{
  "@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-3051-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) ADULT DRAWER 5, Pack Number ACC010647A ;  2) TUBAL LIGATION CDS, Pack Number CDS760053K ;  3) CATARACT CDS, Pack Number CDS810010J ;  4) CATARACT CDS, Pack Number CDS810010K ;  5) RETINA-LF, Pack Number CDS810023G;  6) RETINA-LF, Pack Number CDS810023I;  7) RETINA-LF, Pack Number CDS810023J;  8) RETINA-LF, Pack Number CDS810023K;  9) EYE CDS , Pack Number CDS810032L ;  10) EYE CDS , Pack Number CDS810032M ;  11) EYE CDS , Pack Number CDS810032N ;  12) EYE CDS , Pack Number CDS810032O ;  13) GENERAL EYE , Pack Number CDS981693I ;  14) GENERAL EYE , Pack Number CDS981693J ;  15) EYE CDS II, Pack Number CDS981738A ;  16) MUSCLE/EYE CDS, Pack Number CDS982059F ;  17) MUSCLE/EYE CDS, Pack Number CDS982059G ;  18) MUSCLE/EYE CDS, Pack Number CDS982059I ;  19) CATARACT CDS-4, Pack Number CDS983001F ;  20) VITRECTOMY CDS-4, Pack Number CDS983005F ;  21) PTERYGIUM CDS , Pack Number CDS983261D ;  22) PTERYGIUM CDS , Pack Number CDS983261F ;  23) PTERYGIUM CDS , Pack Number CDS983261G ;  24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ;  25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ;  26) RETINA LAC/USC CDS, Pack Number CDS983775I;  27) EYE CDS , Pack Number CDS983916F ;  28) EYE CDS , Pack Number CDS983916G ;  29) CATH CDS, Pack Number CDS984141G ;  30) CATARACT CDS, Pack Number CDS984159C ;  31) CATARACT CDS, Pack Number CDS984159D ;  32) CATARACT CDS, Pack Number CDS984159G ;  33) CATARACT CDS, Pack Number CDS984159I ;  34) VITRECTOMY, Pack Number CDS984258J ;  35) VITRECTOMY, Pack Number CDS984258K ;  36) VITRECTOMY, Pack Number CDS984258L ;  37) CATARACT CDS, Pack Number CDS984343B ;  38) CATARACT CDS, Pack Number CDS984343C ;  39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ;  40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH;  41) EYE BANK PREP KIT , Pack Number DYNDA2345;  42) LASIK PACK, Pack Number DYNDA2925;  43) EYE PLASTIC KIT, Pack Number DYNDC3196;  44) BIOPSY TRAY , Pack Number DYNDH1854;  45) LACERATION TRAY , Pack Number DYNDL1990;  46) LASIK PACK, Pack Number DYNDM1087;  47) GLENNON EYE PACK, Pack Number DYNJ00098F ;  48) CATARACT PACK , Pack Number DYNJ00260K ;  49) INTRAOCULAR PACK, Pack Number DYNJ00260L ;  50) INTRAOCULAR PACK, Pack Number DYNJ00260M ;  51) EYEPACK , Pack Number DYNJ00874G ;  52) EYEPACK , Pack Number DYNJ00874I ;  53) EYEPACK , Pack Number DYNJ00874J ;  54) EYEPACK , Pack Number DYNJ00874K ;  55) MEC EYE PACK, Pack Number DYNJ0101578F ;  56) MEC EYE PACK, Pack Number DYNJ0101578G ;  57) MEC EYE PACK, Pack Number DYNJ0101578J ;  58) BR EYE PAC, Pack Number DYNJ0101578K ;  59) BR EYE PACK-LF, Pack Number DYNJ0101578L ;  60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ;  61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ;  62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ;  63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ;  64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ;  65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ;  66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ;  67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ;  68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ;  69) CATARACT PACK , Pack Number DYNJ01263G ;  70) CATARACT PACK , Pack Number DYNJ01263I ;  71) CATARACT PACK , Pack Number DYNJ01263J ;  72) CATARACT PACK-LF, Pack Number DYNJ0129784R ;  73) CATARACT PACK-LF, Pack Number DYNJ0129784RH;  74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ;  75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ;  76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ;  77) RETINAL PACK-LF , Pack Number DYNJ0151148B ;  78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ;  79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ;  80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ;  81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ;  82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ;  83) CATARACT PACK-LF, Pack Number DYNJ0159809B ;  84) EYE PACK, Pack Number DYNJ0168810Q ;  85) EYE PBM-LF, Pack Number DYNJ0190619F ;  86) EYE PBM-LF, Pack Num",
  "description": "FDA recall Z-3051-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) ADULT DRAWER 5, Pack Number ACC010647A ;  2) TUBAL LIGATION CDS, Pack Number CDS760053K ;  3) CATARACT CDS, Pack Number CDS810010J ;  4) CATARACT CDS, Pack Number CDS810010K ;  5) RETINA-LF, Pack Number CDS810023G;  6) RETINA-LF, Pack Number CDS810023I;  7) RETINA-LF, Pack Number CDS810023J;  8) RETINA-LF, Pack Number CDS810023K;  9) EYE CDS , Pack Number CDS810032L ;  10) EYE CDS , Pack Number CDS810032M ;  11) EYE CDS , Pack Number CDS810032N ;  12) EYE CDS , Pack Number CDS810032O ;  13) GENERAL EYE , Pack Number CDS981693I ;  14) GENERAL EYE , Pack Number CDS981693J ;  15) EYE CDS II, Pack Number CDS981738A ;  16) MUSCLE/EYE CDS, Pack Number CDS982059F ;  17) MUSCLE/EYE CDS, Pack Number CDS982059G ;  18) MUSCLE/EYE CDS, Pack Number CDS982059I ;  19) CATARACT CDS-4, Pack Number CDS983001F ;  20) VITRECTOMY CDS-4, Pack Number CDS983005F ;  21) PTERYGIUM CDS , Pack Number CDS983261D ;  22) PTERYGIUM CDS , Pack Number CDS983261F ;  23) PTERYGIUM CDS , Pack Number CDS983261G ;  24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ;  25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ;  26) RETINA LAC/USC CDS, Pack Number CDS983775I;  27) EYE CDS , Pack Number CDS983916F ;  28) EYE CDS , Pack Number CDS983916G ;  29) CATH CDS, Pack Number CDS984141G ;  30) CATARACT CDS, Pack Number CDS984159C ;  31) CATARACT CDS, Pack Number CDS984159D ;  32) CATARACT CDS, Pack Number CDS984159G ;  33) CATARACT CDS, Pack Number CDS984159I ;  34) VITRECTOMY, Pack Number CDS984258J ;  35) VITRECTOMY, Pack Number CDS984258K ;  36) VITRECTOMY, Pack Number CDS984258L ;  37) CATARACT CDS, Pack Number CDS984343B ;  38) CATARACT CDS, Pack Number CDS984343C ;  39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ;  40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH;  41) EYE BANK PREP KIT , Pack Number DYNDA2345;  42) LASIK PACK, Pack Number DYNDA2925;  43) EYE PLASTIC KIT, Pack Number DYNDC3196;  44) BIOPSY TRAY , Pack Number DYNDH1854;  45) LACERATION TRAY , Pack Number DYNDL1990;  46) LASIK PACK, Pack Number DYNDM1087;  47) GLENNON EYE PACK, Pack Number DYNJ00098F ;  48) CATARACT PACK , Pack Number DYNJ00260K ;  49) INTRAOCULAR PACK, Pack Number DYNJ00260L ;  50) INTRAOCULAR PACK, Pack Number DYNJ00260M ;  51) EYEPACK , Pack Number DYNJ00874G ;  52) EYEPACK , Pack Number DYNJ00874I ;  53) EYEPACK , Pack Number DYNJ00874J ;  54) EYEPACK , Pack Number DYNJ00874K ;  55) MEC EYE PACK, Pack Number DYNJ0101578F ;  56) MEC EYE PACK, Pack Number DYNJ0101578G ;  57) MEC EYE PACK, Pack Number DYNJ0101578J ;  58) BR EYE PAC, Pack Number DYNJ0101578K ;  59) BR EYE PACK-LF, Pack Number DYNJ0101578L ;  60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ;  61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ;  62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ;  63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ;  64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ;  65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ;  66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ;  67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ;  68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ;  69) CATARACT PACK , Pack Number DYNJ01263G ;  70) CATARACT PACK , Pack Number DYNJ01263I ;  71) CATARACT PACK , Pack Number DYNJ01263J ;  72) CATARACT PACK-LF, Pack Number DYNJ0129784R ;  73) CATARACT PACK-LF, Pack Number DYNJ0129784RH;  74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ;  75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ;  76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ;  77) RETINAL PACK-LF , Pack Number DYNJ0151148B ;  78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ;  79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ;  80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ;  81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ;  82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ;  83) CATARACT PACK-LF, Pack Number DYNJ0159809B ;  84) EYE PACK, Pack Number DYNJ0168810Q ;  85) EYE PBM-LF, Pack Number DYNJ0190619F ;  86) EYE PBM-LF, Pack Num (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-3051-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) ADULT DRAWER 5, Pack Number ACC010647A ;  2) TUBAL LIGATION CDS, Pack Number CDS760053K ;  3) CATARACT CDS, Pack Number CDS810010J ;  4) CATARACT CDS, Pack Number CDS810010K ;  5) RETINA-LF, Pack Number CDS810023G;  6) RETINA-LF, Pack Number CDS810023I;  7) RETINA-LF, Pack Number CDS810023J;  8) RETINA-LF, Pack Number CDS810023K;  9) EYE CDS , Pack Number CDS810032L ;  10) EYE CDS , Pack Number CDS810032M ;  11) EYE CDS , Pack Number CDS810032N ;  12) EYE CDS , Pack Number CDS810032O ;  13) GENERAL EYE , Pack Number CDS981693I ;  14) GENERAL EYE , Pack Number CDS981693J ;  15) EYE CDS II, Pack Number CDS981738A ;  16) MUSCLE/EYE CDS, Pack Number CDS982059F ;  17) MUSCLE/EYE CDS, Pack Number CDS982059G ;  18) MUSCLE/EYE CDS, Pack Number CDS982059I ;  19) CATARACT CDS-4, Pack Number CDS983001F ;  20) VITRECTOMY CDS-4, Pack Number CDS983005F ;  21) PTERYGIUM CDS , Pack Number CDS983261D ;  22) PTERYGIUM CDS , Pack Number CDS983261F ;  23) PTERYGIUM CDS , Pack Number CDS983261G ;  24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ;  25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ;  26) RETINA LAC/USC CDS, Pack Number CDS983775I;  27) EYE CDS , Pack Number CDS983916F ;  28) EYE CDS , Pack Number CDS983916G ;  29) CATH CDS, Pack Number CDS984141G ;  30) CATARACT CDS, Pack Number CDS984159C ;  31) CATARACT CDS, Pack Number CDS984159D ;  32) CATARACT CDS, Pack Number CDS984159G ;  33) CATARACT CDS, Pack Number CDS984159I ;  34) VITRECTOMY, Pack Number CDS984258J ;  35) VITRECTOMY, Pack Number CDS984258K ;  36) VITRECTOMY, Pack Number CDS984258L ;  37) CATARACT CDS, Pack Number CDS984343B ;  38) CATARACT CDS, Pack Number CDS984343C ;  39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ;  40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH;  41) EYE BANK PREP KIT , Pack Number DYNDA2345;  42) LASIK PACK, Pack Number DYNDA2925;  43) EYE PLASTIC KIT, Pack Number DYNDC3196;  44) BIOPSY TRAY , Pack Number DYNDH1854;  45) LACERATION TRAY , Pack Number DYNDL1990;  46) LASIK PACK, Pack Number DYNDM1087;  47) GLENNON EYE PACK, Pack Number DYNJ00098F ;  48) CATARACT PACK , Pack Number DYNJ00260K ;  49) INTRAOCULAR PACK, Pack Number DYNJ00260L ;  50) INTRAOCULAR PACK, Pack Number DYNJ00260M ;  51) EYEPACK , Pack Number DYNJ00874G ;  52) EYEPACK , Pack Number DYNJ00874I ;  53) EYEPACK , Pack Number DYNJ00874J ;  54) EYEPACK , Pack Number DYNJ00874K ;  55) MEC EYE PACK, Pack Number DYNJ0101578F ;  56) MEC EYE PACK, Pack Number DYNJ0101578G ;  57) MEC EYE PACK, Pack Number DYNJ0101578J ;  58) BR EYE PAC, Pack Number DYNJ0101578K ;  59) BR EYE PACK-LF, Pack Number DYNJ0101578L ;  60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ;  61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ;  62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ;  63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ;  64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ;  65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ;  66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ;  67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ;  68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ;  69) CATARACT PACK , Pack Number DYNJ01263G ;  70) CATARACT PACK , Pack Number DYNJ01263I ;  71) CATARACT PACK , Pack Number DYNJ01263J ;  72) CATARACT PACK-LF, Pack Number DYNJ0129784R ;  73) CATARACT PACK-LF, Pack Number DYNJ0129784RH;  74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ;  75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ;  76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ;  77) RETINAL PACK-LF , Pack Number DYNJ0151148B ;  78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ;  79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ;  80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ;  81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ;  82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ;  83) CATARACT PACK-LF, Pack Number DYNJ0159809B ;  84) EYE PACK, Pack Number DYNJ0168810Q ;  85) EYE PBM-LF, Pack Number DYNJ0190619F ;  86) EYE PBM-LF, Pack Num",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3051-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3051-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) ADULT DRAWER 5, Pack Number ACC010647A ;  2) TUBAL LIGATION CDS, Pack Number CDS760053K ;  3) CATARACT CDS, Pack Number CDS810010J ;  4) CATARACT CDS, Pack Number CDS810010K ;  5) RETINA-LF, Pack Number CDS810023G;  6) RETINA-LF, Pack Number CDS810023I;  7) RETINA-LF, Pack Number CDS810023J;  8) RETINA-LF, Pack Number CDS810023K;  9) EYE CDS , Pack Number CDS810032L ;  10) EYE CDS , Pack Number CDS810032M ;  11) EYE CDS , Pack Number CDS810032N ;  12) EYE CDS , Pack Number CDS810032O ;  13) GENERAL EYE , Pack Number CDS981693I ;  14) GENERAL EYE , Pack Number CDS981693J ;  15) EYE CDS II, Pack Number CDS981738A ;  16) MUSCLE/EYE CDS, Pack Number CDS982059F ;  17) MUSCLE/EYE CDS, Pack Number CDS982059G ;  18) MUSCLE/EYE CDS, Pack Number CDS982059I ;  19) CATARACT CDS-4, Pack Number CDS983001F ;  20) VITRECTOMY CDS-4, Pack Number CDS983005F ;  21) PTERYGIUM CDS , Pack Number CDS983261D ;  22) PTERYGIUM CDS , Pack Number CDS983261F ;  23) PTERYGIUM CDS , Pack Number CDS983261G ;  24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ;  25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ;  26) RETINA LAC/USC CDS, Pack Number CDS983775I;  27) EYE CDS , Pack Number CDS983916F ;  28) EYE CDS , Pack Number CDS983916G ;  29) CATH CDS, Pack Number CDS984141G ;  30) CATARACT CDS, Pack Number CDS984159C ;  31) CATARACT CDS, Pack Number CDS984159D ;  32) CATARACT CDS, Pack Number CDS984159G ;  33) CATARACT CDS, Pack Number CDS984159I ;  34) VITRECTOMY, Pack Number CDS984258J ;  35) VITRECTOMY, Pack Number CDS984258K ;  36) VITRECTOMY, Pack Number CDS984258L ;  37) CATARACT CDS, Pack Number CDS984343B ;  38) CATARACT CDS, Pack Number CDS984343C ;  39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ;  40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH;  41) EYE BANK PREP KIT , Pack Number DYNDA2345;  42) LASIK PACK, Pack Number DYNDA2925;  43) EYE PLASTIC KIT, Pack Number DYNDC3196;  44) BIOPSY TRAY , Pack Number DYNDH1854;  45) LACERATION TRAY , Pack Number DYNDL1990;  46) LASIK PACK, Pack Number DYNDM1087;  47) GLENNON EYE PACK, Pack Number DYNJ00098F ;  48) CATARACT PACK , Pack Number DYNJ00260K ;  49) INTRAOCULAR PACK, Pack Number DYNJ00260L ;  50) INTRAOCULAR PACK, Pack Number DYNJ00260M ;  51) EYEPACK , Pack Number DYNJ00874G ;  52) EYEPACK , Pack Number DYNJ00874I ;  53) EYEPACK , Pack Number DYNJ00874J ;  54) EYEPACK , Pack Number DYNJ00874K ;  55) MEC EYE PACK, Pack Number DYNJ0101578F ;  56) MEC EYE PACK, Pack Number DYNJ0101578G ;  57) MEC EYE PACK, Pack Number DYNJ0101578J ;  58) BR EYE PAC, Pack Number DYNJ0101578K ;  59) BR EYE PACK-LF, Pack Number DYNJ0101578L ;  60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ;  61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ;  62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ;  63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ;  64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ;  65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ;  66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ;  67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ;  68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ;  69) CATARACT PACK , Pack Number DYNJ01263G ;  70) CATARACT PACK , Pack Number DYNJ01263I ;  71) CATARACT PACK , Pack Number DYNJ01263J ;  72) CATARACT PACK-LF, Pack Number DYNJ0129784R ;  73) CATARACT PACK-LF, Pack Number DYNJ0129784RH;  74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ;  75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ;  76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ;  77) RETINAL PACK-LF , Pack Number DYNJ0151148B ;  78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ;  79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ;  80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ;  81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ;  82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ;  83) CATARACT PACK-LF, Pack Number DYNJ0159809B ;  84) EYE PACK, Pack Number DYNJ0168810Q ;  85) EYE PBM-LF, Pack Number DYNJ0190619F ;  86) EYE PBM-LF, Pack Num",
      "text": "The FDA logged enforcement record Z-3051-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) ADULT DRAWER 5, Pack Number ACC010647A ;  2) TUBAL LIGATION CDS, Pack Number CDS760053K ;  3) CATARACT CDS, Pack Number CDS810010J ;  4) CATARACT CDS, Pack Number CDS810010K ;  5) RETINA-LF, Pack Number CDS810023G;  6) RETINA-LF, Pack Number CDS810023I;  7) RETINA-LF, Pack Number CDS810023J;  8) RETINA-LF, Pack Number CDS810023K;  9) EYE CDS , Pack Number CDS810032L ;  10) EYE CDS , Pack Number CDS810032M ;  11) EYE CDS , Pack Number CDS810032N ;  12) EYE CDS , Pack Number CDS810032O ;  13) GENERAL EYE , Pack Number CDS981693I ;  14) GENERAL EYE , Pack Number CDS981693J ;  15) EYE CDS II, Pack Number CDS981738A ;  16) MUSCLE/EYE CDS, Pack Number CDS982059F ;  17) MUSCLE/EYE CDS, Pack Number CDS982059G ;  18) MUSCLE/EYE CDS, Pack Number CDS982059I ;  19) CATARACT CDS-4, Pack Number CDS983001F ;  20) VITRECTOMY CDS-4, Pack Number CDS983005F ;  21) PTERYGIUM CDS , Pack Number CDS983261D ;  22) PTERYGIUM CDS , Pack Number CDS983261F ;  23) PTERYGIUM CDS , Pack Number CDS983261G ;  24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ;  25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ;  26) RETINA LAC/USC CDS, Pack Number CDS983775I;  27) EYE CDS , Pack Number CDS983916F ;  28) EYE CDS , Pack Number CDS983916G ;  29) CATH CDS, Pack Number CDS984141G ;  30) CATARACT CDS, Pack Number CDS984159C ;  31) CATARACT CDS, Pack Number CDS984159D ;  32) CATARACT CDS, Pack Number CDS984159G ;  33) CATARACT CDS, Pack Number CDS984159I ;  34) VITRECTOMY, Pack Number CDS984258J ;  35) VITRECTOMY, Pack Number CDS984258K ;  36) VITRECTOMY, Pack Number CDS984258L ;  37) CATARACT CDS, Pack Number CDS984343B ;  38) CATARACT CDS, Pack Number CDS984343C ;  39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ;  40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH;  41) EYE BANK PREP KIT , Pack Number DYNDA2345;  42) LASIK PACK, Pack Number DYNDA2925;  43) EYE PLASTIC KIT, Pack Number DYNDC3196;  44) BIOPSY TRAY , Pack Number DYNDH1854;  45) LACERATION TRAY , Pack Number DYNDL1990;  46) LASIK PACK, Pack Number DYNDM1087;  47) GLENNON EYE PACK, Pack Number DYNJ00098F ;  48) CATARACT PACK , Pack Number DYNJ00260K ;  49) INTRAOCULAR PACK, Pack Number DYNJ00260L ;  50) INTRAOCULAR PACK, Pack Number DYNJ00260M ;  51) EYEPACK , Pack Number DYNJ00874G ;  52) EYEPACK , Pack Number DYNJ00874I ;  53) EYEPACK , Pack Number DYNJ00874J ;  54) EYEPACK , Pack Number DYNJ00874K ;  55) MEC EYE PACK, Pack Number DYNJ0101578F ;  56) MEC EYE PACK, Pack Number DYNJ0101578G ;  57) MEC EYE PACK, Pack Number DYNJ0101578J ;  58) BR EYE PAC, Pack Number DYNJ0101578K ;  59) BR EYE PACK-LF, Pack Number DYNJ0101578L ;  60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ;  61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ;  62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ;  63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ;  64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ;  65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ;  66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ;  67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ;  68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ;  69) CATARACT PACK , Pack Number DYNJ01263G ;  70) CATARACT PACK , Pack Number DYNJ01263I ;  71) CATARACT PACK , Pack Number DYNJ01263J ;  72) CATARACT PACK-LF, Pack Number DYNJ0129784R ;  73) CATARACT PACK-LF, Pack Number DYNJ0129784RH;  74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ;  75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ;  76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ;  77) RETINAL PACK-LF , Pack Number DYNJ0151148B ;  78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ;  79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ;  80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ;  81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ;  82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ;  83) CATARACT PACK-LF, Pack Number DYNJ0159809B ;  84) EYE PACK, Pack Number DYNJ0168810Q ;  85) EYE PBM-LF, Pack Number DYNJ0190619F ;  86) EYE PBM-LF, Pack Num — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: ACC010647A , Lot Number 23CDC070 ;  ACC010647A , Lot Number 23DDA683 ;  CDS760053K , Lot Number 22HBP517 ;  CDS760053K , Lot Number 22HBS797 ;  CDS760053K , Lot Number 22LBS190 ;  CDS760053K , Lot Number 23ABC154 ;  CDS760053K , Lot Number 23ABM789 ;  CDS760053K , Lot Number 23EBB486 ;  CDS760053K , Lot Number 23IBP664 ;  CDS810010J , Lot Number 19BBU744 ;  CDS810010J , Lot Number 19DBL815 ;  CDS810010J , Lot Number 19FBH859 ;  CDS810010J , Lot Number 19HBO222 ;  CDS810010J , Lot Number 19IBG752 ;  CDS810010J , Lot Number 20BBT732 ;  CDS810010J , Lot Number 20CBY376 ;  CDS810010J , Lot Number 20EBA044 ;  CDS810010J , Lot Number 20FBF639 ;  CDS810010J , Lot Number 21DBT774 ;  CDS810010K , Lot Number 21IBI534 ;  CDS810010K , Lot Number 21JBM642 ;  CDS810010K , Lot Number 21KBT225 ;  CDS810010K , Lot Number 21KBY732 ;  CDS810010K , Lot Number 21LBJ661 ;  CDS810010K , Lot Number 22BBT607 ;  CDS810010K , Lot Number 22FBG549 ;  CDS810010K , Lot Number 22FBG555 ;  CDS810010K , Lot Number 22HBF177 ;  CDS810010K , Lot Number 23DBF386 ;  CDS810010K , Lot Number 23IBF920 ;  CDS810010K , Lot Number 23KBF043 ;  CDS810010K , Lot Number 23KBW104 ;  CDS810010K , Lot Number 23KBW105 ;  CDS810010K , Lot Number 24ABB073 ;  CDS810023G, Lot Number 20DBK652;  CDS810023G, Lot Number 20DBA257;  CDS810023I, Lot Number 21GBP393;  CDS810023I, Lot Number 21FBE254;  CDS810023I, Lot Number 21BBS695;  CDS810023I, Lot Number 20WBE729;  CDS810023I, Lot Number 20IBG098;  CDS810023I, Lot Number 20GBU914;  CDS810023J, Lot Number 23JBI899;  CDS810023J, Lot Number 23EBQ471;  CDS810023J, Lot Number 23DBI051;  CDS810023J, Lot Number 23BBU273;  CDS810023J, Lot Number 23BBQ482;  CDS810023J, Lot Number 23ABB691;  CDS810023J, Lot Number 22LBF785;  CDS810023J, Lot Number 22IBG219;  CDS810023J, Lot Number 22HBR137;  CDS810023J, Lot Number 22GBK847;  CDS810023J, Lot Number 22EBS465;  CDS810023J, Lot Number 22BBF452;  CDS810023J, Lot Number 21LBI699;  CDS810023J, Lot Number 21JBQ842;  CDS810023K, Lot Number 23KBS455;  CDS810032L , Lot Number 19BBP945 ;  CDS810032L , Lot Number 19DBE971 ;  CDS810032L , Lot Number 19FBJ782 ;  CDS810032L , Lot Number 19FBZ139 ;  CDS810032L , Lot Number 19IBP875 ;  CDS810032L , Lot Number 19VBC448 ;  CDS810032L , Lot Number 19KBO504 ;  CDS810032L , Lot Number 20BBE593 ;  CDS810032L , Lot Number 20DBB545 ;  CDS810032L , Lot Number 20FBW326 ;  CDS810032L , Lot Number 20HBU689 ;  CDS810032L , Lot Number 21ABS929 ;  CDS810032L , Lot Number 21BBF822 ;  CDS810032M , Lot Number 21GBD880 ;  CDS810032M , Lot Number 21GBP404 ;  CDS810032M , Lot Number 21KBZ708 ;  CDS810032M , Lot Number 22EBB266 ;  CDS810032M , Lot Number 22EBC215 ;  CDS810032M , Lot Number 22GBF284 ;  CDS810032M , Lot Number 21EBC853 ;  CDS810032M , Lot Number 21FBG299 ;  CDS810032N , Lot Number 22HBI825 ;  CDS810032N , Lot Number 22JBC455 ;  CDS810032N , Lot Number 22KBM259 ;  CDS810032N , Lot Number 23ABJ740 ;  CDS810032N , Lot Number 23BBF830 ;  CDS810032N , Lot Number 23BBG484 ;  CDS810032O , Lot Number 23CBX494 ;  CDS810032O , Lot Number 23EBB627 ;  CDS810032O , Lot Number 23HBS135 ;  CDS810032O , Lot Number 23JBN138 ;  CDS810032O , Lot Number 23LBH820 ;  CDS810032O , Lot Number 24CBC478 ;  CDS981693I , Lot Number 21BBD922 ;  CDS981693I , Lot Number 21CBU573 ;  CDS981693I , Lot Number 21DBA609 ;  CDS981693I , Lot Number 19AKC609 ;  CDS981693I , Lot Number 19CKC217 ;  CDS981693I , Lot Number 19EKC233 ;  CDS981693I , Lot Number 19GKC208 ;  CDS981693I , Lot Number 19IKA370 ;  CDS981693I , Lot Number 19LKB506 ;  CDS981693I , Lot Number 20BKA414 ;  CDS981693I , Lot Number 20EKA431 ;  CDS981693I , Lot Number 20HKA662 ;  CDS981693I , Lot Number 20IKB479 ;  CDS981693J , Lot Number 21JBE505 ;  CDS981693J , Lot Number 21LBT097 ;  CDS981693J , Lot Number 22BBE157 ;  CDS981693J , Lot Number 22DBO666 ;  CDS981693J , Lot Number 22FBT390 ;  CDS981693J , Lot Number 22GBK042 ;  CDS981693J , Lot Number 22HBP398 ;  CDS981693J , Lot Number 22JBR298 ;  CDS981693J , Lot Number 22LBM190 ;  CDS981693J , Lot Number 23ABM722 ;  CDS981738A , Lot Number 21GBO965 ;  CDS981738A , Lot Number 21IBI529 ;  CDS981738A , Lot Number 21IBJ141 ;  CDS981738A , Lot Number 21IBV612 ;  CDS981738A , Lot Number 21LBN356 ;  CDS981738A , Lot Number 21LBO208 ;  CDS981738A , Lot Number 21LBQ519 ;  CDS981738A , Lot Number 19ABH611 ;  CDS981738A , Lot Number 22BBV851 ;  CDS981738A , Lot Number 22CBC489 ;  CDS981738A , Lot Number 19BBH122 ;  CDS981738A , Lot Number 19CBE522 ;  CDS981738A , Lot Number 22DBI014 ;  CDS981738A , Lot Number 22DBN355 ;  CDS981738A , Lot Number 19EBC008 ;  CDS981738A , Lot Number 22FBQ816 ;  CDS981738A , Lot Number 19FBE189 ;  CDS981738A , Lot Number 22HBI663 ;  CDS981738A , Lot Number 19GBL063 ;  CDS981738A , Lot Number 22JBO754 ;  CDS981738A , Lot Number 19IBL425 ;  CDS981738A , Lot Number 22KBS553 ;  CDS981738A , Lot Number 19JBH101 ;  CDS981738A , Lot Number 22LBN042 ;  CDS981738A , Lot Number 19JBP885 ;  CDS981738A , Lot Number 23ABE670 ;  CDS981738A , Lot Number 23BBJ857 ;  CDS981738A , Lot Number 19KBT839 ;  CDS981738A , Lot Number 23BBR114 ;  CDS981738A , Lot Number 23DBI029 ;  CDS981738A , Lot Number 23EBA987 ;  CDS981738A , Lot Number 23EBJ973 ;  CDS981738A , Lot Number 20BBC181 ;  CDS981738A , Lot Number 20BBD357 ;  CDS981738A , Lot Number 23EBT228 ;  CDS981738A , Lot Number 23FBD756 ;  CDS981738A , Lot Number 20BBW598 ;  CDS981738A , Lot Number 23FBO875 ;  CDS981738A , Lot Number 20CBP656 ;  CDS981738A , Lot Number 23GBI820 ;  CDS981738A , Lot Number 20DBH060 ;  CDS981738A , Lot Number 23HBH303 ;  CDS981738A , Lot Number 23JBG060 ;  CDS981738A , Lot Number 23JBQ234 ;  CDS981738A , Lot Number 23JBX012 ;  CDS981738A , Lot Number 23KBI691 ;  CDS981738A , Lot Number 20GBR847 ;  CDS981738A , Lot Number 23LBE694 ;  CDS981738A , Lot Number 20HBM595 ;  CDS981738A , Lot Number 23LBT877 ;  CDS981738A , Lot Number 20IBS360 ;  CDS981738A , Lot Number 20JBR679 ;  CDS981738A , Lot Number 21ABV556 ;  CDS981738A , Lot Number 21EBQ878 ;  CDS982059F , Lot Number 19EBD261 ;  CDS982059F , Lot Number 19FBU810 ;  CDS982059F , Lot Number 19HBC590 ;  CDS982059F , Lot Number 19HBP053 ;  CDS982059G , Lot Number 20CBJ228 ;  CDS982059G , Lot Number 20DBL294 ;  CDS982059G , Lot Number 20GBC189 ;  CDS982059G , Lot Number 20GBK661 ;  CDS982059G , Lot Number 20WBI665 ;  CDS982059G , Lot Number 21DBO027 ;  CDS982059G , Lot Number 21EBQ937 ;  CDS982059I , Lot Number 21HBI250 ;  CDS982059I , Lot Number 21IBA141 ;  CDS983001F , Lot Number 21JBJ722 ;  CDS983001F , Lot Number 19BBQ163 ;  CDS983001F , Lot Number 22GBZ046 ;  CDS983001F , Lot Number 22HBS626 ;  CDS983001F , Lot Number 20BBT822 ;  CDS983005F , Lot Number 21GBS636 ;  CDS983005F , Lot Number 21IBL034 ;  CDS983005F , Lot Number 21KBT458 ;  CDS983005F , Lot Number 22ABD363 ;  CDS983005F , Lot Number 22OBI234 ;  CDS983005F , Lot Number 22EBL338 ;  CDS983005F , Lot Number 22EBM253 ;  CDS983005F , Lot Number 19EBB052 ;  CDS983005F , Lot Number 22GBF484 ;  CDS983005F , Lot Number 19FBH227 ;  CDS983005F , Lot Number 22HBS280 ;  CDS983005F , Lot Number 19SBE960 ;  CDS983005F , Lot Number 22JBY299 ;  CDS983005F , Lot Number 22KBG359 ;  CDS983005F , Lot Number 19VBE092 ;  CDS983005F , Lot Number 23BBR601 ;  CDS983005F , Lot Number 23EBK408 ;  CDS983005F , Lot Number 20BBK586 ;  CDS983005F , Lot Number 23FBO409 ;  CDS983005F , Lot Number 20CBP244 ;  CDS983005F , Lot Number 20CBW510 ;  CDS983005F , Lot Number 23HBD978 ;  CDS983005F , Lot Number 23HBS884 ;  CDS983005F , Lot Number 20EBJ974 ;  CDS983005F , Lot Number 23IBO888 ;  CDS983005F , Lot Number 20GBR846 ;  CDS983005F , Lot Number 23KBP796 ;  CDS983005F , Lot Number 24ABF177 ;  CDS983005F , Lot Number 20IBQ469 ;  CDS983005F , Lot Number 20JBP761 ;  CDS983005F , Lot Number 20KBY143 ;  CDS983005F , Lot Number 20WBB814 ;  CDS983005F , Lot Number 21FBH213 ;  CDS983261D , Lot Number 19BKA785 ;  CDS983261D , Lot Number 19CKC018 ;  CDS983261F , Lot Number 21FBN765 ;  CDS983261F , Lot Number 21IBB971 ;  CDS983261F , Lot Number 20LBX511 ;  CDS983261F , Lot Number 21EBA050 ;  CDS983261F , Lot Number 19FKC272 ;  CDS983261F , Lot Number 19IKB888 ;  CDS983261F , Lot Number 19KKB008 ;  CDS983261F , Lot Number 20AKA955 ;  CDS983261F , Lot Number 20CKA362 ;  CDS983261F , Lot Number 20HKB821 ;  CDS983261G , Lot Number 21KBW951 ;  CDS983261G , Lot Number 22CBY035 ;  CDS983261G , Lot Number 22DBL429 ;  CDS983261G , Lot Number 22HMC405 ;  CDS983261G , Lot Number 22JMG522 ;  CDS983261G , Lot Number 22LMD012 ;  CDS983261G , Lot Number 22LMF075 ;  CDS983261G , Lot Number 23FMI202 ;  CDS983261G , Lot Number 23GMF257 ;  CDS983261G , Lot Number 23KME617 ;  CDS983261G , Lot Number 24BMG921 ;  CDS983753C , Lot Number 21FBQ262 ;  CDS983753C , Lot Number 19BBR117 ;  CDS983753C , Lot Number 19EBJ034 ;  CDS983753C , Lot Number 19FBO034 ;  CDS983753C , Lot Number 19TBE059 ;  CDS983753C , Lot Number 19IBY173 ;  CDS983753C , Lot Number 19LBW561 ;  CDS983753C , Lot Number 20ABN335 ;  CDS983753C , Lot Number 20DBT290 ;  CDS983753C , Lot Number 20EBI762 ;  CDS983753C , Lot Number 20FBC528 ;  CDS983753C , Lot Number 21ABJ230 ;  CDS983753C , Lot Number 21EBK769 ;  CDS983753C , Lot Number 21EBN821 ;  CDS983753C , Lot Number 21GMB108 ;  CDS983753D , Lot Number 21GMF207 ;  CDS983753D , Lot Number 21IMB034 ;  CDS983753D , Lot Number 22AMA507 ;  CDS983753D , Lot Number 22BMA325 ;  CDS983753D , Lot Number 23BME297 ;  CDS983753D , Lot Number 23CMB221 ;  CDS983753D , Lot Number 23CMB655 ;  CDS983753D , Lot Number 23GMB676 ;  CDS983753D , Lot Number 24AMJ173 ;  CDS983775I, Lot Number 23GBA705;  CDS983775I, Lot Number 23EBT206;  CDS983775I, Lot Number 23BBN853;  CDS983775I, Lot Number 23BBG437;  CDS983775I, Lot Number 23BBG444;  CDS983775I, Lot Number 23BBA852;  CDS983775I, Lot Number 23BBA859;  CDS983916F , Lot Number 19BBU018 ;  CDS983916F , Lot Number 19DBY270 ;  CDS983916G , Lot Number 21JBJ212 ;  CDS983916G , Lot Number 22CBV428 ;  CDS983916G , Lot Number 22GBP859 ;  CDS983916G , Lot Number 22HBP383 ;  CDS983916G , Lot Number 23EBP259 ;  CDS983916G , Lot Number 23GBG620 ;  CDS983916G , Lot Number 23HBT021 ;  CDS983916G , Lot Number 23IBS207 ;  CDS983916G , Lot Number 23JBW354 ; 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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-3051-2024&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-3051-2024&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-3051-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3051-2024 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",
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      "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-3051-2024&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-3051-2024&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-3051-2024/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",
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        "adjudged": false,
        "operative": true
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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          "item": {
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          "item": {
            "Field": "Reason",
            "Value": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
            "Status": "recorded"
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            "Field": "Initiated",
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 DYNJ0190619F , Lot Number 20DKA732 ;  DYNJ0190619F , Lot Number 20FKB285 ;  DYNJ0190619F , Lot Number 20JKA020 ;  DYNJ0190619G , Lot Number 20KMC490 ;  DYNJ0190619G , Lot Number 20LMC608 ;  DYNJ0190619G , Lot Number 21IMH127 ;  DYNJ0190619G , Lot Number 22AMB048 ;  DYNJ0190619G , Lot Number 23AMJ263 ;  DYNJ0198189D , Lot Number 19BKC561 ;  DYNJ0200004B , Lot Number 19EBN539 ;  DYNJ0200004B , Lot Number 19EBX494 ;  DYNJ0200004B , Lot Number 19HBO160 ;  DYNJ0200004B , Lot Number 19TBE985 ;  DYNJ0200004B , Lot Number 19IBY803 ;  DYNJ0200004B , Lot Number 19KBL633 ;  DYNJ0200004B , Lot Number 20BBW037 ;  DYNJ0200004B , Lot Number 20DBD156 ;  DYNJ0200004B , Lot Number 20FBS414 ;  DYNJ0200004B , Lot Number 20FBU454 ;  DYNJ0200004B , Lot Number 20IBI821 ;  DYNJ0200004B , Lot Number 20IBL143 ;  DYNJ0200004B , Lot Number 20JBN183 ;  DYNJ0200004B , Lot Number 20KBZ513 ;  DYNJ0200004B , Lot Number 20LBU313 ;  DYNJ0200004B , Lot Number 21DBJ821 ;  DYNJ0200004B , Lot Number 21HMG460 ;  DYNJ0200004B , Lot Number 21IMB734 ;  DYNJ0200004B , Lot Number 21JMA317 ;  DYNJ0200004B , Lot Number 21KMB559 ;  DYNJ0200004B , Lot Number 21KME916 ;  DYNJ0200004B , Lot Number 22DMI415 ;  DYNJ0200004B , Lot Number 22HME610 ;  DYNJ0200004B , Lot Number 22IMD552 ;  DYNJ0200004B , Lot Number 22JMH859 ;  DYNJ0200004B , Lot Number 22LMH732 ;  DYNJ0200004B , Lot Number 23BMA084 ;  DYNJ0200004B , Lot Number 23CMA756 ;  DYNJ0200004B , Lot Number 23DMB082 ;  DYNJ0200004B , Lot Number 23EMK172 ;  DYNJ0200004B , Lot Number 23GME617 ;  DYNJ0200004B , Lot Number 23GMI902 ;  DYNJ0200004B , Lot Number 23IME604 ;  DYNJ0200004B , Lot Number 23KMA198 ;  DYNJ0200004B , Lot Number 23KMJ007 ;  DYNJ0200004B , Lot Number 23LME804 ;  DYNJ0200004B , Lot Number 19AKB801 ;  DYNJ0200004B , Lot Number 19BKC639 ;  DYNJ0200004B , Lot Number 19DKA919 ;  DYNJ0259872L , Lot Number 19LMA530 ;  DYNJ0259872L , Lot Number 20BMA740 ;  DYNJ0259872L , Lot Number 20EMB246 ;  DYNJ0259872L , Lot Number 21FMF695 ;  DYNJ0259872L , Lot Number 21IMA827 ;  DYNJ0259872L , Lot Number 22AMC338 ;  DYNJ0259872L , Lot Number 22HME763 ;  DYNJ0259872L , Lot Number 22HME788 ;  DYNJ0259872L , Lot Number 19HKA176 ;  DYNJ02602D , Lot Number 19FBT873 ;  DYNJ02602D , Lot Number 19ADD166 ;  DYNJ02602D , Lot Number 19DDC154 ;  DYNJ02602D , Lot Number 19GDA990 ;  DYNJ02602D , Lot Number 19IDA302 ;  DYNJ02602D , Lot Number 19KDA819 ;  DYNJ02602D , Lot Number 20ADC403 ;  DYNJ02602D , Lot Number 20GDA386 ;  DYNJ02602D , Lot Number 20HDC553 ;  DYNJ02602D , Lot Number 20KDA012 ;  DYNJ02602D , Lot Number 21ADA699 ;  DYNJ02602F , Lot Number 21DDB755 ;  DYNJ02602F , Lot Number 21GDA028 ;  DYNJ02602G , Lot Number 21HDB505 ;  DYNJ02602G , Lot Number 21JDA497 ;  DYNJ02602G , Lot Number 21KDB695 ;  DYNJ02602G , Lot Number 22DDB775 ;  DYNJ02602G , Lot Number 22FDA206 ;  DYNJ02602G , Lot Number 22GDA402 ;  DYNJ02602G , Lot Number 22HDA755 ;  DYNJ02602G , Lot Number 22IDC106 ;  DYNJ02602G , Lot Number 22LDB934 ;  DYNJ02602G , Lot Number 24ADB473 ;  DYNJ02602G , Lot Number 24CDA263 ;  DYNJ0261302S , Lot Number 19AKB977 ;  DYNJ0261302T , Lot Number 19IMA826 ;  DYNJ0261302T , Lot Number 20AMA283 ;  DYNJ0261302T , Lot Number 20AMA994 ;  DYNJ0261302T , Lot Number 20FMA421 ;  DYNJ0261302T , Lot Number 20GMC134 ;  DYNJ0261302T , Lot Number 20GMD233 ;  DYNJ0261302T , Lot Number 20HMD645 ;  DYNJ0261302T , Lot Number 20IMD460 ;  DYNJ0261302T , Lot Number 20JMB141 ;  DYNJ0261302T , Lot Number 20KMA533 ;  DYNJ0261302T , Lot Number 20LMA828 ;  DYNJ0261302T , Lot Number 21EMC915 ;  DYNJ0261302T , Lot Number 21GMB540 ;  DYNJ0261302T , Lot Number 21HMA966 ;  DYNJ0261302T , Lot Number 21LMA726 ;  DYNJ0261302T , Lot Number 22BMD710 ;  DYNJ0261302T , Lot Number 22DMA393 ;  DYNJ0261302T , Lot Number 22FME154 ;  DYNJ0261302T , Lot Number 22HMA672 ;  DYNJ0261302T , Lot Number 23AMI832 ;  DYNJ0261302T , Lot Number 23CMC778 ;  DYNJ0261302T , Lot Number 23DME462 ;  DYNJ0261302T , Lot Number 23FMC970 ;  DYNJ0261302T , Lot Number 23GMA567 ;  DYNJ0261302T , Lot Number 23GMG148 ;  DYNJ0261302T , Lot Number 19CKD830 ;  DYNJ0261302T , Lot Number 19EKB885 ;  DYNJ0261302T , Lot Number 19EKD590 ;  DYNJ0261302T , Lot Number 19HKC932 ;  DYNJ0261302U , Lot Number 23KMH937 ;  DYNJ0261302U , Lot Number 24AME529 ;  DYNJ0264973AK, Lot Number 19AKC942 ;  DYNJ0264973AK, Lot Number 19BKD839 ;  DYNJ0264973AL, Lot Number 19HMA336 ;  DYNJ0264973AL, Lot Number 19JMA158 ;  DYNJ0264973AL, Lot Number 19LMC513 ;  DYNJ0264973AL, Lot Number 20BMB417 ;  DYNJ0264973AL, Lot Number 20GMC925 ;  DYNJ0264973AL, Lot Number 20HMD613 ;  DYNJ0264973AL, Lot Number 20LMD020 ;  DYNJ0264973AL, Lot Number 21BMA307 ;  DYNJ0264973AL, Lot Number 21CMC662 ;  DYNJ0264973AL, Lot Number 21FMA751 ;  DYNJ0264973AL, Lot Number 19DKA841 ;  DYNJ0264973AL, Lot Number 19EKB824 ;  DYNJ0264973AL, Lot Number 19FKB438 ;  DYNJ0264973AM, Lot Number 21GME384 ;  DYNJ0264973AM, Lot Number 21IMC453 ;  DYNJ0264973AM, Lot Number 21KMB235 ;  DYNJ0264973AM, Lot Number 21KMF571 ;  DYNJ0264973AM, Lot Number 22CMB137 ;  DYNJ0264973AN, Lot Number 22CMH757 ;  DYNJ0264973AN, Lot Number 22DMG902 ;  DYNJ0264973AN, Lot Number 22FMB109 ;  DYNJ0264973AN, Lot Number 22GME283 ;  DYNJ0264973AN, Lot Number 22HMH087 ;  DYNJ0264973AN, Lot Number 22IMF597 ;  DYNJ0264973AN, Lot Number 22JMC535 ;  DYNJ0264973AN, Lot Number 22KMA337 ;  DYNJ0264973AN, Lot Number 22LMA916 ;  DYNJ0264973AN, Lot Number 23AMC177 ;  DYNJ0264973AN, Lot Number 23BMH985 ;  DYNJ0264973AN, Lot Number 23CME770 ;  DYNJ0264973AN, Lot Number 23DME279 ;  DYNJ0264973AN, Lot Number 23EMA986 ;  DYNJ0264973AN, Lot Number 23FMC126 ;  DYNJ0264973AN, Lot Number 23FMI581 ;  DYNJ0264973AN, Lot Number 23HMD719 ;  DYNJ0264973AN, Lot Number 23IMI062 ;  DYNJ0264973AN, Lot Number 23KMI350 ;  DYNJ0264973AN, Lot Number 24AMI588 ;  DYNJ0275124L , Lot Number 19AKC126 ;  DYNJ0275124L , Lot Number 19BKD558 ;  DYNJ0275124L , Lot Number 19CKD029 ;  DYNJ0275124L , Lot Number 19DKB536 ;  DYNJ0275124L , Lot Number 19EKC498 ;  DYNJ0275124L , Lot Number 19GKB277 ;  DYNJ0275124L , Lot Number 19IKA328 ;  DYNJ0275124L , Lot Number 19IKC250 ;  DYNJ0275124L , Lot Number 19KKB069 ;  DYNJ0275124L , Lot Number 19LKB565 ;  DYNJ0290924N , Lot Number 21IBV454 ;  DYNJ0290924N , Lot Number 21KBJ472 ;  DYNJ0290924N , Lot Number 22NBE802 ;  DYNJ0290924N , Lot Number 19HBR213 ;  DYNJ0290924N , Lot Number 19IBZ882 ;  DYNJ0290924N , Lot Number 19KBJ762 ;  DYNJ0290924N , Lot Number 19LBV945 ;  DYNJ0290924N , Lot Number 20GBH377 ;  DYNJ0290924N , Lot Number 20HBS832 ;  DYNJ0290924N , Lot Number 21CBJ791 ;  DYNJ0290924N , Lot Number 23BMH691 ;  DYNJ0290924N , Lot Number 23DMI749 ;  DYNJ0317858M , Lot Number 22IMC900 ;  DYNJ0317858M , Lot Number 22IMD667 ;  DYNJ0317858M , Lot Number 22JMF894 ;  DYNJ0317858M , Lot Number 22KMH111 ;  DYNJ0317858M , Lot Number 23GMB519 ;  DYNJ0336700D , Lot Number 21EBP815 ;  DYNJ0336700D , Lot Number 20GKA064 ;  DYNJ0336700D , Lot Number 20HKB183 ;  DYNJ0336700D , Lot Number 20IKB242 ;  DYNJ0336700F , Lot Number 21IBV397 ;  DYNJ0336700F , Lot Number 21KBG921 ;  DYNJ0336700F , Lot Number 22GMG060 ;  DYNJ0336700F , Lot Number 22JMC537 ;  DYNJ0336700F , Lot Number 23AMF230 ;  DYNJ0336700F , Lot Number 23EMB598 ;  DYNJ0336700F , Lot Number 23FMA974 ;  DYNJ033670",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}