACK,Catalog Number SBA11DPS14;   31) DIEP PACK,Catalog Number SBA11DPS15;   32) DIEP PACK,Catalog Number SBA11DPS16;   33) DIEP PACK,Catalog Number SBA11DPS17;   34) DIEP PACK,Catalog Number SBA11DPS18;   35) DIEP PACK,Catalog Number SBA11DPS19;   36) DIEP PACK,Catalog Number SBA11DPS20;   37) DIEP PACK,Catalog Number SBA11DPS21;   38) DIEP PACK,Catalog Number SBA11DPS22;   39) DIEP PACK,Catalog Number SBA11DPSB4;   40) DIEP PACK,Catalog Number SBA11DPSB5;   41) DIEP PACK,Catalog Number SBA11DPSB6;   42) DIEP PACK,Catalog Number SBA11DPSB7;   43) DIEP PACK,Catalog Number SBA11DPSB8;   44) DIEP PACK,Catalog Number SBA11DPSB9;   45) DIEP PACK,Catalog Number SBA11DPSBD;   46) DIEP PACK,Catalog Number SBA11DPSBE;   47) DIEP PACK,Catalog Number SBA11DPSBF;   48) DIEP PACK,Catalog Number SBA11DPSBG;   49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1;   50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2;   51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3;   52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4;   53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5;   54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6;   55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB;   56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC;   57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD;   58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE;   59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10;   60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11;   61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12;   62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13;   63) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH14;   64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3;   65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4;   66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5;   67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6;   68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7;   69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8;   70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9;   71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB;   72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC;   73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF;   74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG;   75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C;   76) DIEP SIEP PACK,Catalo (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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0908-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Cardinal Health Presource Kits:  1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951;   2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952;   3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910;   4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911;   5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912;   6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913;   7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914;   8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951;   9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952;   10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953;   11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954;   12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955;   13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956;   14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957;   15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958;   16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959;   17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A;   18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C;   19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F;   20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G;   21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1;   22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2;   23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB;   24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC;   25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD;   26) DIEP PACK,Catalog Number SBA11DPS10;   27) DIEP PACK,Catalog Number SBA11DPS11;   28) DIEP PACK,Catalog Number SBA11DPS12;   29) DIEP PACK,Catalog Number SBA11DPS13;   30) DIEP PACK,Catalog Number SBA11DPS14;   31) DIEP PACK,Catalog Number SBA11DPS15;   32) DIEP PACK,Catalog Number SBA11DPS16;   33) DIEP PACK,Catalog Number SBA11DPS17;   34) DIEP PACK,Catalog Number SBA11DPS18;   35) DIEP PACK,Catalog Number SBA11DPS19;   36) DIEP PACK,Catalog Number SBA11DPS20;   37) DIEP PACK,Catalog Number SBA11DPS21;   38) DIEP PACK,Catalog Number SBA11DPS22;   39) DIEP PACK,Catalog Number SBA11DPSB4;   40) DIEP PACK,Catalog Number SBA11DPSB5;   41) DIEP PACK,Catalog Number SBA11DPSB6;   42) DIEP PACK,Catalog Number SBA11DPSB7;   43) DIEP PACK,Catalog Number SBA11DPSB8;   44) DIEP PACK,Catalog Number SBA11DPSB9;   45) DIEP PACK,Catalog Number SBA11DPSBD;   46) DIEP PACK,Catalog Number SBA11DPSBE;   47) DIEP PACK,Catalog Number SBA11DPSBF;   48) DIEP PACK,Catalog Number SBA11DPSBG;   49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1;   50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2;   51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3;   52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4;   53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5;   54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6;   55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB;   56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC;   57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD;   58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE;   59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10;   60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11;   61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12;   62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13;   63) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH14;   64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3;   65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4;   66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5;   67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6;   68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7;   69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8;   70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9;   71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB;   72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC;   73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF;   74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG;   75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C;   76) DIEP SIEP PACK,Catalo",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cardinal Health 200, LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0908-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0908-2025: Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits:  1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951;   2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952;   3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910;   4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911;   5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912;   6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913;   7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914;   8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951;   9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952;   10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953;   11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954;   12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955;   13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956;   14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957;   15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958;   16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959;   17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A;   18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C;   19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F;   20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G;   21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1;   22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2;   23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB;   24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC;   25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD;   26) DIEP PACK,Catalog Number SBA11DPS10;   27) DIEP PACK,Catalog Number SBA11DPS11;   28) DIEP PACK,Catalog Number SBA11DPS12;   29) DIEP PACK,Catalog Number SBA11DPS13;   30) DIEP PACK,Catalog Number SBA11DPS14;   31) DIEP PACK,Catalog Number SBA11DPS15;   32) DIEP PACK,Catalog Number SBA11DPS16;   33) DIEP PACK,Catalog Number SBA11DPS17;   34) DIEP PACK,Catalog Number SBA11DPS18;   35) DIEP PACK,Catalog Number SBA11DPS19;   36) DIEP PACK,Catalog Number SBA11DPS20;   37) DIEP PACK,Catalog Number SBA11DPS21;   38) DIEP PACK,Catalog Number SBA11DPS22;   39) DIEP PACK,Catalog Number SBA11DPSB4;   40) DIEP PACK,Catalog Number SBA11DPSB5;   41) DIEP PACK,Catalog Number SBA11DPSB6;   42) DIEP PACK,Catalog Number SBA11DPSB7;   43) DIEP PACK,Catalog Number SBA11DPSB8;   44) DIEP PACK,Catalog Number SBA11DPSB9;   45) DIEP PACK,Catalog Number SBA11DPSBD;   46) DIEP PACK,Catalog Number SBA11DPSBE;   47) DIEP PACK,Catalog Number SBA11DPSBF;   48) DIEP PACK,Catalog Number SBA11DPSBG;   49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1;   50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2;   51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3;   52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4;   53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5;   54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6;   55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB;   56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC;   57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD;   58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE;   59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10;   60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11;   61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12;   62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13;   63) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH14;   64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3;   65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4;   66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5;   67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6;   68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7;   69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8;   70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9;   71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB;   72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC;   73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF;   74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG;   75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C;   76) DIEP SIEP PACK,Catalo",
      "text": "The FDA logged enforcement record Z-0908-2025: Cardinal Health 200, LLC is voluntarily recalling Cardinal Health Presource Kits:  1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951;   2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952;   3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910;   4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911;   5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912;   6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913;   7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914;   8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951;   9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952;   10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953;   11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954;   12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955;   13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956;   14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957;   15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958;   16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959;   17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A;   18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C;   19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F;   20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G;   21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1;   22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2;   23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB;   24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC;   25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD;   26) DIEP PACK,Catalog Number SBA11DPS10;   27) DIEP PACK,Catalog Number SBA11DPS11;   28) DIEP PACK,Catalog Number SBA11DPS12;   29) DIEP PACK,Catalog Number SBA11DPS13;   30) DIEP PACK,Catalog Number SBA11DPS14;   31) DIEP PACK,Catalog Number SBA11DPS15;   32) DIEP PACK,Catalog Number SBA11DPS16;   33) DIEP PACK,Catalog Number SBA11DPS17;   34) DIEP PACK,Catalog Number SBA11DPS18;   35) DIEP PACK,Catalog Number SBA11DPS19;   36) DIEP PACK,Catalog Number SBA11DPS20;   37) DIEP PACK,Catalog Number SBA11DPS21;   38) DIEP PACK,Catalog Number SBA11DPS22;   39) DIEP PACK,Catalog Number SBA11DPSB4;   40) DIEP PACK,Catalog Number SBA11DPSB5;   41) DIEP PACK,Catalog Number SBA11DPSB6;   42) DIEP PACK,Catalog Number SBA11DPSB7;   43) DIEP PACK,Catalog Number SBA11DPSB8;   44) DIEP PACK,Catalog Number SBA11DPSB9;   45) DIEP PACK,Catalog Number SBA11DPSBD;   46) DIEP PACK,Catalog Number SBA11DPSBE;   47) DIEP PACK,Catalog Number SBA11DPSBF;   48) DIEP PACK,Catalog Number SBA11DPSBG;   49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1;   50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2;   51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3;   52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4;   53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5;   54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6;   55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB;   56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC;   57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD;   58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE;   59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10;   60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11;   61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12;   62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13;   63) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH14;   64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3;   65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4;   66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5;   67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6;   68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7;   69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8;   70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9;   71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB;   72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC;   73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF;   74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG;   75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C;   76) DIEP SIEP PACK,Catalo — reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-08. Affected lots/codes: Catalog Number PGHDOT951, UDI/DI 10888439692228 (EA)50888439692226 (CS), Lot Number  J4952D  ;  Catalog Number PGHDOT952, UDI/DI 10888439821260 (EA)50888439821268 (CS), Lot Number  J6050F  ;  Catalog Number PWHDOT910, UDI/DI 10197106435052 (EA)50197106435050 (CS), Lot Number  6788561 ;  Catalog Number PWHDOT911, UDI/DI 10197106646724 (EA)50197106646722 (CS), Lot Number  7332903 ;  Catalog Number PWHDOT912, UDI/DI 10197106673195 (EA)50197106673193 (CS), Lot Number  7163082 ;  Catalog Number PWHDOT913, UDI/DI 10197106713365 (EA)50197106713363 (CS), Lot Number  7332912 ;  Catalog Number PWHDOT914, UDI/DI 10197106718834 (EA)50197106718832 (CS), Lot Number  7332914 ;  Catalog Number PWHDOT951, UDI/DI 10888439940176 (EA)50888439940174 (CS), Lot Number  J84K02  ;  Catalog Number PWHDOT952, UDI/DI 10195594331474 (EA)50195594331472 (CS), Lot Number  J6278U  ;  Catalog Number PWHDOT953, UDI/DI 10195594505493 (EA)50195594505491 (CS), Lot Number  5664102 ;  Catalog Number PWHDOT954, UDI/DI 10195594555559 (EA)50195594555557 (CS), Lot Number  5664101 ;  Catalog Number PWHDOT955, UDI/DI 10195594646134 (EA)50195594646132 (CS), Lot Number  5891310 ;  Catalog Number PWHDOT956, UDI/DI 10195594697884 (EA)50195594697882 (CS), Lot Number  5891313 ;  Catalog Number PWHDOT957, UDI/DI 10197106129982 (EA)50197106129980 (CS), Lot Number  6563987 ;  Catalog Number PWHDOT958, UDI/DI 10197106188095 (EA)50197106188093 (CS), Lot Number  6563989 ;  Catalog Number PWHDOT959, UDI/DI 10197106329771 (EA)50197106329779 (CS), Lot Number  6701853 ;  Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number  J8671K  ;  Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number  J8671M  ;  Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number  J8671P  ;  Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number  J86T83  ;  Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number  5405627 ;  Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number  6487902 ;  Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number  6169297 ;  Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number  6264570 ;  Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number  6264565 ;  Catalog Number PWHDOT95G, UDI/DI 10197106473740 (EA)50197106473748 (CS), Lot Number  6928765 ;  Catalog Number PWHDOT95G, UDI/DI 10197106473740 (EA)50197106473748 (CS), Lot Number  7163033 ;  Catalog Number PWOCRHGV1, UDI/DI 10197106262788 (EA)50197106262786 (CS), Lot Number  6701852 ;  Catalog Number PWOCRHGV2, UDI/DI 10197106349755 (EA)50197106349753 (CS), Lot Number  6487903 ;  Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number  J53W72  ;  Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number  J5679F  ;  Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number  J6050F  ;  Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number  J84K04  ;  Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number  J8124A  ;  Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number  J8671N  ;  Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number  J8123Y  ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  7332915 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  22174441       ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6702009 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6596397 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6928759 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6806115 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6928764 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6928773 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  7163104 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  7280111 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  7287567 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  7280109 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  7163082 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  7332904 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  5140347 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  5664101 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  5891309 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  5891308 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  5891310 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  5891312 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  J6367H  ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  5891313 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6022128 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6025791 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6345522 ;  Catalog Number SBA11CMCPD, UDI/DI 10888439548174 (EA)50888439548172 (CS), Lot Number  J3464F  ;  Catalog Number SBA11DPS10, UDI/DI 10195594317010 (EA)50195594317018 (CS), Lot Number  5478803 ;  Catalog Number SBA11DPS11, UDI/DI 10195594401580 (EA)50195594401588 (CS), Lot Number  5478803 ;  Catalog Number SBA11DPS12, UDI/DI 10195594541651 (EA)50195594541659 (CS), Lot Number  5888374 ;  Catalog Number SBA11DPS13, UDI/DI 10195594615192 (EA)50195594615190 (CS), Lot Number  5891311 ;  Catalog Number SBA11DPS14, UDI/DI 10195594676995 (EA)50195594676993 (CS), Lot Number  5891305 ;  Catalog Number SBA11DPS15, UDI/DI 10195594795788 (EA)50195594795786 (CS), Lot Number  6025787 ;  Catalog Number SBA11DPS16, UDI/DI 10195594885267 (EA)50195594885265 (CS), Lot Number  5631069 ;  Catalog Number SBA11DPS17, UDI/DI 10197106193761 (EA)50197106193769 (CS), Lot Number  6560944 ;  Catalog Number SBA11DPS18, UDI/DI 10197106320099 (EA)50197106320097 (CS), Lot Number  6701853 ;  Catalog Number SBA11DPS19, UDI/DI 10197106369456 (EA)50197106369454 (CS), Lot Number  6806113 ;  Catalog Number SBA11DPS20, UDI/DI 10197106507544 (EA)50197106507542 (CS), Lot Number  6928764 ;  Catalog Number SBA11DPS21, UDI/DI 10197106584798 (EA)50197106584796 (CS), Lot Number  7163104 ;  Catalog Number SBA11DPS22, UDI/DI 10197106769782 (EA)50197106769780 (CS), Lot Number  7280108 ;  Catalog Number SBA11DPSB4, UDI/DI 10888439689150 (EA)50888439689158 (CS), Lot Number  J53W67  ;  Catalog Number SBA11DPSB5, UDI/DI 10888439763836 (EA)50888439763834 (CS), Lot Number  J53W73  ;  Catalog Number SBA11DPSB6, UDI/DI 10888439995633 (EA)50888439995631 (CS), Lot Number  J8671M  ;  Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number  J9602T  ;  Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number  1933731664     ;  Catalog Number SBA11DPSB8, UDI/DI 10195594075415 (EA)50195594075413 (CS), Lot Number  5135984 ;  Catalog Number SBA11DPSB9, UDI/DI 10195594211462 (EA)50195594211460 (CS), Lot Number  5136018 ;  Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number  J34J43  ;  Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number  J46A99  ;  Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number  J70X20  ;  Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number  J8393U  ;  Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number  J8123Y  ;  Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number  J8671K  ;  Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number  J8692Z  ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6806114 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6928758 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  5631072 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  5891307 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  5891310 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  5631071 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  55693537       ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6264570 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6264566 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6264567 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6345523 ;  Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number  7280111 ;  Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number  7287567 ;  Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number  7332916 ;  Catalog Number SBA11MXCP1, UDI/DI 10195594114985 (EA)50195594114983 (CS), Lot Number  5140342 ;  Catalog Number SBA11MXCP2, UDI/DI 10195594347819 (EA)50195594347817 (CS), Lot Number  5478804 ;  Catalog Number SBA11MXCP3, UDI/DI 10195594366544 (EA)50195594366542 (CS), Lot Number  J6367F  ;  Catalog Number SBA11MXCP4, UDI/DI 10195594416027 (EA)50195594416025 (CS), Lot Number  5533336 ;  Catalog Number SBA11MXCP5, UDI/DI 10195594756369 (EA)50195594756367 (CS), Lot Number  6022131 ;  Catalog Number SBA11MXCP6, UDI/DI 10195594796587 (EA)50195594796585 (CS), Lot Number  6025787 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6563989 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  J86T81  ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6025787 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6264570 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6345522 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6487902 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6487902 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6487904 ;  Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number  6487901 ;  Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number  6596397 ;  Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number  6788562 ;  Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number  6928760 ;  Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number  6928760 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7332917 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7163033 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7163103 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7280107 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7332910 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7332906 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7332907 ;  Catalog Number SBA11PRH10, UDI/DI 10195594702298 (EA)50195594702296 (CS), Lot Number  5891314 ;  Catalog Number SBA11PRH11, UDI/DI 10195594765477 (EA)50195594765475 (CS), Lot Number  6025786 ;  Catalog Number SBA11PRH12, UDI/DI 10197106016053 (EA)50197106016051 (CS), Lot Number  6025791 ;  Catalog Number SBA11PRH13, UDI/DI 10197106100172 (EA)50197106100170 (CS), Lot Number  6345522 ;  Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number  157467  ;  Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number  22L3440 ;  Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number  6596396 ;  Catalog Number SBA11PRHK3, UDI/DI 10888439745429 (EA)50888439745427 (CS), Lot Number  J3464F  ;  Catalog Number SBA11PRHK4, UDI/DI 10888439947441 (EA)50888439947449 (CS), Lot Number  J8124A  ;  Catalog Number SBA11PRHK5, UDI/DI 10888439992335 (EA)50888439992333 (CS), Lot Number  J8692Y  ;  Catalog Number SBA11PRHK6, UDI/DI 10195594967062 (EA)50195594967060 (CS), Lot Number  J86T83  ;  Catalog Number SBA11PRHK7, UDI/DI 10195594464950 (EA)50195594464958 (CS), Lot Number  5631074 ;  Catalog Number SBA11PRHK8, UDI/DI 10195594542108 (EA)50195594542106 (CS), Lot Number  5888374 ;  Catalog Number SBA11PRHK9, UDI/DI 10195594659974 (EA)50195594659972 (CS), Lot Number  5891312 ;  Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number  J4952D  ;  Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number  J5679G  ;  Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number  J7704H  ;  Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number  J8123W  ;  Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number  J84K01  ;  Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number  5747232 ;  Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number  6806115 ;  Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number  6928766 ;  Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number  6928766 ;  Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number  6928769 ;  Catalog Number SBA11PRHKG, UDI/DI 10197106582015 (EA)50197106582013 (CS), Lot Number  7332917 ;  Catalog Number SBA11PRHKG, UDI/DI 10197106582015 (EA)50197106582013 (CS), Lot Number  7332909 ;  Catalog Number SBA12TR38C, UDI/DI 10887488792613 (EA)50887488792611 (CS), Lot Number  J3987C  ;  Catalog Number SBA12TR38C, UDI/DI 10887488792613 (EA)50887488792611 (CS), Lot Number  J4678G  ;  Catalog Number SBA13DSBW5, UDI/DI 10888439895087 (EA)50888439895085 (CS), Lot Number  J5679K  ;  Catalog Number SBA13DSBW6, UDI/DI 10195594078287 (EA)50195594078285 (CS), Lot Number  5135984 ;  Catalog Number SBA13DSBW7, UDI/DI 10195594128234 (EA)50195594128232 (CS), Lot Number  J6367C  ;  Catalog Number SBA13DSBW8, UDI/DI 10195594208615 (EA)50195594208613 (CS), Lot Number  5140342 ;  Catalog Number SBA13DSBW8, UDI/DI 10195594208615 (EA)50195594208613 (CS), Lot Number  5140354 ;  Catalog Number SBA13DSBWF, UDI/DI 10887488334868 (EA)50887488334866 (CS), Lot Number  J3464F  ;  Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number  J34J42  ;  Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number  J43U77  ;  Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number  J53W72  ;  Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number  J7963G  ;  Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number  J7963H  ;  Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number  J7905G  ;  Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number  J8123Z  ;  Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number  2003505164     ;  Catalog Number SBA13DSBWI, UDI/DI 10195594390129 (EA)50195594390127 (CS), Lot Number  5664102 ;  Catalog Number SBA13DSBWI, UDI/DI 10195594390129 (EA)50195594390127 (CS), Lot Number  5664101 ;  Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number  5891312 ;  Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number  5891314 ;  Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number  5891313 ;  Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number  6022131 ;  Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number  18B0346 ;  Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number  18K2934 ;  Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number  19A0125 ;  Catalog Number SBA13TCBCD, UDI/DI 10888439177909 (EA)50888439177907 (CS), Lot Number  J3464F  ;  Catalog Number SBA13TCBCD, UDI/DI 10888439177909 (EA)50888439177907 (CS), Lot Number  J4218Z  ;  Catalog Number SBA53FFK10, UDI/DI 10197106338612 (EA)50197106338610 (CS), Lot Number  6702010 ;  Catalog Number SBA53FFK11, UDI/DI 10197106494592 (EA)50197106494590 (CS), Lot Number  6928765 ;  Catalog Number SBA53FFK12, UDI/DI 10197106655085 (EA)50197106655083 (CS), Lot Number  7331342 ;  Catalog Number SBA53FFKH1, UDI/DI 10195594021399 (EA)50195594021397 (CS), Lot Number  J9602T  ;  Catalog Number SBA53FFKH2, UDI/DI 10195594042035 (EA)50195594042033 (CS), Lot Number  J8692W  ;  Catalog Number SBA53FFKH3, UDI/DI 10195594586843 (EA)50195594586841 (CS), Lot Number  5891309 ;  Catalog Number SBA53FFKH4, UDI/DI 10195594813390 (EA)50195594813398 (CS), Lot Number  5891315 ;  Catalog Number SBA53FFKH5, UDI/DI 10197106018569 (EA)50197106018567 (CS), Lot Number  6025791 ;  Catalog Number SBA53FFKH6, UDI/DI 10197106041987 (EA)50197106041985 (CS), Lot Number  6264570 ;  Catalog Number SBA53FFKH7, UDI/DI 10197106083475 (EA)50197106083473 (CS), Lot Number  6264569 ;  Catalog Number SBA53FFKH8, UDI/DI 10197106180280 (EA)50197106180288 (CS), Lot Number  6560945 ;  Catalog Number SBA53FFKH9, UDI/DI 10197106261156 (EA)50197106261154 (CS), Lot Number  6701852 ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  J7963H  ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  J8123W  ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  J84K01  ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  J8393W  ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  J8124A  ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  PO170874       ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  J8693A  ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  N/A     ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  J86T82  ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  J9849F  ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  5136018 ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  5618932 ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  5631074 ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  5891312 ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  5970334 ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  6025786 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332907 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332917 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  6596397 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  6928757 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  6928763 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7127056 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332904 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332914 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332916 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332905 ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  J8671M  ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  J8692W  ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  5405626 ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  J6367F  ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  5664099 ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  5876883 ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  5891312 ;  Catalog Number SBA5DFGUMC, UDI/DI 10197106675984 (EA)50197106675982 (CS), Lot Number  7332910 ;  Catalog Number SBA5FSPMM5, UDI/DI 10195594918965 (EA)50195594918963 (CS), Lot Number  J8671P  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J3464F  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J34J41  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J46C02  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J4952D  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J53W68  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J46C03  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J5679A  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J7704G  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J8064Y  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J86T81  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J9602T  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J6050H  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5140342 ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5478803 ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5664099 ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5140345 ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5664103 ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5891312 ;  Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number  7127056 ;  Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number  7280109 ;  Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number  7331342 ;  Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number  7332910 ;  Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number  7332912 ;  Catalog Number SBA60POLHB, UDI/DI 10197106730492 (EA)50197106730490 (CS), Lot Number  7332913 ;  Catalog Number SBA60POLHB, UDI/DI 10197106730492 (EA)50197106730490 (CS), Lot Number  7332918 ;  Catalog Number SBA73FFKO1, UDI/DI 10197106347904 (EA)50197106347902 (CS), Lot Number  6702012 ;  Catalog Number SBA73FFKOA, UDI/DI 10197106288252 (EA)50197106288250 (CS), Lot Number  7163103 ;  Catalog Number SBA73FFKOA, UDI/DI 10197106288252 (EA)50197106288250 (CS), Lot Number  6928771 ;  Catalog Number SBA73FFKWB, UDI/DI 10197106744550 (EA)50197106744558 (CS), Lot Number  7332915 ;  Catalog Number SBA73FFKWB, UDI/DI 10197106744550 (EA)50197106744558 (CS), Lot Number  7332908 ;  Catalog Number SBAMHMFB10, UDI/DI 10195594132552 (EA)50195594132550 (CS), Lot Number  J6050H  ;  Catalog Number SBAMHMFB11, UDI/DI 10195594249212 (EA)50195594249210 (CS), Lot Number  5140342 ;  Catalog Number SBAMHMFB12, UDI/DI 10195594393137 (EA)50195594393135 (CS), Lot Number  5533333 ;  Catalog Number SBAMHMFB13, UDI/DI 10195594520359 (EA)50195594520357 (CS), Lot Number  5140345 ;  Catalog Number SBAMHMFB14, UDI/DI 10195594546144 (EA)50195594546142 (CS), Lot Number  5876883 ;  Catalog Number SBAMHMFB15, UDI/DI 10197106118993 (EA)50197106118991 (CS), Lot Number  6560943 ;  Catalog Number SBAMHMFB16, UDI/DI 10197106321577 (EA)50197106321575 (CS), Lot Number  6560946 ;  Catalog Number SBAMHMFBH8, UDI/DI 10888439674149 (EA)50888439674147 (CS), Lot Number  J4952C  ;  Catalog Number SBAMHMFBH9, UDI/DI 10195594055929 (EA)50195594055927 (CS), Lot Number  J6367C  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J2977X  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J3987C  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J43U74  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J5679A  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J70X21  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J7704F  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  N/A     ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J53W72  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J7905F  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J7963D  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J84K04  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J85W24  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J8671P  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J8692Z  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  5631072 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  5891309 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  5891312 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  5891314 ; 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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-0908-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0908-2025&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0908-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0908-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-0908-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0908-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0908-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "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-0908-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0908-2025",
            "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": "Cardinal Health 200, LLC",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-11-08",
            "Status": "recorded"
          }
        },
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          "position": 8,
          "item": {
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 Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  5891312 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  J6367H  ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  5891313 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6022128 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6025791 ;  Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number  6345522 ;  Catalog Number SBA11CMCPD, UDI/DI 10888439548174 (EA)50888439548172 (CS), Lot Number  J3464F  ;  Catalog Number SBA11DPS10, UDI/DI 10195594317010 (EA)50195594317018 (CS), Lot Number  5478803 ;  Catalog Number SBA11DPS11, UDI/DI 10195594401580 (EA)50195594401588 (CS), Lot Number  5478803 ;  Catalog Number SBA11DPS12, UDI/DI 10195594541651 (EA)50195594541659 (CS), Lot Number  5888374 ;  Catalog Number SBA11DPS13, UDI/DI 10195594615192 (EA)50195594615190 (CS), Lot Number  5891311 ;  Catalog Number SBA11DPS14, UDI/DI 10195594676995 (EA)50195594676993 (CS), Lot Number  5891305 ;  Catalog Number SBA11DPS15, UDI/DI 10195594795788 (EA)50195594795786 (CS), Lot Number  6025787 ;  Catalog Number SBA11DPS16, UDI/DI 10195594885267 (EA)50195594885265 (CS), Lot Number  5631069 ;  Catalog Number SBA11DPS17, UDI/DI 10197106193761 (EA)50197106193769 (CS), Lot Number  6560944 ;  Catalog Number SBA11DPS18, UDI/DI 10197106320099 (EA)50197106320097 (CS), Lot Number  6701853 ;  Catalog Number SBA11DPS19, UDI/DI 10197106369456 (EA)50197106369454 (CS), Lot Number  6806113 ;  Catalog Number SBA11DPS20, UDI/DI 10197106507544 (EA)50197106507542 (CS), Lot Number  6928764 ;  Catalog Number SBA11DPS21, UDI/DI 10197106584798 (EA)50197106584796 (CS), Lot Number  7163104 ;  Catalog Number SBA11DPS22, UDI/DI 10197106769782 (EA)50197106769780 (CS), Lot Number  7280108 ;  Catalog Number SBA11DPSB4, UDI/DI 10888439689150 (EA)50888439689158 (CS), Lot Number  J53W67  ;  Catalog Number SBA11DPSB5, UDI/DI 10888439763836 (EA)50888439763834 (CS), Lot Number  J53W73  ;  Catalog Number SBA11DPSB6, UDI/DI 10888439995633 (EA)50888439995631 (CS), Lot Number  J8671M  ;  Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number  J9602T  ;  Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number  1933731664     ;  Catalog Number SBA11DPSB8, UDI/DI 10195594075415 (EA)50195594075413 (CS), Lot Number  5135984 ;  Catalog Number SBA11DPSB9, UDI/DI 10195594211462 (EA)50195594211460 (CS), Lot Number  5136018 ;  Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number  J34J43  ;  Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number  J46A99  ;  Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number  J70X20  ;  Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number  J8393U  ;  Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number  J8123Y  ;  Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number  J8671K  ;  Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number  J8692Z  ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6806114 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6928758 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  5631072 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  5891307 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  5891310 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  5631071 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  55693537       ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6264570 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6264566 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6264567 ;  Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number  6345523 ;  Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number  7280111 ;  Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number  7287567 ;  Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number  7332916 ;  Catalog Number SBA11MXCP1, UDI/DI 10195594114985 (EA)50195594114983 (CS), Lot Number  5140342 ;  Catalog Number SBA11MXCP2, UDI/DI 10195594347819 (EA)50195594347817 (CS), Lot Number  5478804 ;  Catalog Number SBA11MXCP3, UDI/DI 10195594366544 (EA)50195594366542 (CS), Lot Number  J6367F  ;  Catalog Number SBA11MXCP4, UDI/DI 10195594416027 (EA)50195594416025 (CS), Lot Number  5533336 ;  Catalog Number SBA11MXCP5, UDI/DI 10195594756369 (EA)50195594756367 (CS), Lot Number  6022131 ;  Catalog Number SBA11MXCP6, UDI/DI 10195594796587 (EA)50195594796585 (CS), Lot Number  6025787 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6563989 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  J86T81  ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6025787 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6264570 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6345522 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6487902 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6487902 ;  Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number  6487904 ;  Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number  6487901 ;  Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number  6596397 ;  Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number  6788562 ;  Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number  6928760 ;  Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number  6928760 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7332917 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7163033 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7163103 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7280107 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7332910 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7332906 ;  Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number  7332907 ;  Catalog Number SBA11PRH10, UDI/DI 10195594702298 (EA)50195594702296 (CS), Lot Number  5891314 ;  Catalog Number SBA11PRH11, UDI/DI 10195594765477 (EA)50195594765475 (CS), Lot Number  6025786 ;  Catalog Number SBA11PRH12, UDI/DI 10197106016053 (EA)50197106016051 (CS), Lot Number  6025791 ;  Catalog Number SBA11PRH13, UDI/DI 10197106100172 (EA)50197106100170 (CS), Lot Number  6345522 ;  Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number  157467  ;  Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number  22L3440 ;  Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number  6596396 ;  Catalog Number SBA11PRHK3, UDI/DI 10888439745429 (EA)50888439745427 (CS), Lot Number  J3464F  ;  Catalog Number SBA11PRHK4, UDI/DI 10888439947441 (EA)50888439947449 (CS), Lot Number  J8124A  ;  Catalog Number SBA11PRHK5, UDI/DI 10888439992335 (EA)50888439992333 (CS), Lot Number  J8692Y  ;  Catalog Number SBA11PRHK6, UDI/DI 10195594967062 (EA)50195594967060 (CS), Lot Number  J86T83  ;  Catalog Number SBA11PRHK7, UDI/DI 10195594464950 (EA)50195594464958 (CS), Lot Number  5631074 ;  Catalog Number SBA11PRHK8, UDI/DI 10195594542108 (EA)50195594542106 (CS), Lot Number  5888374 ;  Catalog Number SBA11PRHK9, UDI/DI 10195594659974 (EA)50195594659972 (CS), Lot Number  5891312 ;  Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number  J4952D  ;  Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number  J5679G  ;  Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number  J7704H  ;  Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number  J8123W  ;  Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number  J84K01  ;  Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number  5747232 ;  Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number  6806115 ;  Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number  6928766 ;  Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number  6928766 ;  Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number  6928769 ;  Catalog Number SBA11PRHKG, UDI/DI 10197106582015 (EA)50197106582013 (CS), Lot Number  7332917 ;  Catalog Number SBA11PRHKG, UDI/DI 10197106582015 (EA)50197106582013 (CS), Lot Number  7332909 ;  Catalog Number SBA12TR38C, UDI/DI 10887488792613 (EA)50887488792611 (CS), Lot Number  J3987C  ;  Catalog Number SBA12TR38C, UDI/DI 10887488792613 (EA)50887488792611 (CS), Lot Number  J4678G  ;  Catalog Number SBA13DSBW5, UDI/DI 10888439895087 (EA)50888439895085 (CS), Lot Number  J5679K  ;  Catalog Number SBA13DSBW6, UDI/DI 10195594078287 (EA)50195594078285 (CS), Lot Number  5135984 ;  Catalog Number SBA13DSBW7, UDI/DI 10195594128234 (EA)50195594128232 (CS), Lot Number  J6367C  ;  Catalog Number SBA13DSBW8, UDI/DI 10195594208615 (EA)50195594208613 (CS), Lot Number  5140342 ;  Catalog Number SBA13DSBW8, UDI/DI 10195594208615 (EA)50195594208613 (CS), Lot Number  5140354 ;  Catalog Number SBA13DSBWF, UDI/DI 10887488334868 (EA)50887488334866 (CS), Lot Number  J3464F  ;  Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number  J34J42  ;  Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number  J43U77  ;  Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number  J53W72  ;  Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number  J7963G  ;  Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number  J7963H  ;  Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number  J7905G  ;  Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number  J8123Z  ;  Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number  2003505164     ;  Catalog Number SBA13DSBWI, UDI/DI 10195594390129 (EA)50195594390127 (CS), Lot Number  5664102 ;  Catalog Number SBA13DSBWI, UDI/DI 10195594390129 (EA)50195594390127 (CS), Lot Number  5664101 ;  Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number  5891312 ;  Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number  5891314 ;  Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number  5891313 ;  Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number  6022131 ;  Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number  18B0346 ;  Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number  18K2934 ;  Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number  19A0125 ;  Catalog Number SBA13TCBCD, UDI/DI 10888439177909 (EA)50888439177907 (CS), Lot Number  J3464F  ;  Catalog Number SBA13TCBCD, UDI/DI 10888439177909 (EA)50888439177907 (CS), Lot Number  J4218Z  ;  Catalog Number SBA53FFK10, UDI/DI 10197106338612 (EA)50197106338610 (CS), Lot Number  6702010 ;  Catalog Number SBA53FFK11, UDI/DI 10197106494592 (EA)50197106494590 (CS), Lot Number  6928765 ;  Catalog Number SBA53FFK12, UDI/DI 10197106655085 (EA)50197106655083 (CS), Lot Number  7331342 ;  Catalog Number SBA53FFKH1, UDI/DI 10195594021399 (EA)50195594021397 (CS), Lot Number  J9602T  ;  Catalog Number SBA53FFKH2, UDI/DI 10195594042035 (EA)50195594042033 (CS), Lot Number  J8692W  ;  Catalog Number SBA53FFKH3, UDI/DI 10195594586843 (EA)50195594586841 (CS), Lot Number  5891309 ;  Catalog Number SBA53FFKH4, UDI/DI 10195594813390 (EA)50195594813398 (CS), Lot Number  5891315 ;  Catalog Number SBA53FFKH5, UDI/DI 10197106018569 (EA)50197106018567 (CS), Lot Number  6025791 ;  Catalog Number SBA53FFKH6, UDI/DI 10197106041987 (EA)50197106041985 (CS), Lot Number  6264570 ;  Catalog Number SBA53FFKH7, UDI/DI 10197106083475 (EA)50197106083473 (CS), Lot Number  6264569 ;  Catalog Number SBA53FFKH8, UDI/DI 10197106180280 (EA)50197106180288 (CS), Lot Number  6560945 ;  Catalog Number SBA53FFKH9, UDI/DI 10197106261156 (EA)50197106261154 (CS), Lot Number  6701852 ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  J7963H  ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  J8123W  ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  J84K01  ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  J8393W  ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  J8124A  ;  Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number  PO170874       ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  J8693A  ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  N/A     ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  J86T82  ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  J9849F  ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  5136018 ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  5618932 ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  5631074 ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  5891312 ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  5970334 ;  Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number  6025786 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332907 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332917 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  6596397 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  6928757 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  6928763 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7127056 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332904 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332914 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332916 ;  Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number  7332905 ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  J8671M  ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  J8692W  ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  5405626 ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  J6367F  ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  5664099 ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  5876883 ;  Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number  5891312 ;  Catalog Number SBA5DFGUMC, UDI/DI 10197106675984 (EA)50197106675982 (CS), Lot Number  7332910 ;  Catalog Number SBA5FSPMM5, UDI/DI 10195594918965 (EA)50195594918963 (CS), Lot Number  J8671P  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J3464F  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J34J41  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J46C02  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J4952D  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J53W68  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J46C03  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J5679A  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J7704G  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J8064Y  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J86T81  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J9602T  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  J6050H  ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5140342 ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5478803 ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5664099 ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5140345 ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5664103 ;  Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number  5891312 ;  Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number  7127056 ;  Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number  7280109 ;  Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number  7331342 ;  Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number  7332910 ;  Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number  7332912 ;  Catalog Number SBA60POLHB, UDI/DI 10197106730492 (EA)50197106730490 (CS), Lot Number  7332913 ;  Catalog Number SBA60POLHB, UDI/DI 10197106730492 (EA)50197106730490 (CS), Lot Number  7332918 ;  Catalog Number SBA73FFKO1, UDI/DI 10197106347904 (EA)50197106347902 (CS), Lot Number  6702012 ;  Catalog Number SBA73FFKOA, UDI/DI 10197106288252 (EA)50197106288250 (CS), Lot Number  7163103 ;  Catalog Number SBA73FFKOA, UDI/DI 10197106288252 (EA)50197106288250 (CS), Lot Number  6928771 ;  Catalog Number SBA73FFKWB, UDI/DI 10197106744550 (EA)50197106744558 (CS), Lot Number  7332915 ;  Catalog Number SBA73FFKWB, UDI/DI 10197106744550 (EA)50197106744558 (CS), Lot Number  7332908 ;  Catalog Number SBAMHMFB10, UDI/DI 10195594132552 (EA)50195594132550 (CS), Lot Number  J6050H  ;  Catalog Number SBAMHMFB11, UDI/DI 10195594249212 (EA)50195594249210 (CS), Lot Number  5140342 ;  Catalog Number SBAMHMFB12, UDI/DI 10195594393137 (EA)50195594393135 (CS), Lot Number  5533333 ;  Catalog Number SBAMHMFB13, UDI/DI 10195594520359 (EA)50195594520357 (CS), Lot Number  5140345 ;  Catalog Number SBAMHMFB14, UDI/DI 10195594546144 (EA)50195594546142 (CS), Lot Number  5876883 ;  Catalog Number SBAMHMFB15, UDI/DI 10197106118993 (EA)50197106118991 (CS), Lot Number  6560943 ;  Catalog Number SBAMHMFB16, UDI/DI 10197106321577 (EA)50197106321575 (CS), Lot Number  6560946 ;  Catalog Number SBAMHMFBH8, UDI/DI 10888439674149 (EA)50888439674147 (CS), Lot Number  J4952C  ;  Catalog Number SBAMHMFBH9, UDI/DI 10195594055929 (EA)50195594055927 (CS), Lot Number  J6367C  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J2977X  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J3987C  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J43U74  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J5679A  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J70X21  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J7704F  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  N/A     ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J53W72  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J7905F  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J7963D  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J84K04  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J85W24  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J8671P  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  J8692Z  ;  Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number  5631072 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  5891309 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  5891312 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  5891314 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  6025786 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  6025785 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  5631069 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  6264565 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  6025791 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  6264569 ;  Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number  6563988 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  33NFHD  ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  6563990 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  6022130 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  6806113 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  6914944 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  6596397 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  6914942 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  6928758 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  6928757 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  7163033 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  6928773 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  7163082 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  6928772 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  7332911 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  7332916 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  7332908 ;  Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number  7332907 ;  Catalog Number SEN11CMCP1, UDI/DI 10888439703269 (EA)50888439703267 (CS), Lot Number  J53W67  ;  Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number  J5679F  ;  Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number  J6050F  ;  Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number  J7963H  ;  Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number  J5679M  ;  Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number  J7905G  ;  Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number  J8393U  ;  Catalog Number SEN11CMCPB, UDI/DI 10888439941746 (EA)50888439941744 (CS), Lot Number  J85W23  ;  Catalog Number SEN11CMCPC, UDI/DI 10888439967500 (EA)50888439967508 (CS), Lot Number  J8692Y  ;  Catalog Number SEN11CMCPC, UDI/DI 10888439967500 (EA)50888439967508 (CS), Lot Number  J8693A  ;  Catalog Number SEN11ENN10, UDI/DI 10195594695897 (EA)50195594695895 (CS), Lot Number  6022064 ;  Catalog Number SEN11ENN11, UDI/DI 10195594745288 (EA)50195594745286 (CS), Lot Number  J6366P  ;  Catalog Number SEN11ENN12, UDI/DI 10195594780548 (EA)50195594780546 (CS), Lot Number  6279855 ;  Catalog Number SEN11ENN13, UDI/DI 10195594845643 (EA)50195594845641 (CS), Lot Number  6345507 ;  Catalog Number SEN11ENN14, UDI/DI 10197106019252 (EA)50197106019250 (CS), Lot Number  6487884 ;  Catalog Number SEN11ENN15, UDI/DI 10197106239278 (EA)50197106239276 (CS), Lot Number  6775018 ;  Catalog Number SEN11ENN16, UDI/DI 10197106321850 (EA)50197106321858 (CS), Lot Number  6701994 ;  Catalog Number SEN11ENNY4, UDI/DI 10888439725339 (EA)50888439725337 (CS), Lot Number  J53W33  ;  Catalog Number SEN11ENNY5, UDI/DI 10195594086879 (EA)50195594086877 (CS), Lot Number  5138318 ;  Catalog Number SEN11ENNY6, UDI/DI 10195594132033 (EA)50195594132031 (CS), Lot Number  5138317 ;  Catalog Number SEN11ENNY7, UDI/DI 10195594216238 (EA)50195594216236 (CS), Lot Number  J8670U  ;  Catalog Number SEN11ENNY8, UDI/DI 10195594322373 (EA)50195594322371 (CS), Lot Number  J6366M  ;  Catalog Number SEN11ENNY9, UDI/DI 10195594375355 (EA)50195594375353 (CS), Lot Number  5138322 ;  Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number  J30T23  ;  Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number  J46A87  ;  Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number  J2649N  ;  Catalog Number SEN11ENNYQ, UDI/DI",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}