{
  "@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-3049-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100;  2) LAVH CDS, Pack Number CDS760049AD;  3) LAVH CDS, Pack Number CDS760049AF;  4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ;  5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ;  6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ;  7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ;  8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ;  9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ;  10) LAVH CDS, Pack Number CDS920130K ;  11) LAVH PROCEDURE, Pack Number CDS980754R ;  12) LAVH PROCEDURE, Pack Number CDS980754S ;  13) VAG HYST KIT, Pack Number CDS981313L ;  14) VAG HYST KIT, Pack Number CDS981313M ;  15) MINOR LITHOTOMY , Pack Number CDS982037W ;  16) MAJOR LITHOTOMY , Pack Number CDS982052V ;  17) D&C CDS , Pack Number CDS982061K ;  18) LAVH, Pack Number CDS982273Q ;  19) LAVH, Pack Number CDS982273R ;  20) LAVH, Pack Number CDS982273S ;  21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ;  22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ;  23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ;  24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ;  25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ;  26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ;  27) VAGINAL MAJOR , Pack Number CDS982689S ;  28) VAGINAL MAJOR , Pack Number CDS982689T ;  29) GYN/ABDOMINAL , Pack Number CDS982725K ;  30) GYN/ABDOMINAL , Pack Number CDS982725N ;  31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ;  32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ;  33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ;  34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ;  35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ;  36) CUH LITHOTOMY CDS , Pack Number CDS983207M ;  37) CUH LITHOTOMY CDS , Pack Number CDS983207N ;  38) VAGINAL MINOR , Pack Number CDS983268I ;  39) LAVH CDS, Pack Number CDS983411I ;  40) LAVH CDS, Pack Number CDS983411J ;  41) LAVH CDS, Pack Number CDS983411K ;  42) LAVH PROCEDURE, Pack Number CDS983449L ;  43) LAVH PROCEDURE, Pack Number CDS983449M ;  44) LAVH PROCEDURE, Pack Number CDS983449N ;  45) LAVH CDS, Pack Number CDS983455C ;  46) MAJOR VAGINAL , Pack Number CDS983497J ;  47) MAJOR VAGINAL , Pack Number CDS983497L ;  48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ;  49) VAG HYST CDS, Pack Number CDS983697J ;  50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ;  51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ;  52) GYN MINOR CDS , Pack Number CDS983985G ;  53) GYN ABDOMINAL CDS , Pack Number CDS983988A ;  54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ;  55) TVT CDS , Pack Number CDS984091J ;  56) GROTH VAGINAL CDS , Pack Number CDS984201T ;  57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ;  58) GYN CDS , Pack Number CDS984676C ;  59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304;  60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ;  61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ;  62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ;  63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ;  64) MAJOR LITHOTOMY , Pack Number CDS985547N ;  65) PROCEDURE TRAY, Pack Number DYNDA2966;  66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ;  67) TVH TRAY, Pack Number DYNJ00460L ;  68) TVH TRAY, Pack Number DYNJ00460M ;  69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ;  70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ;  71) LAVH PACK-LF, Pack Number DYNJ00470K ;  72) LAVH PACK-LF, Pack Number DYNJ00470L ;  73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ;  74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ;  75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ;  76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ;  77) LAVH PACK-LF, Pack Number DYNJ0372824Q ;  78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ;  79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ;  80) VAGINAL HYSTERECTOMY PACK-",
  "description": "FDA recall Z-3049-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100;  2) LAVH CDS, Pack Number CDS760049AD;  3) LAVH CDS, Pack Number CDS760049AF;  4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ;  5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ;  6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ;  7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ;  8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ;  9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ;  10) LAVH CDS, Pack Number CDS920130K ;  11) LAVH PROCEDURE, Pack Number CDS980754R ;  12) LAVH PROCEDURE, Pack Number CDS980754S ;  13) VAG HYST KIT, Pack Number CDS981313L ;  14) VAG HYST KIT, Pack Number CDS981313M ;  15) MINOR LITHOTOMY , Pack Number CDS982037W ;  16) MAJOR LITHOTOMY , Pack Number CDS982052V ;  17) D&C CDS , Pack Number CDS982061K ;  18) LAVH, Pack Number CDS982273Q ;  19) LAVH, Pack Number CDS982273R ;  20) LAVH, Pack Number CDS982273S ;  21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ;  22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ;  23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ;  24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ;  25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ;  26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ;  27) VAGINAL MAJOR , Pack Number CDS982689S ;  28) VAGINAL MAJOR , Pack Number CDS982689T ;  29) GYN/ABDOMINAL , Pack Number CDS982725K ;  30) GYN/ABDOMINAL , Pack Number CDS982725N ;  31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ;  32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ;  33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ;  34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ;  35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ;  36) CUH LITHOTOMY CDS , Pack Number CDS983207M ;  37) CUH LITHOTOMY CDS , Pack Number CDS983207N ;  38) VAGINAL MINOR , Pack Number CDS983268I ;  39) LAVH CDS, Pack Number CDS983411I ;  40) LAVH CDS, Pack Number CDS983411J ;  41) LAVH CDS, Pack Number CDS983411K ;  42) LAVH PROCEDURE, Pack Number CDS983449L ;  43) LAVH PROCEDURE, Pack Number CDS983449M ;  44) LAVH PROCEDURE, Pack Number CDS983449N ;  45) LAVH CDS, Pack Number CDS983455C ;  46) MAJOR VAGINAL , Pack Number CDS983497J ;  47) MAJOR VAGINAL , Pack Number CDS983497L ;  48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ;  49) VAG HYST CDS, Pack Number CDS983697J ;  50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ;  51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ;  52) GYN MINOR CDS , Pack Number CDS983985G ;  53) GYN ABDOMINAL CDS , Pack Number CDS983988A ;  54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ;  55) TVT CDS , Pack Number CDS984091J ;  56) GROTH VAGINAL CDS , Pack Number CDS984201T ;  57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ;  58) GYN CDS , Pack Number CDS984676C ;  59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304;  60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ;  61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ;  62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ;  63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ;  64) MAJOR LITHOTOMY , Pack Number CDS985547N ;  65) PROCEDURE TRAY, Pack Number DYNDA2966;  66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ;  67) TVH TRAY, Pack Number DYNJ00460L ;  68) TVH TRAY, Pack Number DYNJ00460M ;  69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ;  70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ;  71) LAVH PACK-LF, Pack Number DYNJ00470K ;  72) LAVH PACK-LF, Pack Number DYNJ00470L ;  73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ;  74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ;  75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ;  76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ;  77) LAVH PACK-LF, Pack Number DYNJ0372824Q ;  78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ;  79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ;  80) VAGINAL HYSTERECTOMY PACK- (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-3049-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100;  2) LAVH CDS, Pack Number CDS760049AD;  3) LAVH CDS, Pack Number CDS760049AF;  4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ;  5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ;  6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ;  7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ;  8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ;  9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ;  10) LAVH CDS, Pack Number CDS920130K ;  11) LAVH PROCEDURE, Pack Number CDS980754R ;  12) LAVH PROCEDURE, Pack Number CDS980754S ;  13) VAG HYST KIT, Pack Number CDS981313L ;  14) VAG HYST KIT, Pack Number CDS981313M ;  15) MINOR LITHOTOMY , Pack Number CDS982037W ;  16) MAJOR LITHOTOMY , Pack Number CDS982052V ;  17) D&C CDS , Pack Number CDS982061K ;  18) LAVH, Pack Number CDS982273Q ;  19) LAVH, Pack Number CDS982273R ;  20) LAVH, Pack Number CDS982273S ;  21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ;  22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ;  23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ;  24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ;  25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ;  26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ;  27) VAGINAL MAJOR , Pack Number CDS982689S ;  28) VAGINAL MAJOR , Pack Number CDS982689T ;  29) GYN/ABDOMINAL , Pack Number CDS982725K ;  30) GYN/ABDOMINAL , Pack Number CDS982725N ;  31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ;  32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ;  33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ;  34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ;  35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ;  36) CUH LITHOTOMY CDS , Pack Number CDS983207M ;  37) CUH LITHOTOMY CDS , Pack Number CDS983207N ;  38) VAGINAL MINOR , Pack Number CDS983268I ;  39) LAVH CDS, Pack Number CDS983411I ;  40) LAVH CDS, Pack Number CDS983411J ;  41) LAVH CDS, Pack Number CDS983411K ;  42) LAVH PROCEDURE, Pack Number CDS983449L ;  43) LAVH PROCEDURE, Pack Number CDS983449M ;  44) LAVH PROCEDURE, Pack Number CDS983449N ;  45) LAVH CDS, Pack Number CDS983455C ;  46) MAJOR VAGINAL , Pack Number CDS983497J ;  47) MAJOR VAGINAL , Pack Number CDS983497L ;  48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ;  49) VAG HYST CDS, Pack Number CDS983697J ;  50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ;  51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ;  52) GYN MINOR CDS , Pack Number CDS983985G ;  53) GYN ABDOMINAL CDS , Pack Number CDS983988A ;  54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ;  55) TVT CDS , Pack Number CDS984091J ;  56) GROTH VAGINAL CDS , Pack Number CDS984201T ;  57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ;  58) GYN CDS , Pack Number CDS984676C ;  59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304;  60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ;  61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ;  62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ;  63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ;  64) MAJOR LITHOTOMY , Pack Number CDS985547N ;  65) PROCEDURE TRAY, Pack Number DYNDA2966;  66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ;  67) TVH TRAY, Pack Number DYNJ00460L ;  68) TVH TRAY, Pack Number DYNJ00460M ;  69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ;  70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ;  71) LAVH PACK-LF, Pack Number DYNJ00470K ;  72) LAVH PACK-LF, Pack Number DYNJ00470L ;  73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ;  74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ;  75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ;  76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ;  77) LAVH PACK-LF, Pack Number DYNJ0372824Q ;  78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ;  79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ;  80) VAGINAL HYSTERECTOMY PACK-",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3049-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3049-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100;  2) LAVH CDS, Pack Number CDS760049AD;  3) LAVH CDS, Pack Number CDS760049AF;  4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ;  5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ;  6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ;  7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ;  8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ;  9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ;  10) LAVH CDS, Pack Number CDS920130K ;  11) LAVH PROCEDURE, Pack Number CDS980754R ;  12) LAVH PROCEDURE, Pack Number CDS980754S ;  13) VAG HYST KIT, Pack Number CDS981313L ;  14) VAG HYST KIT, Pack Number CDS981313M ;  15) MINOR LITHOTOMY , Pack Number CDS982037W ;  16) MAJOR LITHOTOMY , Pack Number CDS982052V ;  17) D&C CDS , Pack Number CDS982061K ;  18) LAVH, Pack Number CDS982273Q ;  19) LAVH, Pack Number CDS982273R ;  20) LAVH, Pack Number CDS982273S ;  21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ;  22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ;  23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ;  24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ;  25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ;  26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ;  27) VAGINAL MAJOR , Pack Number CDS982689S ;  28) VAGINAL MAJOR , Pack Number CDS982689T ;  29) GYN/ABDOMINAL , Pack Number CDS982725K ;  30) GYN/ABDOMINAL , Pack Number CDS982725N ;  31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ;  32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ;  33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ;  34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ;  35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ;  36) CUH LITHOTOMY CDS , Pack Number CDS983207M ;  37) CUH LITHOTOMY CDS , Pack Number CDS983207N ;  38) VAGINAL MINOR , Pack Number CDS983268I ;  39) LAVH CDS, Pack Number CDS983411I ;  40) LAVH CDS, Pack Number CDS983411J ;  41) LAVH CDS, Pack Number CDS983411K ;  42) LAVH PROCEDURE, Pack Number CDS983449L ;  43) LAVH PROCEDURE, Pack Number CDS983449M ;  44) LAVH PROCEDURE, Pack Number CDS983449N ;  45) LAVH CDS, Pack Number CDS983455C ;  46) MAJOR VAGINAL , Pack Number CDS983497J ;  47) MAJOR VAGINAL , Pack Number CDS983497L ;  48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ;  49) VAG HYST CDS, Pack Number CDS983697J ;  50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ;  51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ;  52) GYN MINOR CDS , Pack Number CDS983985G ;  53) GYN ABDOMINAL CDS , Pack Number CDS983988A ;  54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ;  55) TVT CDS , Pack Number CDS984091J ;  56) GROTH VAGINAL CDS , Pack Number CDS984201T ;  57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ;  58) GYN CDS , Pack Number CDS984676C ;  59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304;  60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ;  61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ;  62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ;  63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ;  64) MAJOR LITHOTOMY , Pack Number CDS985547N ;  65) PROCEDURE TRAY, Pack Number DYNDA2966;  66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ;  67) TVH TRAY, Pack Number DYNJ00460L ;  68) TVH TRAY, Pack Number DYNJ00460M ;  69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ;  70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ;  71) LAVH PACK-LF, Pack Number DYNJ00470K ;  72) LAVH PACK-LF, Pack Number DYNJ00470L ;  73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ;  74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ;  75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ;  76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ;  77) LAVH PACK-LF, Pack Number DYNJ0372824Q ;  78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ;  79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ;  80) VAGINAL HYSTERECTOMY PACK-",
      "text": "The FDA logged enforcement record Z-3049-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100;  2) LAVH CDS, Pack Number CDS760049AD;  3) LAVH CDS, Pack Number CDS760049AF;  4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ;  5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ;  6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ;  7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ;  8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ;  9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ;  10) LAVH CDS, Pack Number CDS920130K ;  11) LAVH PROCEDURE, Pack Number CDS980754R ;  12) LAVH PROCEDURE, Pack Number CDS980754S ;  13) VAG HYST KIT, Pack Number CDS981313L ;  14) VAG HYST KIT, Pack Number CDS981313M ;  15) MINOR LITHOTOMY , Pack Number CDS982037W ;  16) MAJOR LITHOTOMY , Pack Number CDS982052V ;  17) D&C CDS , Pack Number CDS982061K ;  18) LAVH, Pack Number CDS982273Q ;  19) LAVH, Pack Number CDS982273R ;  20) LAVH, Pack Number CDS982273S ;  21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ;  22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ;  23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ;  24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ;  25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ;  26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ;  27) VAGINAL MAJOR , Pack Number CDS982689S ;  28) VAGINAL MAJOR , Pack Number CDS982689T ;  29) GYN/ABDOMINAL , Pack Number CDS982725K ;  30) GYN/ABDOMINAL , Pack Number CDS982725N ;  31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ;  32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ;  33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ;  34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ;  35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ;  36) CUH LITHOTOMY CDS , Pack Number CDS983207M ;  37) CUH LITHOTOMY CDS , Pack Number CDS983207N ;  38) VAGINAL MINOR , Pack Number CDS983268I ;  39) LAVH CDS, Pack Number CDS983411I ;  40) LAVH CDS, Pack Number CDS983411J ;  41) LAVH CDS, Pack Number CDS983411K ;  42) LAVH PROCEDURE, Pack Number CDS983449L ;  43) LAVH PROCEDURE, Pack Number CDS983449M ;  44) LAVH PROCEDURE, Pack Number CDS983449N ;  45) LAVH CDS, Pack Number CDS983455C ;  46) MAJOR VAGINAL , Pack Number CDS983497J ;  47) MAJOR VAGINAL , Pack Number CDS983497L ;  48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ;  49) VAG HYST CDS, Pack Number CDS983697J ;  50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ;  51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ;  52) GYN MINOR CDS , Pack Number CDS983985G ;  53) GYN ABDOMINAL CDS , Pack Number CDS983988A ;  54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ;  55) TVT CDS , Pack Number CDS984091J ;  56) GROTH VAGINAL CDS , Pack Number CDS984201T ;  57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ;  58) GYN CDS , Pack Number CDS984676C ;  59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304;  60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ;  61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ;  62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ;  63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ;  64) MAJOR LITHOTOMY , Pack Number CDS985547N ;  65) PROCEDURE TRAY, Pack Number DYNDA2966;  66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ;  67) TVH TRAY, Pack Number DYNJ00460L ;  68) TVH TRAY, Pack Number DYNJ00460M ;  69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ;  70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ;  71) LAVH PACK-LF, Pack Number DYNJ00470K ;  72) LAVH PACK-LF, Pack Number DYNJ00470L ;  73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ;  74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ;  75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ;  76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ;  77) LAVH PACK-LF, Pack Number DYNJ0372824Q ;  78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ;  79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ;  80) VAGINAL HYSTERECTOMY PACK- — 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: C040100, Lot Number 19BDB794 ;  C040100, Lot Number 19BDB938 ;  C040100, Lot Number 19CDD009 ;  C040100, Lot Number 19EDC262 ;  C040100, Lot Number 19EDC533 ;  C040100, Lot Number 19JDA569 ;  C040100, Lot Number 19JDA836 ;  C040100, Lot Number 19JDC293 ;  C040100, Lot Number 19LDB582 ;  C040100, Lot Number 20BDA227 ;  C040100, Lot Number 20BDA828 ;  C040100, Lot Number 20BDC639 ;  C040100, Lot Number 20DDA503 ;  C040100, Lot Number 20DDA627 ;  C040100, Lot Number 20HDC033 ;  C040100, Lot Number 21HDA277 ;  C040100, Lot Number 22EDB968 ;  C040100, Lot Number 22HDB951 ;  CDS760049AD, Lot Number 21IBC904 ;  CDS760049AD, Lot Number 21IBM329 ;  CDS760049AD, Lot Number 21LBS989 ;  CDS760049AD, Lot Number 22CBW119 ;  CDS760049AD, Lot Number 22OBL416 ;  CDS760049AD, Lot Number 22OBL970 ;  CDS760049AD, Lot Number 22GBD274 ;  CDS760049AD, Lot Number 22IBF092 ;  CDS760049AD, Lot Number 22JBF094 ;  CDS760049AD, Lot Number 22KBF472 ;  CDS760049AD, Lot Number 22KBI850 ;  CDS760049AD, Lot Number 23ABF834 ;  CDS760049AD, Lot Number 23BBK772 ;  CDS760049AD, Lot Number 23CBT560 ;  CDS760049AD, Lot Number 23EBO959 ;  CDS760049AD, Lot Number 23GBP399 ;  CDS760049AD, Lot Number 23GBT911 ;  CDS760049AD, Lot Number 23IBQ689 ;  CDS760049AD, Lot Number 23JBI109 ;  CDS760049AD, Lot Number 23KBD213 ;  CDS760049AF, Lot Number 23LBV054 ;  CDS760049AF, Lot Number 24ABR231 ;  CDS760056G , Lot Number 22BBZ815 ;  CDS760056G , Lot Number 22OBM631 ;  CDS760056G , Lot Number 22JBI460 ;  CDS760056G , Lot Number 23ABP479 ;  CDS760056G , Lot Number 23FBG175 ;  CDS760056G , Lot Number 23HBA191 ;  CDS760056G , Lot Number 23IBP582 ;  CDS760056G , Lot Number 23KBL445 ;  CDS760056G , Lot Number 23KBP697 ;  CDS760056G , Lot Number 24BBQ489 ;  CDS760088Q , Lot Number 19CBG116 ;  CDS760088Q , Lot Number 19DBG523 ;  CDS760088R , Lot Number 21GBS618 ;  CDS760088R , Lot Number 21HBB248 ;  CDS760088R , Lot Number 21IBP890 ;  CDS760088R , Lot Number 22OBM585 ;  CDS760088R , Lot Number 19UBA526 ;  CDS760088R , Lot Number 19JBX112 ;  CDS760088R , Lot Number 19VBB261 ;  CDS760088R , Lot Number 20BBZ171 ;  CDS760088R , Lot Number 20GBU569 ;  CDS760088R , Lot Number 20IBO653 ;  CDS760088R , Lot Number 20KBS815 ;  CDS760088R , Lot Number 20XBH134 ;  CDS760088S , Lot Number 22HMG145 ;  CDS760088S , Lot Number 22IMA901 ;  CDS760088S , Lot Number 22JMG651 ;  CDS830186P , Lot Number 22CBP266 ;  CDS830186P , Lot Number 22DBK431 ;  CDS830186P , Lot Number 22DBL618 ;  CDS830186R , Lot Number 22FBR813 ;  CDS830186R , Lot Number 22HBD852 ;  CDS830186R , Lot Number 22IBA199 ;  CDS920130K , Lot Number 23HME492 ;  CDS920130K , Lot Number 23HME823 ;  CDS920130K , Lot Number 23HMH121 ;  CDS920130K , Lot Number 23IMF884 ;  CDS980754R , Lot Number 23BMB975 ;  CDS980754R , Lot Number 23BMC711 ;  CDS980754S , Lot Number 23KMC281 ;  CDS980754S , Lot Number 23KMG518 ;  CDS980754S , Lot Number 23LMH962 ;  CDS980754S , Lot Number 24AMG691 ;  CDS980754S , Lot Number 24BMC635 ;  CDS981313L , Lot Number 19ABX762 ;  CDS981313L , Lot Number 19DBA731 ;  CDS981313L , Lot Number 19EBY373 ;  CDS981313L , Lot Number 19HBI633 ;  CDS981313L , Lot Number 19JBT845 ;  CDS981313L , Lot Number 20MBA368 ;  CDS981313L , Lot Number 20CBR992 ;  CDS981313L , Lot Number 20DBG990 ;  CDS981313M , Lot Number 20IBD346 ;  CDS981313M , Lot Number 20KBA286 ;  CDS981313M , Lot Number 20KBU978 ;  CDS981313M , Lot Number 20LBP521 ;  CDS981313M , Lot Number 21CBA228 ;  CDS981313M , Lot Number 21DBP142 ;  CDS982037W , Lot Number 21LBF070 ;  CDS982037W , Lot Number 22BBM902 ;  CDS982037W , Lot Number 22BBR660 ;  CDS982037W , Lot Number 22FBG184 ;  CDS982037W , Lot Number 22FBR768 ;  CDS982037W , Lot Number 22IBD070 ;  CDS982037W , Lot Number 22KBS697 ;  CDS982037W , Lot Number 23ABQ939 ;  CDS982037W , Lot Number 23CBO799 ;  CDS982037W , Lot Number 23EBN594 ;  CDS982037W , Lot Number 23HBJ195 ;  CDS982037W , Lot Number 23HBJ605 ;  CDS982037W , Lot Number 23IBW115 ;  CDS982037W , Lot Number 23JBV056 ;  CDS982037W , Lot Number 23KMJ836 ;  CDS982037W , Lot Number 24AMH567 ;  CDS982052V , Lot Number 21KBZ649 ;  CDS982052V , Lot Number 22ABF202 ;  CDS982052V , Lot Number 22HBX588 ;  CDS982052V , Lot Number 22JBU113 ;  CDS982052V , Lot Number 22JBU116 ;  CDS982052V , Lot Number 23CBD752 ;  CDS982052V , Lot Number 23CBE945 ;  CDS982052V , Lot Number 23DBT193 ;  CDS982052V , Lot Number 23HBQ538 ;  CDS982052V , Lot Number 23IBW102 ;  CDS982052V , Lot Number 23KMI312 ;  CDS982052V , Lot Number 23LMD879 ;  CDS982061K , Lot Number 21IBW856 ;  CDS982061K , Lot Number 21KBS274 ;  CDS982061K , Lot Number 22OBE737 ;  CDS982061K , Lot Number 22EBA703 ;  CDS982061K , Lot Number 22FBV543 ;  CDS982061K , Lot Number 22HBS449 ;  CDS982061K , Lot Number 22KBP046 ;  CDS982061K , Lot Number 22KBP047 ;  CDS982061K , Lot Number 22LBC347 ;  CDS982061K , Lot Number 23ABQ969 ;  CDS982061K , Lot Number 23BBG722 ;  CDS982061K , Lot Number 23DBM366 ;  CDS982061K , Lot Number 23HBA225 ;  CDS982061K , Lot Number 23IBQ685 ;  CDS982061K , Lot Number 23KBA714 ;  CDS982061K , Lot Number 23KBM514 ;  CDS982061K , Lot Number 23LBE801 ;  CDS982061K , Lot Number 24ABV338 ;  CDS982273Q , Lot Number 21IBU101 ;  CDS982273Q , Lot Number 21EBO708 ;  CDS982273R , Lot Number 21LBN096 ;  CDS982273R , Lot Number 22ABK139 ;  CDS982273R , Lot Number 22DBH928 ;  CDS982273R , Lot Number 22GBU467 ;  CDS982273R , Lot Number 22IBD391 ;  CDS982273S , Lot Number 22JBB430 ;  CDS982273S , Lot Number 22KBN716 ;  CDS982273S , Lot Number 23ABA723 ;  CDS982273S , Lot Number 23BBE856 ;  CDS982273S , Lot Number 23BBL720 ;  CDS982273S , Lot Number 23CBH328 ;  CDS982273S , Lot Number 23CBH329 ;  CDS982273S , Lot Number 23EBV674 ;  CDS982273S , Lot Number 23IBN696 ;  CDS982273S , Lot Number 24AMG278 ;  CDS982273S , Lot Number 24BMA347 ;  CDS982273S , Lot Number 24CMD457 ;  CDS982397C , Lot Number 21JBU214 ;  CDS982397C , Lot Number 22IBN506 ;  CDS982397C , Lot Number 22KBU542 ;  CDS982397C , Lot Number 23BBP206 ;  CDS982397C , Lot Number 23BBP325 ;  CDS982397C , Lot Number 23EBR453 ;  CDS982397C , Lot Number 23FBH064 ;  CDS982397C , Lot Number 23IBQ686 ;  CDS982397C , Lot Number 24ABS956 ;  CDS982397C , Lot Number 24ABW938 ;  CDS982602K , Lot Number 21GBL322 ;  CDS982602K , Lot Number 21HBM038 ;  CDS982602K , Lot Number 21IBJ332 ;  CDS982602K , Lot Number 22ABV534 ;  CDS982602K , Lot Number 19BBM165 ;  CDS982602K , Lot Number 19BBN150 ;  CDS982602K , Lot Number 22OBA636 ;  CDS982602K , Lot Number 22GBR159 ;  CDS982602K , Lot Number 19GBS396 ;  CDS982602K , Lot Number 22IBF211 ;  CDS982602K , Lot Number 22LBA931 ;  CDS982602K , Lot Number 19JBK239 ;  CDS982602K , Lot Number 23ABE334 ;  CDS982602K , Lot Number 23BBG612 ;  CDS982602K , Lot Number 19KBP405 ;  CDS982602K , Lot Number 19LBH109 ;  CDS982602K , Lot Number 23DBD808 ;  CDS982602K , Lot Number 23GBD747 ;  CDS982602K , Lot Number 20EBE506 ;  CDS982602K , Lot Number 23IBG234 ;  CDS982602K , Lot Number 20FBF620 ;  CDS982602K , Lot Number 23LBB669 ;  CDS982602K , Lot Number 20JBO075 ;  CDS982602K , Lot Number 21EBG429 ;  CDS982602K , Lot Number 21FBD431 ;  CDS982662P , Lot Number 21GBC730 ;  CDS982662P , Lot Number 21HBH174 ;  CDS982662P , Lot Number 21IBK126 ;  CDS982662P , Lot Number 21JBK680 ;  CDS982662P , Lot Number 21JBK682 ;  CDS982662P , Lot Number 21LBC637 ;  CDS982662P , Lot Number 22BBT806 ;  CDS982662P , Lot Number 22EBQ398 ;  CDS982662P , Lot Number 22EBR469 ;  CDS982662P , Lot Number 22HBJ982 ;  CDS982662P , Lot Number 22HBO573 ;  CDS982662P , Lot Number 22JBC944 ;  CDS982662P , Lot Number 22KBF419 ;  CDS982662P , Lot Number 21DBM295 ;  CDS982662Q , Lot Number 22LBF241 ;  CDS982662Q , Lot Number 23ABF502 ;  CDS982662Q , Lot Number 23ABQ625 ;  CDS982662Q , Lot Number 23ABQ898 ;  CDS982662Q , Lot Number 23CBG926 ;  CDS982662Q , Lot Number 23EBT047 ;  CDS982662Q , Lot Number 23FBH710 ;  CDS982662Q , Lot Number 23GBA671 ;  CDS982662Q , Lot Number 23HBH860 ;  CDS982662Q , Lot Number 23JBN205 ;  CDS982662Q , Lot Number 23KBA263 ;  CDS982662Q , Lot Number 24ABD449 ;  CDS982662Q , Lot Number 24BBI130 ;  CDS982669N , Lot Number 21LME808 ;  CDS982679M , Lot Number 22EMH019 ;  CDS982679M , Lot Number 23BMG387 ;  CDS982679M , Lot Number 23EMG515 ;  CDS982679M , Lot Number 24AMC003 ;  CDS982679M , Lot Number 24AMI864 ;  CDS982689S , Lot Number 22GBO302 ;  CDS982689S , Lot Number 22GBY989 ;  CDS982689T , Lot Number 22GBU291 ;  CDS982689T , Lot Number 22KBJ850 ;  CDS982689T , Lot Number 23BBD125 ;  CDS982689T , Lot Number 23BBU796 ;  CDS982689T , Lot Number 23DBH809 ;  CDS982689T , Lot Number 23EBS633 ;  CDS982689T , Lot Number 23FBL128 ;  CDS982689T , Lot Number 23HBA563 ;  CDS982689T , Lot Number 23JBQ209 ;  CDS982689T , Lot Number 23KBV521 ;  CDS982689T , Lot Number 24BBB731 ;  CDS982689T , Lot Number 24BBI100 ;  CDS982725K , Lot Number 19BBK882 ;  CDS982725K , Lot Number 19PBC866 ;  CDS982725K , Lot Number 19HBE488 ;  CDS982725N , Lot Number 22HBE143 ;  CDS982725N , Lot Number 22JBA911 ;  CDS982907J , Lot Number 19BBA745 ;  CDS982907J , Lot Number 19CBN622 ;  CDS982907J , Lot Number 19QBA097 ;  CDS982907J , Lot Number 19QBA253 ;  CDS982907J , Lot Number 19FBO233 ;  CDS982907J , Lot Number 19IBI935 ;  CDS982907J , Lot Number 19JBT828 ;  CDS982907J , Lot Number 19KBM272 ;  CDS982907J , Lot Number 20BBK775 ;  CDS982907J , Lot Number 20DBA250 ;  CDS982907M , Lot Number 21HBR367 ;  CDS982907M , Lot Number 21HBR368 ;  CDS982907M , Lot Number 21KBA489 ;  CDS982907M , Lot Number 22ABD376 ;  CDS982907M , Lot Number 22OBK811 ;  CDS982907M , Lot Number 22FBP710 ;  CDS982907M , Lot Number 22GBN825 ;  CDS982907M , Lot Number 22JBJ236 ;  CDS982907M , Lot Number 22JBJ379 ;  CDS982907M , Lot Number 22LBR862 ;  CDS982907M , Lot Number 23ABE669 ;  CDS982907M , Lot Number 23BBQ651 ;  CDS983006D , Lot Number 21VBA175 ;  CDS983006D , Lot Number 21KBK350 ;  CDS983006D , Lot Number 21KBS261 ;  CDS983006D , Lot Number 22ABB427 ;  CDS983006D , Lot Number 19BBE425 ;  CDS983006D , Lot Number 19DBP353 ;  CDS983006D , Lot Number 19QBA709 ;  CDS983006D , Lot Number 19SBE907 ;  CDS983006D , Lot Number 23ABN677 ;  CDS983006D , Lot Number 23BBG575 ; 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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-3049-2024&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-3049-2024&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-3049-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3049-2024 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-3049-2024&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-3049-2024&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-3049-2024/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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 DYNJ0415760O , Lot Number 21FME803 ;  DYNJ0415760O , Lot Number 21GMD590 ;  DYNJ0415760O , Lot Number 21IMF889 ;  DYNJ0415760O , Lot Number 21LMF717 ;  DYNJ0415760O , Lot Number 22BMB830 ;  DYNJ0415760O , Lot Number 22FMB785 ;  DYNJ0415760O , Lot Number 22HMG347 ;  DYNJ0415760O , Lot Number 22JMH873 ;  DYNJ0415760O , Lot Number 23BMG967 ;  DYNJ0415760O , Lot Number 23DMB532 ;  DYNJ0415760O , Lot Number 23FMA226 ;  DYNJ0415760O , Lot Number 23HMH707 ;  DYNJ0415760O , Lot Number 23IMG049 ;  DYNJ0415760O , Lot Number 23JMC003 ;  DYNJ0415941I , Lot Number 19AKD285 ;  DYNJ0415941I , Lot Number 19CKD631 ;  DYNJ0415941I , Lot Number 19EKC543 ;  DYNJ0415941I , Lot Number 19GKB045 ;  DYNJ0416529R , Lot Number 19BBF220 ;  DYNJ0416529R , Lot Number 19CBG029 ;  DYNJ0416529R , Lot Number 19CBN259 ;  DYNJ0416529R , Lot Number 19QBC234 ;  DYNJ0416529R , Lot Number 19TBC130 ;  DYNJ0416529V , Lot Number 21GBH153 ;  DYNJ0416529V , Lot Number 21GBS970 ;  DYNJ0416529V , Lot Number 21HBM359 ;  DYNJ0416529V , Lot Number 21JBW225 ;  DYNJ0416529V , Lot Number 22DBG622 ;  DYNJ0416529V , Lot Number 22LBQ458 ;  DYNJ0416529V , Lot Number 21DBW409 ;  DYNJ0416529V , Lot Number 21EBF296 ;  DYNJ0416529W , Lot Number 23CBB975 ;  DYNJ0416529W , Lot Number 23FBQ639 ;  DYNJ0416529W , Lot Number 23HBM997 ;  DYNJ0416529W , Lot Number 23JBK763 ;  DYNJ0416529W , Lot Number 23KBI381 ;  DYNJ0425778L , Lot Number 21HBB424 ;  DYNJ0425778M , Lot Number 22FMC747 ;  DYNJ0425778M , Lot Number 22HMH702 ;  DYNJ0425778M , Lot Number 22IMH817 ;  DYNJ0425778M , Lot Number 23AMG986 ;  DYNJ0425778M , Lot Number 23AMI251 ;  DYNJ0425778M , Lot Number 23CMD844 ;  DYNJ0425778M , Lot Number 23DMF717 ;  DYNJ0425778M , Lot Number 23EMD230 ;  DYNJ0425778M , Lot Number 23FMF089 ;  DYNJ0425778M , Lot Number 23GMG780 ;  DYNJ0425778M , Lot Number 23IME073 ;  DYNJ0425778M , Lot Number 23JMB733 ;  DYNJ0425778M , Lot Number 21KLB153 ;  DYNJ0425778M , Lot Number 21LLA348 ;  DYNJ0425778M , Lot Number 22BLA746 ;  DYNJ0425778M , Lot Number 22BLB130 ;  DYNJ0425778M , Lot Number 22CLA896 ;  DYNJ0425778M , Lot Number 22DLB089 ;  DYNJ04691R , Lot Number 23DMI418 ;  DYNJ04691R , Lot Number 23FMJ033 ;  DYNJ04691R , Lot Number 23HMA043 ;  DYNJ04691R , Lot Number 23IMF726 ;  DYNJ04691R , Lot Number 23IMG335 ;  DYNJ04840P , Lot Number 23HMA594 ;  DYNJ04840P , Lot Number 23HME117 ;  DYNJ0532873L , Lot Number 21IMG118 ;  DYNJ0532873M , Lot Number 22FMH645 ;  DYNJ0532873M , Lot Number 22GMG335 ;  DYNJ0532873M , Lot Number 22HMF692 ;  DYNJ0532873N , Lot Number 23DMD053 ;  DYNJ0537688AJ, Lot Number 21IMC191 ;  DYNJ0537688AK, Lot Number 21LMC572 ;  DYNJ0537688AK, Lot Number 22BME495 ;  DYNJ0537688AK, Lot Number 22CMC314 ;  DYNJ0537688AK, Lot Number 22EMF228 ;  DYNJ0537688AK, Lot Number 22FMA707 ;  DYNJ0537688AK, Lot Number 22IMC902 ;  DYNJ0537688AK, Lot Number 22JMH184 ;  DYNJ0537688AK, Lot Number 23AMI379 ;  DYNJ0537688AK, Lot Number 23CMA399 ;  DYNJ0537688AK, Lot Number 23EMF818 ;  DYNJ0537688AK, Lot Number 23FMI973 ;  DYNJ0537688AK, Lot Number 23GMI233 ;  DYNJ0537688AK, Lot Number 23IMF258 ;  DYNJ0537688AK, Lot Number 23JMJ374 ;  DYNJ0537688AK, Lot Number 23KMG879 ;  DYNJ0537688AK, Lot Number 23LMG034 ;  DYNJ0547084L , Lot Number 19AKD146 ;  DYNJ0547084L , Lot Number 19CKB258 ;  DYNJ0547084L , Lot Number 19EKC623 ;  DYNJ0547084O , Lot Number 21EMD315 ;  DYNJ0547084O , Lot Number 21FMB952 ;  DYNJ0547084O , Lot Number 21GMB909 ;  DYNJ0547084O , Lot Number 21HMA371 ;  DYNJ0547084O , Lot Number 21HME779 ;  DYNJ0547084O , Lot Number 21JMD912 ;  DYNJ0547084O , Lot Number 22AMC898 ;  DYNJ0547084O , Lot Number 22CMF119 ;  DYNJ0547084O , Lot Number 22FMB324 ;  DYNJ0547084O , Lot Number 22KMB706 ;  DYNJ0547084O , Lot Number 22LMJ300 ;  DYNJ0547084O , Lot Number 23CMC442 ;  DYNJ0547084O , Lot Number 23DMG212 ;  DYNJ0547084O , Lot Number 23FMD877 ;  DYNJ0547084O , Lot Number 23HMC128 ;  DYNJ0547084O , Lot Number 23KME941 ;  DYNJ0549338P , Lot Number 19EBP202 ;  DYNJ0549338P , Lot Number 19HBJ318 ;  DYNJ0549338P , Lot Number 19IBZ196 ;  DYNJ0549338P , Lot Number 19VBB543 ;  DYNJ0549338P , Lot Number 19KBZ332 ;  DYNJ0549338P , Lot Number 20CBV163 ;  DYNJ0549338P , Lot Number 20IMC699 ;  DYNJ0549338P , Lot Number 20JME852 ;  DYNJ0549338P , Lot Number 21AMC109 ;  DYNJ0549338P , Lot Number 21DMD917 ;  DYNJ0549338P , Lot Number 21FMA594 ;  DYNJ0549338P , Lot Number 21GMB569 ;  DYNJ0549338P , Lot Number 21IMB941 ;  DYNJ0549338P , Lot Number 21KMH919 ;  DYNJ0549338P , Lot Number 19AKD619 ;  DYNJ0549338P , Lot Number 19CKC615 ;  DYNJ0549338Q , Lot Number 22AME260 ;  DYNJ0549338Q , Lot Number 22BMA078 ;  DYNJ0549338Q , Lot Number 22CMD353 ;  DYNJ0549338Q , Lot Number 22DME990 ;  DYNJ0549338Q , Lot Number 22GMF448 ;  DYNJ0549338Q , Lot Number 22HME393 ;  DYNJ0549338Q , Lot Number 22KMD553 ;  DYNJ0549338Q , Lot Number 22LMF900 ;  DYNJ0549338Q , Lot Number 23AMF896 ;  DYNJ0549338Q , Lot Number 23CMA819 ;  DYNJ0549338Q , Lot Number 23DME381 ;  DYNJ0549338Q , Lot Number 23EMD924 ;  DYNJ0549338R , Lot Number 23FMG142 ;  DYNJ0549338R , Lot Number 23HMD655 ;  DYNJ0549338R , Lot Number 23JMG106 ;  DYNJ0565537P , Lot Number 18LBN971 ;  DYNJ0565537P , Lot Number 19ABP800 ;  DYNJ0565537P , Lot Number 19BBR938 ;  DYNJ0565537P , Lot Number 19FBG872 ;  DYNJ0565537P , Lot Number 19GBS081 ;  DYNJ0565543T , Lot Number 21GMB444 ;  DYNJ0565543T , Lot Number 21HMG874 ;  DYNJ0565543T , Lot Number 21IMG019 ;  DYNJ0565543T , Lot Number 21JMC883 ;  DYNJ0565543T , Lot Number 21JME321 ;  DYNJ0565543T , Lot Number 21LME868 ;  DYNJ0565543T , Lot Number 22AMD950 ;  DYNJ0565543T , Lot Number 22BMF057 ;  DYNJ0565543T , Lot Number 22CMJ026 ;  DYNJ0565543T , Lot Number 22EMF502 ;  DYNJ0565543T , Lot Number 22FMG518 ;  DYNJ0565543T , Lot Number 22IMC903 ;  DYNJ0565543T , Lot Number 22JMC082 ;  DYNJ0565543T , Lot Number 22LMC782 ;  DYNJ0565543T , Lot Number 23AMA802 ;  DYNJ0565543T , Lot Number 23CMC206 ;  DYNJ0565543T , Lot Number 23EMA571 ;  DYNJ0565543T , Lot Number 23EMG752 ;  DYNJ0565543T , Lot Number 23FME852 ;  DYNJ0597304L , Lot Number 20GMB814 ;  DYNJ0597304L , Lot Number 20GMC612 ;  DYNJ0597304L , Lot Number 20IMC059 ;  DYNJ0597304L , Lot Number 20LMC228 ;  DYNJ0597304L , Lot Number 21IMH102 ;  DYNJ0597304L , Lot Number 22AMD735 ;  DYNJ0597304L , Lot Number 22AMG030 ;  DYNJ0597304L , Lot Number 22GMH822 ;  DYNJ0597304L , Lot Number 22KMC193 ;  DYNJ0597304L , Lot Number 23BMH400 ;  DYNJ0597304L , Lot Number 23GME300 ;  DYNJ0665086F , Lot Number 21IBG229 ;  DYNJ0665086F , Lot Number 21LBG696 ;  DYNJ0665086F , Lot Number 22ABJ222 ;  DYNJ0665086F , Lot Number 22DBK166 ;  DYNJ0665086F , Lot Number 22EBG377 ;  DYNJ0665086F , Lot Number 22FBJ595 ;  DYNJ0665086F , Lot Number 22IBT460 ;  DYNJ0665086F , Lot Number 22LBQ460 ;  DYNJ0665086F , Lot Number 23BBI587 ;  DYNJ0665086F , Lot Number 23DBJ034 ;  DYNJ0665086F , Lot Number 23EBP148 ;  DYNJ0665086F , Lot Number 23GBS960 ;  DYNJ0665086F , Lot Number 23IBC521 ;  DYNJ0665086F , Lot Number 23IBU386 ;  DYNJ0665086F , Lot Number 23JBW085 ;  DYNJ0665086F , Lot Number 20KBK990 ;  DYNJ0665086F , Lot Number 20XBC194 ;  DYNJ0665086F , Lot Number 20XBG915 ;  DYNJ0665086F , Lot Number 21CBX234 ;  DYNJ0665086G , Lot Number 23LBA535 ;  DYNJ0665427D , Lot Number 19ABN671 ;  DYNJ0665427D , Lot Number 19DBR158 ;  DYNJ0665427D , Lot Number 19RBC395 ;  DYNJ0665427D , Lot Number 19IBD701 ;  DYNJ0665427D , Lot Number 19KBF018 ;  DYNJ0665427D , Lot Number 20ABT374 ;  DYNJ0665427D , Lot Number 20BBV459 ;  DYNJ0665427D , Lot Number 20DBS488 ;  DYNJ0665427F , Lot Number 21IBU033 ;  DYNJ0665427F , Lot Number 21KBD788 ;  DYNJ0665427F , Lot Number 22ABA612 ;  DYNJ0665427F , Lot Number 22EBI819 ;  DYNJ0665427F , Lot Number 23ABM288 ;  DYNJ0665427F , Lot Number 23EBU598 ;  DYNJ0665427F , Lot Number 23GBI799 ;  DYNJ0665427F , Lot Number 23HBA968 ;  DYNJ0665427F , Lot Number 23JBJ762 ;  DYNJ0665427F , Lot Number 20LBO555 ;  DYNJ0665427F , Lot Number 20LBR905 ;  DYNJ0665427F , Lot Number 21BBE572 ;  DYNJ0665427F , Lot Number 21CBX245 ;  DYNJ0665427G , Lot Number 23KBS318 ;  DYNJ0705988J , Lot Number 23EMJ179 ;  DYNJ0705988J , Lot Number 23HMD657 ;  DYNJ0750737P , Lot Number 21JMA356 ;  DYNJ0750737P , Lot Number 22AMA386 ;  DYNJ0750737P , Lot Number 22BME445 ;  DYNJ0750737P , Lot Number 22BMH105 ;  DYNJ0750737P , Lot Number 22CMF097 ;  DYNJ0750737Q , Lot Number 23DMF402 ;  DY",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}