{
  "@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-0178-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline brand medical procedure convenience kits, labeled as:   1) EYE PACK, REF DYNJ19492L;  2) PHACO PACK, REF DYNJ22354L;  3) EYE PACK, REF DYNJ24573K;  4) EYE PACK, REF DYNJ30327A;  5) BASIC CATARACT PACK, REF DYNJ36868F;  6) BASIC RETINA PACK, REF DYNJ40811A;  7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A;  8) CATARACT PACK WRO-LF, REF DYNJ41861;  9) EYE PACK, REF DYNJ43911;  10) PHACO PACK, REF DYNJ44748I;  11) DR DRUMMOND EYE PACK, REF DYNJ45344G;  12) OPHTHALMIC PACK, REF DYNJ47275A;  13) CATARACT PACK, REF DYNJ49412B;  14) CATARACT PACK, REF DYNJ50948A;  15) CATARACT PACK, REF DYNJ50948A;  16) CATARACT DR MALONE PACK, REF DYNJ51590A;  17) CATARACT DR MALONE PACK, REF DYNJ51590A;  18) CUSTOM EYE TRAY, REF DYNJ51821B;  19) EYE SURGERY PACK, REF DYNJ53097C;  20) CATARACT KIT, REF DYNJ53944;  21) EYE PACK, REF DYNJ54847D;  22) PK, OPHTH-EYE, REF DYNJ55070B;  23) EYE PACK, REF DYNJ55320D;  24) PK, OPHTH-RETINA, REF DYNJ59253B;  25) RETINA PACK, REF DYNJ60515;  26) ASED KIT, REF DYNJ60745D;  27) CATARACT PACK, REF DYNJ61321B;  28) EYE PACK, REF DYNJ61862A;  29) CATARACT PACK DR FREDERICK, REF DYNJ63163;  30) CATARACT DR ESTOPINAL, REF DYNJ63164;  31) EYE CATARACT (BASIC EYE), REF DYNJ63272C;  32) EYE CATARACT (BASIC EYE), REF DYNJ63272C;  33) HMSL EYE PACK, REF DYNJ64537A;  34) EYE PACK, REF DYNJ65271C;  35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832;  36) BASIC CATARACT PACK, REF DYNJ69165D;  37) BASIC CATARACT PACK, REF DYNJ69165D;  38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082;  39) CATARACT PACK WITH NO TUB, REF DYNJ80232;  40) RETINA PACK, REF DYNJ80483;  41) RETINA PACK, REF DYNJ81640;  42) WESTFALL OCCUPLASTY, REF DYNJ81796A;  43) EYE PACK, REF DYNJ83799C;  44) OPHTHALMIC PACK, REF DYNJ85275;  45) CATARACT, REF DYNJ908059A;  46) EYE TRAY 1-LF, REF LLSCAEYE01A;  47) PHACO PACK, REF LYN011PHNHD;  48) PHACO PACK, REF LYN011PHNHD;  49) SPECIALTY BESSER PACK, REF LYN023BPSSD;  50) SPECIALTY BESSER PACK, REF LYN023BPSSD;  51) SPECIALTY BESSER PACK, REF LYN023BPSSD;  52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB;  53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB;  54) OPHTHALMIC PACK, REF LYN023OPSOB;  55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB;  56) BASIC CATARACT PACK, REF LYN030BCSDB;  57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA;  58) AIKEN CATARACT PACK II, REF LYN030CTAKG;  59) AIKEN CATARACT PACK II, REF LYN030CTAKG;  60) AIKEN CATARACT PACK II, REF LYN030CTAKG;  61) VA EYE II-LF, REF LYN030VAEYA;  62) VA EYE II-LF, REF LYN030VAEYA;  63) CATARACT PACK, REF LYN035CTSEC;  64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM;  65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM;  66) OPHTHALMIC PACK, REF LYN041OPFCC;  67) OPHTHALMIC PACK, REF LYN041OPFCC;  68) OPHTHALMIC PACK, REF LYN041OPFCC;  69) OPHTHALMIC PACK, REF LYN041OPFCC;  70) CATARACT PACK, REF LYN042CPFEG;  71) OPTHALMIC PACK-LF, REF PHS529724000B;  72) CATARACT PACK, REF VAL001CPMEB;  73) CATARACT PACK, REF VAL001CPMEB;  74) THE SURGERY CENTER CATARACT, REF VAL002CATSG;  75) THE SURGERY CENTER CATARACT, REF VAL002CATSG;  76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA;  77) CATARACT PACK, REF VAL009CAAHC;  78) RENAISSANCE CAT PACK, REF VAL009CAREA;  79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA;  80) CATARACT PACK, REF VAL009CTSGA;  81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC;  82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA;  83) RENAISSANCE VIT PACK, REF VAL009VIREA;  84) CATARACT PACK APERTURE, REF VAL011CTVAA;  85) OPHTHALMIC PACK, REF VAL022BSOMD;  86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD;  87) EYE PACK, REF VAL024EYTRB;  88) CATARACT PACK, REF VAL026CTNFC;  89) EYE PACK, REF VAL029EYGSB;  90) INTRAOCULAR PACK, REF VAL031IOGCB;  91) CATARACT, REF VAL035CPAEC;  92) CATARACT PACK 2, REF VAL036CABRD;  93) BRINTON VISION ICL PACK, REF VAL037ICBVG;  94) EYE PACK, REF VAL038BSCID;  95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB;  96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA;  97) BOOZMAN HOF PACK 2, REF VAL042EYBHC;  98) CATARACT PACK WILD",
  "description": "FDA recall Z-0178-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline brand medical procedure convenience kits, labeled as:   1) EYE PACK, REF DYNJ19492L;  2) PHACO PACK, REF DYNJ22354L;  3) EYE PACK, REF DYNJ24573K;  4) EYE PACK, REF DYNJ30327A;  5) BASIC CATARACT PACK, REF DYNJ36868F;  6) BASIC RETINA PACK, REF DYNJ40811A;  7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A;  8) CATARACT PACK WRO-LF, REF DYNJ41861;  9) EYE PACK, REF DYNJ43911;  10) PHACO PACK, REF DYNJ44748I;  11) DR DRUMMOND EYE PACK, REF DYNJ45344G;  12) OPHTHALMIC PACK, REF DYNJ47275A;  13) CATARACT PACK, REF DYNJ49412B;  14) CATARACT PACK, REF DYNJ50948A;  15) CATARACT PACK, REF DYNJ50948A;  16) CATARACT DR MALONE PACK, REF DYNJ51590A;  17) CATARACT DR MALONE PACK, REF DYNJ51590A;  18) CUSTOM EYE TRAY, REF DYNJ51821B;  19) EYE SURGERY PACK, REF DYNJ53097C;  20) CATARACT KIT, REF DYNJ53944;  21) EYE PACK, REF DYNJ54847D;  22) PK, OPHTH-EYE, REF DYNJ55070B;  23) EYE PACK, REF DYNJ55320D;  24) PK, OPHTH-RETINA, REF DYNJ59253B;  25) RETINA PACK, REF DYNJ60515;  26) ASED KIT, REF DYNJ60745D;  27) CATARACT PACK, REF DYNJ61321B;  28) EYE PACK, REF DYNJ61862A;  29) CATARACT PACK DR FREDERICK, REF DYNJ63163;  30) CATARACT DR ESTOPINAL, REF DYNJ63164;  31) EYE CATARACT (BASIC EYE), REF DYNJ63272C;  32) EYE CATARACT (BASIC EYE), REF DYNJ63272C;  33) HMSL EYE PACK, REF DYNJ64537A;  34) EYE PACK, REF DYNJ65271C;  35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832;  36) BASIC CATARACT PACK, REF DYNJ69165D;  37) BASIC CATARACT PACK, REF DYNJ69165D;  38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082;  39) CATARACT PACK WITH NO TUB, REF DYNJ80232;  40) RETINA PACK, REF DYNJ80483;  41) RETINA PACK, REF DYNJ81640;  42) WESTFALL OCCUPLASTY, REF DYNJ81796A;  43) EYE PACK, REF DYNJ83799C;  44) OPHTHALMIC PACK, REF DYNJ85275;  45) CATARACT, REF DYNJ908059A;  46) EYE TRAY 1-LF, REF LLSCAEYE01A;  47) PHACO PACK, REF LYN011PHNHD;  48) PHACO PACK, REF LYN011PHNHD;  49) SPECIALTY BESSER PACK, REF LYN023BPSSD;  50) SPECIALTY BESSER PACK, REF LYN023BPSSD;  51) SPECIALTY BESSER PACK, REF LYN023BPSSD;  52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB;  53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB;  54) OPHTHALMIC PACK, REF LYN023OPSOB;  55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB;  56) BASIC CATARACT PACK, REF LYN030BCSDB;  57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA;  58) AIKEN CATARACT PACK II, REF LYN030CTAKG;  59) AIKEN CATARACT PACK II, REF LYN030CTAKG;  60) AIKEN CATARACT PACK II, REF LYN030CTAKG;  61) VA EYE II-LF, REF LYN030VAEYA;  62) VA EYE II-LF, REF LYN030VAEYA;  63) CATARACT PACK, REF LYN035CTSEC;  64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM;  65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM;  66) OPHTHALMIC PACK, REF LYN041OPFCC;  67) OPHTHALMIC PACK, REF LYN041OPFCC;  68) OPHTHALMIC PACK, REF LYN041OPFCC;  69) OPHTHALMIC PACK, REF LYN041OPFCC;  70) CATARACT PACK, REF LYN042CPFEG;  71) OPTHALMIC PACK-LF, REF PHS529724000B;  72) CATARACT PACK, REF VAL001CPMEB;  73) CATARACT PACK, REF VAL001CPMEB;  74) THE SURGERY CENTER CATARACT, REF VAL002CATSG;  75) THE SURGERY CENTER CATARACT, REF VAL002CATSG;  76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA;  77) CATARACT PACK, REF VAL009CAAHC;  78) RENAISSANCE CAT PACK, REF VAL009CAREA;  79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA;  80) CATARACT PACK, REF VAL009CTSGA;  81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC;  82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA;  83) RENAISSANCE VIT PACK, REF VAL009VIREA;  84) CATARACT PACK APERTURE, REF VAL011CTVAA;  85) OPHTHALMIC PACK, REF VAL022BSOMD;  86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD;  87) EYE PACK, REF VAL024EYTRB;  88) CATARACT PACK, REF VAL026CTNFC;  89) EYE PACK, REF VAL029EYGSB;  90) INTRAOCULAR PACK, REF VAL031IOGCB;  91) CATARACT, REF VAL035CPAEC;  92) CATARACT PACK 2, REF VAL036CABRD;  93) BRINTON VISION ICL PACK, REF VAL037ICBVG;  94) EYE PACK, REF VAL038BSCID;  95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB;  96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA;  97) BOOZMAN HOF PACK 2, REF VAL042EYBHC;  98) CATARACT PACK WILD (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-0178-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline brand medical procedure convenience kits, labeled as:   1) EYE PACK, REF DYNJ19492L;  2) PHACO PACK, REF DYNJ22354L;  3) EYE PACK, REF DYNJ24573K;  4) EYE PACK, REF DYNJ30327A;  5) BASIC CATARACT PACK, REF DYNJ36868F;  6) BASIC RETINA PACK, REF DYNJ40811A;  7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A;  8) CATARACT PACK WRO-LF, REF DYNJ41861;  9) EYE PACK, REF DYNJ43911;  10) PHACO PACK, REF DYNJ44748I;  11) DR DRUMMOND EYE PACK, REF DYNJ45344G;  12) OPHTHALMIC PACK, REF DYNJ47275A;  13) CATARACT PACK, REF DYNJ49412B;  14) CATARACT PACK, REF DYNJ50948A;  15) CATARACT PACK, REF DYNJ50948A;  16) CATARACT DR MALONE PACK, REF DYNJ51590A;  17) CATARACT DR MALONE PACK, REF DYNJ51590A;  18) CUSTOM EYE TRAY, REF DYNJ51821B;  19) EYE SURGERY PACK, REF DYNJ53097C;  20) CATARACT KIT, REF DYNJ53944;  21) EYE PACK, REF DYNJ54847D;  22) PK, OPHTH-EYE, REF DYNJ55070B;  23) EYE PACK, REF DYNJ55320D;  24) PK, OPHTH-RETINA, REF DYNJ59253B;  25) RETINA PACK, REF DYNJ60515;  26) ASED KIT, REF DYNJ60745D;  27) CATARACT PACK, REF DYNJ61321B;  28) EYE PACK, REF DYNJ61862A;  29) CATARACT PACK DR FREDERICK, REF DYNJ63163;  30) CATARACT DR ESTOPINAL, REF DYNJ63164;  31) EYE CATARACT (BASIC EYE), REF DYNJ63272C;  32) EYE CATARACT (BASIC EYE), REF DYNJ63272C;  33) HMSL EYE PACK, REF DYNJ64537A;  34) EYE PACK, REF DYNJ65271C;  35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832;  36) BASIC CATARACT PACK, REF DYNJ69165D;  37) BASIC CATARACT PACK, REF DYNJ69165D;  38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082;  39) CATARACT PACK WITH NO TUB, REF DYNJ80232;  40) RETINA PACK, REF DYNJ80483;  41) RETINA PACK, REF DYNJ81640;  42) WESTFALL OCCUPLASTY, REF DYNJ81796A;  43) EYE PACK, REF DYNJ83799C;  44) OPHTHALMIC PACK, REF DYNJ85275;  45) CATARACT, REF DYNJ908059A;  46) EYE TRAY 1-LF, REF LLSCAEYE01A;  47) PHACO PACK, REF LYN011PHNHD;  48) PHACO PACK, REF LYN011PHNHD;  49) SPECIALTY BESSER PACK, REF LYN023BPSSD;  50) SPECIALTY BESSER PACK, REF LYN023BPSSD;  51) SPECIALTY BESSER PACK, REF LYN023BPSSD;  52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB;  53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB;  54) OPHTHALMIC PACK, REF LYN023OPSOB;  55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB;  56) BASIC CATARACT PACK, REF LYN030BCSDB;  57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA;  58) AIKEN CATARACT PACK II, REF LYN030CTAKG;  59) AIKEN CATARACT PACK II, REF LYN030CTAKG;  60) AIKEN CATARACT PACK II, REF LYN030CTAKG;  61) VA EYE II-LF, REF LYN030VAEYA;  62) VA EYE II-LF, REF LYN030VAEYA;  63) CATARACT PACK, REF LYN035CTSEC;  64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM;  65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM;  66) OPHTHALMIC PACK, REF LYN041OPFCC;  67) OPHTHALMIC PACK, REF LYN041OPFCC;  68) OPHTHALMIC PACK, REF LYN041OPFCC;  69) OPHTHALMIC PACK, REF LYN041OPFCC;  70) CATARACT PACK, REF LYN042CPFEG;  71) OPTHALMIC PACK-LF, REF PHS529724000B;  72) CATARACT PACK, REF VAL001CPMEB;  73) CATARACT PACK, REF VAL001CPMEB;  74) THE SURGERY CENTER CATARACT, REF VAL002CATSG;  75) THE SURGERY CENTER CATARACT, REF VAL002CATSG;  76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA;  77) CATARACT PACK, REF VAL009CAAHC;  78) RENAISSANCE CAT PACK, REF VAL009CAREA;  79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA;  80) CATARACT PACK, REF VAL009CTSGA;  81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC;  82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA;  83) RENAISSANCE VIT PACK, REF VAL009VIREA;  84) CATARACT PACK APERTURE, REF VAL011CTVAA;  85) OPHTHALMIC PACK, REF VAL022BSOMD;  86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD;  87) EYE PACK, REF VAL024EYTRB;  88) CATARACT PACK, REF VAL026CTNFC;  89) EYE PACK, REF VAL029EYGSB;  90) INTRAOCULAR PACK, REF VAL031IOGCB;  91) CATARACT, REF VAL035CPAEC;  92) CATARACT PACK 2, REF VAL036CABRD;  93) BRINTON VISION ICL PACK, REF VAL037ICBVG;  94) EYE PACK, REF VAL038BSCID;  95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB;  96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA;  97) BOOZMAN HOF PACK 2, REF VAL042EYBHC;  98) CATARACT PACK WILD",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0178-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0178-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline brand medical procedure convenience kits, labeled as:   1) EYE PACK, REF DYNJ19492L;  2) PHACO PACK, REF DYNJ22354L;  3) EYE PACK, REF DYNJ24573K;  4) EYE PACK, REF DYNJ30327A;  5) BASIC CATARACT PACK, REF DYNJ36868F;  6) BASIC RETINA PACK, REF DYNJ40811A;  7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A;  8) CATARACT PACK WRO-LF, REF DYNJ41861;  9) EYE PACK, REF DYNJ43911;  10) PHACO PACK, REF DYNJ44748I;  11) DR DRUMMOND EYE PACK, REF DYNJ45344G;  12) OPHTHALMIC PACK, REF DYNJ47275A;  13) CATARACT PACK, REF DYNJ49412B;  14) CATARACT PACK, REF DYNJ50948A;  15) CATARACT PACK, REF DYNJ50948A;  16) CATARACT DR MALONE PACK, REF DYNJ51590A;  17) CATARACT DR MALONE PACK, REF DYNJ51590A;  18) CUSTOM EYE TRAY, REF DYNJ51821B;  19) EYE SURGERY PACK, REF DYNJ53097C;  20) CATARACT KIT, REF DYNJ53944;  21) EYE PACK, REF DYNJ54847D;  22) PK, OPHTH-EYE, REF DYNJ55070B;  23) EYE PACK, REF DYNJ55320D;  24) PK, OPHTH-RETINA, REF DYNJ59253B;  25) RETINA PACK, REF DYNJ60515;  26) ASED KIT, REF DYNJ60745D;  27) CATARACT PACK, REF DYNJ61321B;  28) EYE PACK, REF DYNJ61862A;  29) CATARACT PACK DR FREDERICK, REF DYNJ63163;  30) CATARACT DR ESTOPINAL, REF DYNJ63164;  31) EYE CATARACT (BASIC EYE), REF DYNJ63272C;  32) EYE CATARACT (BASIC EYE), REF DYNJ63272C;  33) HMSL EYE PACK, REF DYNJ64537A;  34) EYE PACK, REF DYNJ65271C;  35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832;  36) BASIC CATARACT PACK, REF DYNJ69165D;  37) BASIC CATARACT PACK, REF DYNJ69165D;  38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082;  39) CATARACT PACK WITH NO TUB, REF DYNJ80232;  40) RETINA PACK, REF DYNJ80483;  41) RETINA PACK, REF DYNJ81640;  42) WESTFALL OCCUPLASTY, REF DYNJ81796A;  43) EYE PACK, REF DYNJ83799C;  44) OPHTHALMIC PACK, REF DYNJ85275;  45) CATARACT, REF DYNJ908059A;  46) EYE TRAY 1-LF, REF LLSCAEYE01A;  47) PHACO PACK, REF LYN011PHNHD;  48) PHACO PACK, REF LYN011PHNHD;  49) SPECIALTY BESSER PACK, REF LYN023BPSSD;  50) SPECIALTY BESSER PACK, REF LYN023BPSSD;  51) SPECIALTY BESSER PACK, REF LYN023BPSSD;  52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB;  53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB;  54) OPHTHALMIC PACK, REF LYN023OPSOB;  55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB;  56) BASIC CATARACT PACK, REF LYN030BCSDB;  57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA;  58) AIKEN CATARACT PACK II, REF LYN030CTAKG;  59) AIKEN CATARACT PACK II, REF LYN030CTAKG;  60) AIKEN CATARACT PACK II, REF LYN030CTAKG;  61) VA EYE II-LF, REF LYN030VAEYA;  62) VA EYE II-LF, REF LYN030VAEYA;  63) CATARACT PACK, REF LYN035CTSEC;  64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM;  65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM;  66) OPHTHALMIC PACK, REF LYN041OPFCC;  67) OPHTHALMIC PACK, REF LYN041OPFCC;  68) OPHTHALMIC PACK, REF LYN041OPFCC;  69) OPHTHALMIC PACK, REF LYN041OPFCC;  70) CATARACT PACK, REF LYN042CPFEG;  71) OPTHALMIC PACK-LF, REF PHS529724000B;  72) CATARACT PACK, REF VAL001CPMEB;  73) CATARACT PACK, REF VAL001CPMEB;  74) THE SURGERY CENTER CATARACT, REF VAL002CATSG;  75) THE SURGERY CENTER CATARACT, REF VAL002CATSG;  76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA;  77) CATARACT PACK, REF VAL009CAAHC;  78) RENAISSANCE CAT PACK, REF VAL009CAREA;  79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA;  80) CATARACT PACK, REF VAL009CTSGA;  81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC;  82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA;  83) RENAISSANCE VIT PACK, REF VAL009VIREA;  84) CATARACT PACK APERTURE, REF VAL011CTVAA;  85) OPHTHALMIC PACK, REF VAL022BSOMD;  86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD;  87) EYE PACK, REF VAL024EYTRB;  88) CATARACT PACK, REF VAL026CTNFC;  89) EYE PACK, REF VAL029EYGSB;  90) INTRAOCULAR PACK, REF VAL031IOGCB;  91) CATARACT, REF VAL035CPAEC;  92) CATARACT PACK 2, REF VAL036CABRD;  93) BRINTON VISION ICL PACK, REF VAL037ICBVG;  94) EYE PACK, REF VAL038BSCID;  95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB;  96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA;  97) BOOZMAN HOF PACK 2, REF VAL042EYBHC;  98) CATARACT PACK WILD",
      "text": "The FDA logged enforcement record Z-0178-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline brand medical procedure convenience kits, labeled as:   1) EYE PACK, REF DYNJ19492L;  2) PHACO PACK, REF DYNJ22354L;  3) EYE PACK, REF DYNJ24573K;  4) EYE PACK, REF DYNJ30327A;  5) BASIC CATARACT PACK, REF DYNJ36868F;  6) BASIC RETINA PACK, REF DYNJ40811A;  7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A;  8) CATARACT PACK WRO-LF, REF DYNJ41861;  9) EYE PACK, REF DYNJ43911;  10) PHACO PACK, REF DYNJ44748I;  11) DR DRUMMOND EYE PACK, REF DYNJ45344G;  12) OPHTHALMIC PACK, REF DYNJ47275A;  13) CATARACT PACK, REF DYNJ49412B;  14) CATARACT PACK, REF DYNJ50948A;  15) CATARACT PACK, REF DYNJ50948A;  16) CATARACT DR MALONE PACK, REF DYNJ51590A;  17) CATARACT DR MALONE PACK, REF DYNJ51590A;  18) CUSTOM EYE TRAY, REF DYNJ51821B;  19) EYE SURGERY PACK, REF DYNJ53097C;  20) CATARACT KIT, REF DYNJ53944;  21) EYE PACK, REF DYNJ54847D;  22) PK, OPHTH-EYE, REF DYNJ55070B;  23) EYE PACK, REF DYNJ55320D;  24) PK, OPHTH-RETINA, REF DYNJ59253B;  25) RETINA PACK, REF DYNJ60515;  26) ASED KIT, REF DYNJ60745D;  27) CATARACT PACK, REF DYNJ61321B;  28) EYE PACK, REF DYNJ61862A;  29) CATARACT PACK DR FREDERICK, REF DYNJ63163;  30) CATARACT DR ESTOPINAL, REF DYNJ63164;  31) EYE CATARACT (BASIC EYE), REF DYNJ63272C;  32) EYE CATARACT (BASIC EYE), REF DYNJ63272C;  33) HMSL EYE PACK, REF DYNJ64537A;  34) EYE PACK, REF DYNJ65271C;  35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832;  36) BASIC CATARACT PACK, REF DYNJ69165D;  37) BASIC CATARACT PACK, REF DYNJ69165D;  38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082;  39) CATARACT PACK WITH NO TUB, REF DYNJ80232;  40) RETINA PACK, REF DYNJ80483;  41) RETINA PACK, REF DYNJ81640;  42) WESTFALL OCCUPLASTY, REF DYNJ81796A;  43) EYE PACK, REF DYNJ83799C;  44) OPHTHALMIC PACK, REF DYNJ85275;  45) CATARACT, REF DYNJ908059A;  46) EYE TRAY 1-LF, REF LLSCAEYE01A;  47) PHACO PACK, REF LYN011PHNHD;  48) PHACO PACK, REF LYN011PHNHD;  49) SPECIALTY BESSER PACK, REF LYN023BPSSD;  50) SPECIALTY BESSER PACK, REF LYN023BPSSD;  51) SPECIALTY BESSER PACK, REF LYN023BPSSD;  52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB;  53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB;  54) OPHTHALMIC PACK, REF LYN023OPSOB;  55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB;  56) BASIC CATARACT PACK, REF LYN030BCSDB;  57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA;  58) AIKEN CATARACT PACK II, REF LYN030CTAKG;  59) AIKEN CATARACT PACK II, REF LYN030CTAKG;  60) AIKEN CATARACT PACK II, REF LYN030CTAKG;  61) VA EYE II-LF, REF LYN030VAEYA;  62) VA EYE II-LF, REF LYN030VAEYA;  63) CATARACT PACK, REF LYN035CTSEC;  64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM;  65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM;  66) OPHTHALMIC PACK, REF LYN041OPFCC;  67) OPHTHALMIC PACK, REF LYN041OPFCC;  68) OPHTHALMIC PACK, REF LYN041OPFCC;  69) OPHTHALMIC PACK, REF LYN041OPFCC;  70) CATARACT PACK, REF LYN042CPFEG;  71) OPTHALMIC PACK-LF, REF PHS529724000B;  72) CATARACT PACK, REF VAL001CPMEB;  73) CATARACT PACK, REF VAL001CPMEB;  74) THE SURGERY CENTER CATARACT, REF VAL002CATSG;  75) THE SURGERY CENTER CATARACT, REF VAL002CATSG;  76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA;  77) CATARACT PACK, REF VAL009CAAHC;  78) RENAISSANCE CAT PACK, REF VAL009CAREA;  79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA;  80) CATARACT PACK, REF VAL009CTSGA;  81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC;  82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA;  83) RENAISSANCE VIT PACK, REF VAL009VIREA;  84) CATARACT PACK APERTURE, REF VAL011CTVAA;  85) OPHTHALMIC PACK, REF VAL022BSOMD;  86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD;  87) EYE PACK, REF VAL024EYTRB;  88) CATARACT PACK, REF VAL026CTNFC;  89) EYE PACK, REF VAL029EYGSB;  90) INTRAOCULAR PACK, REF VAL031IOGCB;  91) CATARACT, REF VAL035CPAEC;  92) CATARACT PACK 2, REF VAL036CABRD;  93) BRINTON VISION ICL PACK, REF VAL037ICBVG;  94) EYE PACK, REF VAL038BSCID;  95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB;  96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA;  97) BOOZMAN HOF PACK 2, REF VAL042EYBHC;  98) CATARACT PACK WILD — reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-09-04. Affected lots/codes: 1) REF DYNJ19492L, UDI/DI 40195327368587 (each), 10195327368586 (case), Lot Numbers:  24ABE741;  2) REF DYNJ22354L, UDI/DI 40195327239924 (each), 10195327239923 (case), Lot Numbers:  23LBN139;  3) REF DYNJ24573K, UDI/DI 40195327144303 (each), 10195327144302 (case), Lot Numbers:  23KBB931;  4) REF DYNJ30327A, UDI/DI 40193489997089 (each), 10193489997088 (case), Lot Numbers:  24ABB714;  5) REF DYNJ36868F, UDI/DI 40888277897060 (each), 10888277897069 (case), Lot Numbers:  23KBD160;  6) REF DYNJ40811A, UDI/DI 40888277014634 (each), 10888277014633 (case), Lot Numbers:  23KBE584;  7) REF DYNJ41769A, UDI/DI 40888277267825 (each), 10888277267824 (case), Lot Numbers:  23KBB744;  8) REF DYNJ41861, UDI/DI 40888277020741 (each), 10888277020740 (case), Lot Numbers:  23KBB746;  9) REF DYNJ43911, UDI/DI 40888277073617 (each), 10888277073616 (case), Lot Numbers:  23LBQ741;  10) REF DYNJ44748I, UDI/DI 40193489273459 (each), 10193489273458 (case), Lot Numbers:  23LBP074;  11) REF DYNJ45344G, UDI/DI 40195327402922 (each), 10195327402921 (case), Lot Numbers:  23LBU068;  12) REF DYNJ47275A, UDI/DI 40888277571946 (each), 10888277571945 (case), Lot Numbers:  24ABE470;  13) REF DYNJ49412B, UDI/DI 40889942935278 (each), 10889942935277 (case), Lot Numbers:  24ABD256;  14) REF DYNJ50948A, UDI/DI 40195327117550 (each), 10195327117559 (case), Lot Numbers:  24ABC786;  15) REF DYNJ50948A, UDI/DI 40195327117550 (each), 10195327117559 (case), Lot Numbers:  23KBA350;  16) REF DYNJ51590A, UDI/DI 40193489721387 (each), 10193489721386 (case), Lot Numbers:  23LBN087;  17) REF DYNJ51590A, UDI/DI 40193489721387 (each), 10193489721386 (case), Lot Numbers:  23KBE531;  18) REF DYNJ51821B, UDI/DI 40193489963374 (each), 10193489963373 (case), Lot Numbers:  23KBE568;  19) REF DYNJ53097C, UDI/DI 40889942721376 (each), 10889942721375 (case), Lot Numbers:  24ABC180;  20) REF DYNJ53944, UDI/DI 40889942450689 (each), 10889942450688 (case), Lot Numbers:  23LBR325;  21) REF DYNJ54847D, UDI/DI 40193489266659 (each), 10193489266658 (case), Lot Numbers:  23LBI510;  22) REF DYNJ55070B, UDI/DI 40193489800686 (each), 10193489800685 (case), Lot Numbers:  23LBU001;  23) REF DYNJ55320D, UDI/DI 40195327429219 (each), 10195327429218 (case), Lot Numbers:  24ABD339;  24) REF DYNJ59253B, UDI/DI 40193489269322 (each), 10193489269321 (case), Lot Numbers:  24ABB328;  25) REF DYNJ60515, UDI/DI 40193489510240 (each), 10193489510249 (case), Lot Numbers:  24ABE890;  26) REF DYNJ60745D, UDI/DI 40193489949309 (each), 10193489949308 (case), Lot Numbers:  24ABA754;  27) REF DYNJ61321B, UDI/DI 40193489794411 (each), 10193489794410 (case), Lot Numbers:  23KBF225;  28) REF DYNJ61862A, UDI/DI 40195327216826 (each), 10195327216825 (case), Lot Numbers:  23KBC772;  29) REF DYNJ63163, UDI/DI 40193489721585 (each), 10193489721584 (case), Lot Numbers:  23LBL330;  30) REF DYNJ63164, UDI/DI 40193489721592 (each), 10193489721591 (case), Lot Numbers:  23LBN120;  31) REF DYNJ63272C, UDI/DI 40195327532254 (each), 10195327532253 (case), Lot Numbers:  24ABC862;  32) REF DYNJ63272C, UDI/DI 40195327532254 (each), 10195327532253 (case), Lot Numbers:  23KBI662;  33) REF DYNJ64537A, UDI/DI 40195327518494 (each), 10195327518493 (case), Lot Numbers:  24ABC540;  34) REF DYNJ65271C, UDI/DI 40193489957946 (each), 10193489957945 (case), Lot Numbers:  23KBC696;  35) REF DYNJ66832, UDI/DI 40193489389051 (each), 10193489389050 (case), Lot Numbers:  23KBE083;  36) REF DYNJ69165D, UDI/DI 40195327224340 (each), 10195327224349 (case), Lot Numbers:  23LBP941;  37) REF DYNJ69165D, UDI/DI 40195327224340 (each), 10195327224349 (case), Lot Numbers:  23KBE571;  38) REF DYNJ80082, UDI/DI 40195327012008 (each), 10195327012007 (case), Lot Numbers:  24ABD342;  39) REF DYNJ80232, UDI/DI 40195327017065 (each), 10195327017064 (case), Lot Numbers:  23LBN193;  40) REF DYNJ80483, UDI/DI 40195327045341 (each), 10195327045340 (case), Lot Numbers:  24ABC583;  41) REF DYNJ81640, UDI/DI 40195327129478 (each), 10195327129477 (case), Lot Numbers:  23LBK169;  42) REF DYNJ81796A, UDI/DI 40195327570386 (each), 10195327570385 (case), Lot Numbers:  23LBN670;  43) REF DYNJ83799C, UDI/DI 40195327443932 (each), 10195327443931 (case), Lot Numbers:  23LBP953;  44) REF DYNJ85275, UDI/DI 40195327484690 (each), 10195327484699 (case), Lot Numbers:  24ABA128;  45) REF DYNJ908059A, UDI/DI 40195327125432 (each), 10195327125431 (case), Lot Numbers:  23LBT833;  46) REF LLSCAEYE01A, UDI/DI 40884389376981 (each), 10884389376980 (case), Lot Numbers:  23KBB457;  47) REF LYN011PHNHD, UDI/DI 40193489234405 (each), 10193489234404 (case), Lot Numbers:  24ABD326;  48) REF LYN011PHNHD, UDI/DI 40193489234405 (each), 10193489234404 (case), Lot Numbers:  24ABA918;  49) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers:  24ABA470;  50) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers:  23LBN465;  51) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers:  23KBF760;  52) REF LYN023BSBLB, UDI/DI 40889942336242 (each), 10889942336241 (case), Lot Numbers:  24ABC586;  53) REF LYN023BSBLB, UDI/DI 40889942336242 (each), 10889942336241 (case), Lot Numbers:  24ABD327;  54) REF LYN023OPSOB, UDI/DI 40889942375791 (each), 10889942375790 (case), Lot Numbers:  24ABD328;  55) REF LYN024CACSB, UDI/DI 40195327095735 (each), 10195327095734 (case), Lot Numbers:  23LBN673;  56) REF LYN030BCSDB, UDI/DI 40193489457965 (each), 10193489457964 (case), Lot Numbers:  24ABH583;  57) REF LYN030CPSSA, UDI/DI 40195327128549 (each), 10195327128548 (case), Lot Numbers:  23KBD385;  58) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers:  24ABA502;  59) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers:  23LBP443;  60) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers:  23LBQ089;  61) REF LYN030VAEYA, UDI/DI 40195327242917 (each), 10195327242916 (case), Lot Numbers:  24ABA893;  62) REF LYN030VAEYA, UDI/DI 40195327242917 (each), 10195327242916 (case), Lot Numbers:  24ABD329;  63) REF LYN035CTSEC, UDI/DI 40889942532026 (each), 10889942532025 (case), Lot Numbers:  23KBC621;  64) REF LYN037DBEYM, UDI/DI 40193489473910 (each), 10193489473919 (case), Lot Numbers:  23LBQ090;  65) REF LYN037DBEYM, UDI/DI 40193489473910 (each), 10193489473919 (case), Lot Numbers:  23KBD746;  66) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers:  24ABD867;  67) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers:  23LBN722;  68) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers:  23LBA842;  69) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers:  23KBD251;  70) REF LYN042CPFEG, UDI/DI 40193489219372 (each), 10193489219371 (case), Lot Numbers:  23KBC622;  71) REF PHS529724000B, UDI/DI 40195327166022 (each), 10195327166021 (case), Lot Numbers:  23KBE642;  72) REF VAL001CPMEB, UDI/DI 40195327205455 (each), 10195327205454 (case), Lot Numbers:  24ABE054;  73) REF VAL001CPMEB, UDI/DI 40195327205455 (each), 10195327205454 (case), Lot Numbers:  23LBH892;  74) REF VAL002CATSG, UDI/DI 40195327250417 (each), 10195327250416 (case), Lot Numbers:  24ABN974;  75) REF VAL002CATSG, UDI/DI 40195327250417 (each), 10195327250416 (case), Lot Numbers:  23KBC653;  76) REF VAL003REPEA, UDI/DI 40889942968382 (each), 10889942968381 (case), Lot Numbers:  24ABF774;  77) REF VAL009CAAHC, UDI/DI 40195327260300 (each), 10195327260309 (case), Lot Numbers:  23KBB402;  78) REF VAL009CAREA, UDI/DI 40193489462242 (each), 10193489462241 (case), Lot Numbers:  23KBC624;  79) REF VAL009CATEA, UDI/DI 40889942872399 (each), 10889942872398 (case), Lot Numbers:  24ABA924;  80) REF VAL009CTSGA, UDI/DI 40193489577540 (each), 10193489577549 (case), Lot Numbers:  24ABA478;  81) REF VAL009EYDLC, UDI/DI 40195327302291 (each), 10195327302290 (case), Lot Numbers:  24ABE052;  82) REF VAL009RETGA, UDI/DI 40193489676991 (each), 10193489676990 (case), Lot Numbers:  23LBQ654;  83) REF VAL009VIREA, UDI/DI 40193489462259 (each), 10193489462258 (case), Lot Numbers:  24ABA925;  84) REF VAL011CTVAA, UDI/DI 40889942005568 (each), 10889942005567 (case), Lot Numbers:  23KBC625;  85) REF VAL022BSOMD, UDI/DI 40889942760214 (each), 10889942760213 (case), Lot Numbers:  23LBQ097;  86) REF VAL024CAIOD, UDI/DI 40193489491525 (each), 10193489491524 (case), Lot Numbers:  23KBB700;  87) REF VAL024EYTRB, UDI/DI 40193489426008 (each), 10193489426007 (case), Lot Numbers:  23LBN467;  88) REF VAL026CTNFC, UDI/DI 40193489458412 (each), 10193489458411 (case), Lot Numbers:  23LBA843;  89) REF VAL029EYGSB, UDI/DI 40193489550727 (each), 10193489550726 (case), Lot Numbers:  23KBT152;  90) REF VAL031IOGCB, UDI/DI 40889942307198 (each), 10889942307197 (case), Lot Numbers:  24ABA898;  91) REF VAL035CPAEC, UDI/DI 40889942537373 (each), 10889942537372 (case), Lot Numbers:  23KBE643;  92) REF VAL036CABRD, UDI/DI 40195327196159 (each), 10195327196158 (case), Lot Numbers:  23KBC657;  93) REF VAL037ICBVG, UDI/DI 40193489868136 (each), 10193489868135 (case), Lot Numbers:  23KBC628;  94) REF VAL038BSCID, UDI/DI 40888277761767 (each), 10888277761766 (case), Lot Numbers:  23KBC629;  95) REF VAL038CTECB, UDI/DI 40889942867883 (each), 10889942867882 (case), Lot Numbers:  23LBP453;  96) REF VAL041EPSWA, UDI/DI 40193489394550 (each), 10193489394559 (case), Lot Numbers:  24ABA469;  97) REF VAL042EYBHC, UDI/DI 40195327033249 (each), 10195327033248 (case), Lot Numbers:  23KBD595;  98) REF VAL046CAWCA, UDI/DI 40193489846721 (each), 10193489846720 (case), Lot Numbers:  23LBM013;  99) REF VAL047VIVOA, UDI/DI 40193489375122 (each), 10193489375121 (case), Lot Numbers:  23LBM392;  100) REF VAL048TSCCA, UDI/DI 40195327250455 (each), 10195327250454 (case), Lot Numbers:  23LBQ099;  101) REF VAL048TSCCA, UDI/DI 40195327250455 (each), 10195327250454 (case), Lot Numbers:  23KBC660;  102) REF VAL050CTFEI, UDI/DI 40193489368063 (each), 10193489368062 (case), Lot Numbers:  24ABA899;  103) REF VAL050EEPKB, UDI/DI 40195327267149 (each), 10195327267148 (case), Lot Numbers:  24ABA472;  104) REF VAL050ITKEA, UDI/DI 40195327134090 (each), 10195327134099 (case), Lot Numbers:  23KBK068;  105) REF VAL050REBOB, UDI/DI 40193489833653 (each), 10193489833652 (case), Lot Numbers:  24ABA477;  106) REF VAL050VIAHD, UDI/DI 40195327195565 (each), 10195327195564 (case), Lot Numbers:  23JBU308;  107) REF VAL054CAMAA, UDI/DI 40193489228114 (each), 10193489228113 (case), Lot Numbers:  23LBQ100;  108) REF VAL059DKSWB, UDI/DI 40193489667951 (each), 10193489667950 (case), Lot Numbers:  23KBE384;  109) REF VAL075EYLSA, UDI/DI 40889942804345 (each), 10889942804344 (case), Lot Numbers:  23LBP466;  110) REF VAL089EYRUA, UDI/DI 40193489438162 (each), 10193489438161 (case), Lot Numbers:  23LBP468. 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-0178-2025&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-0178-2025&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-0178-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0178-2025 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-0178-2025&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-0178-2025&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-0178-2025/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": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0178-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0178-2025",
            "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": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-09-04",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) REF DYNJ19492L, UDI/DI 40195327368587 (each), 10195327368586 (case), Lot Numbers:  24ABE741;  2) REF DYNJ22354L, UDI/DI 40195327239924 (each), 10195327239923 (case), Lot Numbers:  23LBN139;  3) REF DYNJ24573K, UDI/DI 40195327144303 (each), 10195327144302 (case), Lot Numbers:  23KBB931;  4) REF DYNJ30327A, UDI/DI 40193489997089 (each), 10193489997088 (case), Lot Numbers:  24ABB714;  5) REF DYNJ36868F, UDI/DI 40888277897060 (each), 10888277897069 (case), Lot Numbers:  23KBD160;  6) REF DYNJ40811A, UDI/DI 40888277014634 (each), 10888277014633 (case), Lot Numbers:  23KBE584;  7) REF DYNJ41769A, UDI/DI 40888277267825 (each), 10888277267824 (case), Lot Numbers:  23KBB744;  8) REF DYNJ41861, UDI/DI 40888277020741 (each), 10888277020740 (case), Lot Numbers:  23KBB746;  9) REF DYNJ43911, UDI/DI 40888277073617 (each), 10888277073616 (case), Lot Numbers:  23LBQ741;  10) REF DYNJ44748I, UDI/DI 40193489273459 (each), 10193489273458 (case), Lot Numbers:  23LBP074;  11) REF DYNJ45344G, UDI/DI 40195327402922 (each), 10195327402921 (case), Lot Numbers:  23LBU068;  12) REF DYNJ47275A, UDI/DI 40888277571946 (each), 10888277571945 (case), Lot Numbers:  24ABE470;  13) REF DYNJ49412B, UDI/DI 40889942935278 (each), 10889942935277 (case), Lot Numbers:  24ABD256;  14) REF DYNJ50948A, UDI/DI 40195327117550 (each), 10195327117559 (case), Lot Numbers:  24ABC786;  15) REF DYNJ50948A, UDI/DI 40195327117550 (each), 10195327117559 (case), Lot Numbers:  23KBA350;  16) REF DYNJ51590A, UDI/DI 40193489721387 (each), 10193489721386 (case), Lot Numbers:  23LBN087;  17) REF DYNJ51590A, UDI/DI 40193489721387 (each), 10193489721386 (case), Lot Numbers:  23KBE531;  18) REF DYNJ51821B, UDI/DI 40193489963374 (each), 10193489963373 (case), Lot Numbers:  23KBE568;  19) REF DYNJ53097C, UDI/DI 40889942721376 (each), 10889942721375 (case), Lot Numbers:  24ABC180;  20) REF DYNJ53944, UDI/DI 40889942450689 (each), 10889942450688 (case), Lot Numbers:  23LBR325;  21) REF DYNJ54847D, UDI/DI 40193489266659 (each), 10193489266658 (case), Lot Numbers:  23LBI510;  22) REF DYNJ55070B, UDI/DI 40193489800686 (each), 10193489800685 (case), Lot Numbers:  23LBU001;  23) REF DYNJ55320D, UDI/DI 40195327429219 (each), 10195327429218 (case), Lot Numbers:  24ABD339;  24) REF DYNJ59253B, UDI/DI 40193489269322 (each), 10193489269321 (case), Lot Numbers:  24ABB328;  25) REF DYNJ60515, UDI/DI 40193489510240 (each), 10193489510249 (case), Lot Numbers:  24ABE890;  26) REF DYNJ60745D, UDI/DI 40193489949309 (each), 10193489949308 (case), Lot Numbers:  24ABA754;  27) REF DYNJ61321B, UDI/DI 40193489794411 (each), 10193489794410 (case), Lot Numbers:  23KBF225;  28) REF DYNJ61862A, UDI/DI 40195327216826 (each), 10195327216825 (case), Lot Numbers:  23KBC772;  29) REF DYNJ63163, UDI/DI 40193489721585 (each), 10193489721584 (case), Lot Numbers:  23LBL330;  30) REF DYNJ63164, UDI/DI 40193489721592 (each), 10193489721591 (case), Lot Numbers:  23LBN120;  31) REF DYNJ63272C, UDI/DI 40195327532254 (each), 10195327532253 (case), Lot Numbers:  24ABC862;  32) REF DYNJ63272C, UDI/DI 40195327532254 (each), 10195327532253 (case), Lot Numbers:  23KBI662;  33) REF DYNJ64537A, UDI/DI 40195327518494 (each), 10195327518493 (case), Lot Numbers:  24ABC540;  34) REF DYNJ65271C, UDI/DI 40193489957946 (each), 10193489957945 (case), Lot Numbers:  23KBC696;  35) REF DYNJ66832, UDI/DI 40193489389051 (each), 10193489389050 (case), Lot Numbers:  23KBE083;  36) REF DYNJ69165D, UDI/DI 40195327224340 (each), 10195327224349 (case), Lot Numbers:  23LBP941;  37) REF DYNJ69165D, UDI/DI 40195327224340 (each), 10195327224349 (case), Lot Numbers:  23KBE571;  38) REF DYNJ80082, UDI/DI 40195327012008 (each), 10195327012007 (case), Lot Numbers:  24ABD342;  39) REF DYNJ80232, UDI/DI 40195327017065 (each), 10195327017064 (case), Lot Numbers:  23LBN193;  40) REF DYNJ80483, UDI/DI 40195327045341 (each), 10195327045340 (case), Lot Numbers:  24ABC583;  41) REF DYNJ81640, UDI/DI 40195327129478 (each), 10195327129477 (case), Lot Numbers:  23LBK169;  42) REF DYNJ81796A, UDI/DI 40195327570386 (each), 10195327570385 (case), Lot Numbers:  23LBN670;  43) REF DYNJ83799C, UDI/DI 40195327443932 (each), 10195327443931 (case), Lot Numbers:  23LBP953;  44) REF DYNJ85275, UDI/DI 40195327484690 (each), 10195327484699 (case), Lot Numbers:  24ABA128;  45) REF DYNJ908059A, UDI/DI 40195327125432 (each), 10195327125431 (case), Lot Numbers:  23LBT833;  46) REF LLSCAEYE01A, UDI/DI 40884389376981 (each), 10884389376980 (case), Lot Numbers:  23KBB457;  47) REF LYN011PHNHD, UDI/DI 40193489234405 (each), 10193489234404 (case), Lot Numbers:  24ABD326;  48) REF LYN011PHNHD, UDI/DI 40193489234405 (each), 10193489234404 (case), Lot Numbers:  24ABA918;  49) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers:  24ABA470;  50) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers:  23LBN465;  51) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers:  23KBF760;  52) REF LYN023BSBLB, UDI/DI 40889942336242 (each), 10889942336241 (case), Lot Numbers:  24ABC586;  53) REF LYN023BSBLB, UDI/DI 40889942336242 (each), 10889942336241 (case), Lot Numbers:  24ABD327;  54) REF LYN023OPSOB, UDI/DI 40889942375791 (each), 10889942375790 (case), Lot Numbers:  24ABD328;  55) REF LYN024CACSB, UDI/DI 40195327095735 (each), 10195327095734 (case), Lot Numbers:  23LBN673;  56) REF LYN030BCSDB, UDI/DI 40193489457965 (each), 10193489457964 (case), Lot Numbers:  24ABH583;  57) REF LYN030CPSSA, UDI/DI 40195327128549 (each), 10195327128548 (case), Lot Numbers:  23KBD385;  58) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers:  24ABA502;  59) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers:  23LBP443;  60) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers:  23LBQ089;  61) REF LYN030VAEYA, UDI/DI 40195327242917 (each), 10195327242916 (case), Lot Numbers:  24ABA893;  62) REF LYN030VAEYA, UDI/DI 40195327242917 (each), 10195327242916 (case), Lot Numbers:  24ABD329;  63) REF LYN035CTSEC, UDI/DI 40889942532026 (each), 10889942532025 (case), Lot Numbers:  23KBC621;  64) REF LYN037DBEYM, UDI/DI 40193489473910 (each), 10193489473919 (case), Lot Numbers:  23LBQ090;  65) REF LYN037DBEYM, UDI/DI 40193489473910 (each), 10193489473919 (case), Lot Numbers:  23KBD746;  66) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers:  24ABD867;  67) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers:  23LBN722;  68) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers:  23LBA842;  69) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers:  23KBD251;  70) REF LYN042CPFEG, UDI/DI 40193489219372 (each), 10193489219371 (case), Lot Numbers:  23KBC622;  71) REF PHS529724000B, UDI/DI 40195327166022 (each), 10195327166021 (case), Lot Numbers:  23KBE642;  72) REF VAL001CPMEB, UDI/DI 40195327205455 (each), 10195327205454 (case), Lot Numbers:  24ABE054;  73) REF VAL001CPMEB, UDI/DI 40195327205455 (each), 10195327205454 (case), Lot Numbers:  23LBH892;  74) REF VAL002CATSG, UDI/DI 40195327250417 (each), 10195327250416 (case), Lot Numbers:  24ABN974;  75) REF VAL002CATSG, UDI/DI 40195327250417 (each), 10195327250416 (case), Lot Numbers:  23KBC653;  76) REF VAL003REPEA, UDI/DI 40889942968382 (each), 10889942968381 (case), Lot Numbers:  24ABF774;  77) REF VAL009CAAHC, UDI/DI 40195327260300 (each), 10195327260309 (case), Lot Numbers:  23KBB402;  78) REF VAL009CAREA, UDI/DI 40193489462242 (each), 10193489462241 (case), Lot Numbers:  23KBC624;  79) REF VAL009CATEA, UDI/DI 40889942872399 (each), 10889942872398 (case), Lot Numbers:  24ABA924;  80) REF VAL009CTSGA, UDI/DI 40193489577540 (each), 10193489577549 (case), Lot Numbers:  24ABA478;  81) REF VAL009EYDLC, UDI/DI 40195327302291 (each), 10195327302290 (case), Lot Numbers:  24ABE052;  82) REF VAL009RETGA, UDI/DI 40193489676991 (each), 10193489676990 (case), Lot Numbers:  23LBQ654;  83) REF VAL009VIREA, UDI/DI 40193489462259 (each), 10193489462258 (case), Lot Numbers:  24ABA925;  84) REF VAL011CTVAA, UDI/DI 40889942005568 (each), 10889942005567 (case), Lot Numbers:  23KBC625;  85) REF VAL022BSOMD, UDI/DI 40889942760214 (each), 10889942760213 (case), Lot Numbers:  23LBQ097;  86) REF VAL024CAIOD, UDI/DI 40193489491525 (each), 10193489491524 (case), Lot Numbers:  23KBB700;  87) REF VAL024EYTRB, UDI/DI 40193489426008 (each), 10193489426007 (case), Lot Numbers:  23LBN467;  88) REF VAL026CTNFC, UDI/DI 40193489458412 (each), 10193489458411 (case), Lot Numbers:  23LBA843;  89) REF VAL029EYGSB, UDI/DI 40193489550727 (each), 10193489550726 (case), Lot Numbers:  23KBT152;  90) REF VAL031IOGCB, UDI/DI 40889942307198 (each), 10889942307197 (case), Lot Numbers:  24ABA898;  91) REF VAL035CPAEC, UDI/DI 40889942537373 (each), 10889942537372 (case), Lot Numbers:  23KBE643;  92) REF VAL036CABRD, UDI/DI 40195327196159 (each), 10195327196158 (case), Lot Numbers:  23KBC657;  93) REF VAL037ICBVG, UDI/DI 40193489868136 (each), 10193489868135 (case), Lot Numbers:  23KBC628;  94) REF VAL038BSCID, UDI/DI 40888277761767 (each), 10888277761766 (case), Lot Numbers:  23KBC629;  95) REF VAL038CTECB, UDI/DI 40889942867883 (each), 10889942867882 (case), Lot Numbers:  23LBP453;  96) REF VAL041EPSWA, UDI/DI 40193489394550 (each), 10193489394559 (case), Lot Numbers:  24ABA469;  97) REF VAL042EYBHC, UDI/DI 40195327033249 (each), 10195327033248 (case), Lot Numbers:  23KBD595;  98) REF VAL046CAWCA, UDI/DI 40193489846721 (each), 10193489846720 (case), Lot Numbers:  23LBM013;  99) REF VAL047VIVOA, UDI/DI 40193489375122 (each), 10193489375121 (case), Lot Numbers:  23LBM392;  100) REF VAL048TSCCA, UDI/DI 40195327250455 (each), 10195327250454 (case), Lot Numbers:  23LBQ099;  101) REF VAL048TSCCA, UDI/DI 40195327250455 (each), 10195327250454 (case), Lot Numbers:  23KBC660;  102) REF VAL050CTFEI, UDI/DI 40193489368063 (each), 10193489368062 (case), Lot Numbers:  24ABA899;  103) REF VAL050EEPKB, UDI/DI 40195327267149 (each), 10195327267148 (case), Lot Numbers:  24ABA472;  104) REF VAL050ITKEA, UDI/DI 40195327134090 (each), 10195327134099 (case), Lot Numbers:  23KBK068;  105) REF VAL050REBOB, UDI/DI 40193489833653 (each), 10193489833652 (case), Lot Numbers:  24ABA477;  106) REF VAL050VIAHD, UDI/DI 40195327195565 (each), 10195327195564 (case), Lot Numbers:  23JBU308;  107) REF VAL054CAMAA, UDI/DI 40193489228114 (each), 10193489228113 (case), Lot Numbers:  23LBQ100;  108) REF VAL059DKSWB, UDI/DI 40193489667951 (each), 10193489667950 (case), Lot Numbers:  23KBE384;  109) REF VAL075EYLSA, UDI/DI 40889942804345 (each), 10889942804344 (case), Lot Numbers:  23LBP466;  110) REF VAL089EYRUA, UDI/DI 40193489438162 (each), 10193489438161 (case), Lot Numbers:  23LBP468",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Panama.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}