{
  "@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-0916-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON    , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE   , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL  , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE  , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE  , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE    , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE    , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC5; 53) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC6; 54) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC7; 55) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC8; 56) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC9; 57) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCI; 58) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCJ; 59) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCK; 60) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCM; 61) KIT, SPINE   , Catalog Number: POHFSPMH1; 62) KIT, SPINE   , Catalog Number: POHFSPMH2; 63) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB10; 64) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB11; 65) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB12; 66) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB13; 67) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB14; 68) KIT,ORTHOPLAS",
  "description": "FDA recall Z-0916-2025 — Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON    , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE   , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL  , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE  , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE  , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE    , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE    , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC5; 53) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC6; 54) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC7; 55) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC8; 56) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC9; 57) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCI; 58) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCJ; 59) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCK; 60) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCM; 61) KIT, SPINE   , Catalog Number: POHFSPMH1; 62) KIT, SPINE   , Catalog Number: POHFSPMH2; 63) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB10; 64) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB11; 65) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB12; 66) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB13; 67) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB14; 68) KIT,ORTHOPLAS (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-0916-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON    , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE   , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL  , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE  , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE  , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE    , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE    , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC5; 53) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC6; 54) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC7; 55) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC8; 56) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC9; 57) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCI; 58) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCJ; 59) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCK; 60) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCM; 61) KIT, SPINE   , Catalog Number: POHFSPMH1; 62) KIT, SPINE   , Catalog Number: POHFSPMH2; 63) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB10; 64) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB11; 65) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB12; 66) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB13; 67) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB14; 68) KIT,ORTHOPLAS",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cardinal Health 200, LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0916-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0916-2025: Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON    , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE   , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL  , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE  , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE  , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE    , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE    , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC5; 53) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC6; 54) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC7; 55) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC8; 56) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC9; 57) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCI; 58) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCJ; 59) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCK; 60) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCM; 61) KIT, SPINE   , Catalog Number: POHFSPMH1; 62) KIT, SPINE   , Catalog Number: POHFSPMH2; 63) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB10; 64) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB11; 65) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB12; 66) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB13; 67) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB14; 68) KIT,ORTHOPLAS",
      "text": "The FDA logged enforcement record Z-0916-2025: Cardinal Health 200, LLC is voluntarily recalling Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON    , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE   , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL  , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE  , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE  , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE    , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE    , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE    , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC5; 53) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC6; 54) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC7; 55) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC8; 56) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC9; 57) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCI; 58) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCJ; 59) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCK; 60) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCM; 61) KIT, SPINE   , Catalog Number: POHFSPMH1; 62) KIT, SPINE   , Catalog Number: POHFSPMH2; 63) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB10; 64) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB11; 65) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB12; 66) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB13; 67) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB14; 68) KIT,ORTHOPLAS — 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 PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number  J34J41         ;  Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number  J43U77         ;  Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number  J4952G         ;  Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number  J53W73         ;  Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number  J4952H         ;  Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number  J6050F         ;  Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number  J74A27         ;  Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number  J7963D         ;  Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number  J7905F         ;  Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number  J84K02         ;  Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number  J8692Y         ;  Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number  J86T82         ;  Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number  20166041-3014  ;  Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number  5138318        ;  Catalog Number PN33MSOC3, UDI/DI 10197106660881 (EA)50197106660889 (CS), Lot Number  7331471        ;  Catalog Number PN33MSOCH, UDI/DI 10197106473498 (EA)50197106473496 (CS), Lot Number  7265882        ;  Catalog Number PN33MSOCH, UDI/DI 10197106473498 (EA)50197106473496 (CS), Lot Number  7280085        ;  Catalog Number PN33MSOCI, UDI/DI 10197106586525 (EA)50197106586523 (CS), Lot Number  7265980        ;  Catalog Number PN40LMBY6, UDI/DI 10195594059576 (EA)50195594059574 (CS), Lot Number  J9601U         ;  Catalog Number PN40LMBY6, UDI/DI 10195594059576 (EA)50195594059574 (CS), Lot Number  J96A01         ;  Catalog Number PN40LMBY7, UDI/DI 10195594163457 (EA)50195594163455 (CS), Lot Number  J9601W         ;  Catalog Number PN40LMBY7, UDI/DI 10195594163457 (EA)50195594163455 (CS), Lot Number  5138235        ;  Catalog Number PN40LMBY8, UDI/DI 10195594576653 (EA)50195594576651 (CS), Lot Number  J70X03         ;  Catalog Number PN40LMBY8, UDI/DI 10195594576653 (EA)50195594576651 (CS), Lot Number  5664035        ;  Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number  J30T23         ;  Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number  J4951J         ;  Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number  J53W36         ;  Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number  J7704A         ;  Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number  J4678M         ;  Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number  J4949U         ;  Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number  J6049W         ;  Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number  J79F27         ;  Catalog Number PN40LMBYE, UDI/DI 10888439959642 (EA)50888439959640 (CS), Lot Number  J7704A         ;  Catalog Number PN40LMBYE, UDI/DI 10888439959642 (EA)50888439959640 (CS), Lot Number  J6786F         ;  Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number  BCS725327015001;  Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number  5138322        ;  Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number  5530911        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7332852        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  6748343        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  6701994        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  6563921        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  6806107        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  6487885        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7265878        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7287503        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7280085        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7331468        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7331303        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7332852        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7102720        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  6264449        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  6986975        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7005435        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  6907766        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7122068        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7284052        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7280047        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7280048        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7287482        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7280050        ;  Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number  7332804        ;  Catalog Number PO40LMBY1, UDI/DI 10195594643676 (EA)50195594643674 (CS), Lot Number  5618930        ;  Catalog Number PO40LMBY1, UDI/DI 10195594643676 (EA)50195594643674 (CS), Lot Number  5891287        ;  Catalog Number PO40LMBY2, UDI/DI 10197106012901 (EA)50197106012909 (CS), Lot Number  6487884        ;  Catalog Number PO40LMBY2, UDI/DI 10197106012901 (EA)50197106012909 (CS), Lot Number  6485582        ;  Catalog Number PO40LMBY3, UDI/DI 10197106190494 (EA)50197106190492 (CS), Lot Number  6748342        ;  Catalog Number PO40LMBY3, UDI/DI 10197106190494 (EA)50197106190492 (CS), Lot Number  6264449        ;  Catalog Number PO40LMBY4, UDI/DI 10197106376102 (EA)50197106376100 (CS), Lot Number  6806107        ;  Catalog Number PO40LMBY4, UDI/DI 10197106376102 (EA)50197106376100 (CS), Lot Number  6701970        ;  Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number  7110268        ;  Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number  7265878        ;  Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number  7122068        ;  Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number  7287457        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7360338        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7332852        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6701996        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6775018        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6806107        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7265879        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7265977        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7265977        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7265977        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280085        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7331306        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7349669        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6701995        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6701994        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7045815        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280047        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6701942        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7058621        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7005446        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7286183        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280044        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280044        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280059        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280048        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7331284        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7332832        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6701957        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6568661        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6563990        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6487901        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6914944        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6928766        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6928764        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7127056        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7160537        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6928773        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7163104        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7280110        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7280109        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6928772        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7332910        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  2407826964     ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6928770        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6345524        ;  Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number  J4951J         ;  Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number  J4949R         ;  Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number  J4877G         ;  Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number  J79H44         ;  Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number  J7904N         ;  Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number  J8064U         ;  Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number  5775791        ;  Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number  J6049X         ;  Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number  5664045        ;  Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number  6279851        ;  Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number  6264450        ;  Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number  6345509        ;  Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number  6345507        ;  Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number  6485580        ;  Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number  6364783        ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J7498G         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J84J96         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J7704A         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J7609N         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J76N06         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J89H91         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J89C53         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J6785Z         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J70X09         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J8670W         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J86Y70         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J9601U         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J68T47         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J86N64         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J6910U         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J70X08         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J96N37         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J9699Z         ;  Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number  5631051        ;  Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number  5631025        ;  Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number  5533325        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  H2357570       ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  5918336        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  6701849        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  5891283        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  5775800        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  6687065        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  6470285        ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J30T19         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J30T21         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J2649N         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J43U69         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4951J         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4951N         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4219A         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J3986R         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J3986T         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4678U         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  N/A            ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J43U72         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4950G         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4877G         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4877H         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J53W13         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J46A80         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J7498G         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J7703Y         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J8393F         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J8123D         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J74A18         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J74A02         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J79F30         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J8045W         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J8392Y         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J8123J         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J6786C         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J86N64         ;  Catalog Number POHDOSWC1, UDI/DI 10197106017586 (EA)50197106017584 (CS), Lot Number  6487884        ;  Catalog Number POHDOSWC1, UDI/DI 10197106017586 (EA)50197106017584 (CS), Lot Number  6563795        ;  Catalog Number POHDOSWC2, UDI/DI 10197106157800 (EA)50197106157808 (CS), Lot Number  6748342        ;  Catalog Number POHDOSWC2, UDI/DI 10197106157800 (EA)50197106157808 (CS), Lot Number  6701966        ;  Catalog Number POHDOSWC3, UDI/DI 10197106342367 (EA)50197106342365 (CS), Lot Number  6987085        ;  Catalog Number POHDOSWC3, UDI/DI 10197106342367 (EA)50197106342365 (CS), Lot Number  7005445        ;  Catalog Number POHDOSWC4, UDI/DI 10197106414989 (EA)50197106414987 (CS), Lot Number  7005460        ;  Catalog Number POHDOSWC4, UDI/DI 10197106414989 (EA)50197106414987 (CS), Lot Number  7055825        ;  Catalog Number POHDOSWC5, UDI/DI 10197106485637 (EA)50197106485635 (CS), Lot Number  7110268        ;  Catalog Number POHDOSWC5, UDI/DI 10197106485637 (EA)50197106485635 (CS), Lot Number  7280114        ;  Catalog Number POHDOSWC6, UDI/DI 10197106497814 (EA)50197106497812 (CS), Lot Number  7265882        ;  Catalog Number POHDOSWC6, UDI/DI 10197106497814 (EA)50197106497812 (CS), Lot Number  7286184        ;  Catalog Number POHDOSWC7, UDI/DI 10197106559611 (EA)50197106559619 (CS), Lot Number  7265884        ;  Catalog Number POHDOSWC7, UDI/DI 10197106559611 (EA)50197106559619 (CS), Lot Number  7280056        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  6775015        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  7265882        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  7265883        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  6905475        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  7160480        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  7280036        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7332852        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7265883        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7287505        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7331468        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7332854        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7331306        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7332854        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7349669        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7102719        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7280044        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7287460        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7287481        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7332803        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7332806        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  6560925        ;  Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number  5565992        ;  Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number  5405612        ;  Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number  5405617        ;  Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number  5508060        ;  Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number  5138323        ;  Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number  5631028        ;  Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number  5533307        ;  Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number  5478805        ;  Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number  J65K10         ;  Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number  5664019        ;  Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number  5508054        ;  Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number  5664107        ;  Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number  5775791        ;  Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number  J6049X         ;  Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number  5508051        ;  Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number  5664107        ;  Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number  6279851        ;  Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number  6025760        ;  Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number  6232007        ;  Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number  6133661        ;  Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number  6169295        ;  Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number  6345500        ;  Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number  6022071        ;  Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number  6264574        ;  Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number  6411419        ;  Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number  6485577        ;  Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number  6345510        ;  Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number  202109016-KSH  ;  Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number  6345526        ;  Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number  6487889        ;  Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number  6560930        ;  Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number  6498134        ;  Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number  6345527        ;  Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number  6487888        ;  Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number  6025767        ;  Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number  6470296        ;  Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number  6702023        ;  Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number  J4219N         ;  Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number  J37T60         ;  Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number  J4219T         ;  Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number  J37U15         ;  Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number  J4951H         ;  Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number  J53W05         ;  Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number  J4877M         ;  Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number  J4952U         ;  Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number  J5677Z         ;  Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number  N/A            ;  Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number  J6049T         ;  Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number  J6278J         ;  Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number  J43U79         ;  Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number  J5678C         ;  Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number  J76N04         ;  Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number  J7904X         ;  Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number  J76D61         ;  Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number  J79H47         ;  Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number  J82K98         ; 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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-0916-2025&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-0916-2025&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-0916-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0916-2025 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-0916-2025&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-0916-2025&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-0916-2025/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."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-0916-2025",
      "numberOfItems": 9,
      "itemListElement": [
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0916-2025",
            "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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 Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number  7265878        ;  Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number  7122068        ;  Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number  7287457        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7360338        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7332852        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6701996        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6775018        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6806107        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7265879        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7265977        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7265977        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7265977        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280085        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7331306        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7349669        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6701995        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6701994        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7045815        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280047        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6701942        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7058621        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7005446        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7286183        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280044        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280044        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280059        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7280048        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7331284        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  7332832        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6701957        ;  Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number  6568661        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6563990        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6487901        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6914944        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6928766        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6928764        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7127056        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7160537        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6928773        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7163104        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7280110        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7280109        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6928772        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  7332910        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  2407826964     ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6928770        ;  Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number  6345524        ;  Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number  J4951J         ;  Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number  J4949R         ;  Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number  J4877G         ;  Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number  J79H44         ;  Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number  J7904N         ;  Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number  J8064U         ;  Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number  5775791        ;  Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number  J6049X         ;  Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number  5664045        ;  Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number  6279851        ;  Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number  6264450        ;  Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number  6345509        ;  Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number  6345507        ;  Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number  6485580        ;  Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number  6364783        ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J7498G         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J84J96         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J7704A         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J7609N         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J76N06         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J89H91         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J89C53         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J6785Z         ;  Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number  J70X09         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J8670W         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J86Y70         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J9601U         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J68T47         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J86N64         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J6910U         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J70X08         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J96N37         ;  Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number  J9699Z         ;  Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number  5631051        ;  Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number  5631025        ;  Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number  5533325        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  H2357570       ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  5918336        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  6701849        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  5891283        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  5775800        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  6687065        ;  Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number  6470285        ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J30T19         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J30T21         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J2649N         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J43U69         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4951J         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4951N         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4219A         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J3986R         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J3986T         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4678U         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  N/A            ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J43U72         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4950G         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4877G         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J4877H         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J53W13         ;  Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number  J46A80         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J7498G         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J7703Y         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J8393F         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J8123D         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J74A18         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J74A02         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J79F30         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J8045W         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J8392Y         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J8123J         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J6786C         ;  Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number  J86N64         ;  Catalog Number POHDOSWC1, UDI/DI 10197106017586 (EA)50197106017584 (CS), Lot Number  6487884        ;  Catalog Number POHDOSWC1, UDI/DI 10197106017586 (EA)50197106017584 (CS), Lot Number  6563795        ;  Catalog Number POHDOSWC2, UDI/DI 10197106157800 (EA)50197106157808 (CS), Lot Number  6748342        ;  Catalog Number POHDOSWC2, UDI/DI 10197106157800 (EA)50197106157808 (CS), Lot Number  6701966        ;  Catalog Number POHDOSWC3, UDI/DI 10197106342367 (EA)50197106342365 (CS), Lot Number  6987085        ;  Catalog Number POHDOSWC3, UDI/DI 10197106342367 (EA)50197106342365 (CS), Lot Number  7005445        ;  Catalog Number POHDOSWC4, UDI/DI 10197106414989 (EA)50197106414987 (CS), Lot Number  7005460        ;  Catalog Number POHDOSWC4, UDI/DI 10197106414989 (EA)50197106414987 (CS), Lot Number  7055825        ;  Catalog Number POHDOSWC5, UDI/DI 10197106485637 (EA)50197106485635 (CS), Lot Number  7110268        ;  Catalog Number POHDOSWC5, UDI/DI 10197106485637 (EA)50197106485635 (CS), Lot Number  7280114        ;  Catalog Number POHDOSWC6, UDI/DI 10197106497814 (EA)50197106497812 (CS), Lot Number  7265882        ;  Catalog Number POHDOSWC6, UDI/DI 10197106497814 (EA)50197106497812 (CS), Lot Number  7286184        ;  Catalog Number POHDOSWC7, UDI/DI 10197106559611 (EA)50197106559619 (CS), Lot Number  7265884        ;  Catalog Number POHDOSWC7, UDI/DI 10197106559611 (EA)50197106559619 (CS), Lot Number  7280056        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  6775015        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  7265882        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  7265883        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  6905475        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  7160480        ;  Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number  7280036        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7332852        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7265883        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7287505        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7331468        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7332854        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7331306        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7332854        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7349669        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7102719        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7280044        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7287460        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7287481        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7332803        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  7332806        ;  Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number  6560925        ;  Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number  5565992        ;  Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number  5405612        ;  Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number  5405617        ;  Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number  5508060        ;  Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number  5138323        ;  Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number  5631028        ;  Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number  5533307        ;  Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number  5478805        ;  Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number  J65K10         ;  Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number  5664019        ;  Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number  5508054        ;  Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number  5664107        ;  Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number  5775791        ;  Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number  J6049X         ;  Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number  5508051        ;  Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number  5664107        ;  Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number  6279851        ;  Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number  6025760        ;  Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number  6232007        ;  Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number  6133661        ;  Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number  6169295        ;  Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number  6345500        ;  Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number  6022071        ;  Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number  6264574        ;  Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number  6411419        ;  Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number  6485577        ;  Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number  6345510        ;  Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number  202109016-KSH  ;  Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number  6345526        ;  Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number  6487889        ;  Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number  6560930        ;  Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number  6498134        ;  Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number  6345527        ;  Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number  6487888        ;  Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number  6025767        ;  Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number  6470296        ;  Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number  6702023        ;  Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number  J4219N         ;  Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number  J37T60         ;  Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number  J4219T         ;  Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number  J37U15         ;  Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number  J4951H         ;  Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number  J53W05         ;  Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number  J4877M         ;  Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number  J4952U         ;  Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number  J5677Z         ;  Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number  N/A            ;  Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number  J6049T         ;  Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number  J6278J         ;  Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number  J43U79         ;  Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number  J5678C         ;  Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number  J76N04         ;  Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number  J7904X         ;  Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number  J76D61         ;  Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number  J79H47         ;  Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number  J82K98         ;  Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number  J8064U         ;  Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number  J7963X         ;  Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number  J84J96         ;  Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number  5136036        ;  Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number  5136012        ;  Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number  J9850D         ;  Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number  J6278F         ;  Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number  5311244        ;  Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number  5138330        ;  Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number  5140378        ;  Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number  J8393F         ;  Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number  J8670J         ;  Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number  J86N65         ;  Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number  J85W31         ;  Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number  J84J96         ;  Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number  J8670Z         ;  Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number  J6910P         ;  Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number  J70X09         ;  Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number  J9424H         ;  Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number  J6368Z         ;  Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number  J96N36         ;  Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number  J9424M         ;  Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number  J6368U         ;  Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number  J9601W         ;  Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number  5405610        ;  Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number  5508050        ;  Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number  5508060        ;  Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number  5533338        ;  Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number  5775794        ;  Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number  6487884        ;  Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number  5664021        ;  Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number  5891301        ;  Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number  5970335        ;  Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number  6563795        ;  Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number  6416684        ;  Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number  6487906        ;  Catalog Number POHFSPMH1, UDI/DI 10888439747515 (EA)",
            "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"
          }
        }
      ]
    }
  ]
}