{
  "@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-3016-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) CHEST EXPLORATION CDS , Pack Number CDS920066K ;  2) CHEST EXPLORATION CDS , Pack Number CDS920066L ;  3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ;  4) PLASTICS, Pack Number CDS980200AA;  5) PLASTICS, Pack Number CDS980200Y ;  6) BREAST/MINOR, Pack Number CDS980228W ;  7) PLASTIC CDS , Pack Number CDS980232U ;  8) PLASTIC CDS , Pack Number CDS980232V ;  9) PLASTIC CDS , Pack Number CDS980232W ;  10) PLASTIC CDS , Pack Number CDS980232X ;  11) LTP CDS-LF, Pack Number CDS980375L ;  12) PLASTIC CDS , Pack Number CDS980457R ;  13) PLASTIC CDS , Pack Number CDS980457S ;  14) PLASTIC CDS , Pack Number CDS980457T ;  15) BREAST AUG, Pack Number CDS980567R ;  16) BREAST AUG, Pack Number CDS980567S ;  17) LARGE PROCEDURE-LF, Pack Number CDS981257J ;  18) LARGE PROCEDURE-LF, Pack Number CDS981257K ;  19) BREAST CDS, Pack Number CDS981691N ;  20) MAJOR PLASTICS CDS, Pack Number CDS981958I ;  21) MAJOR PLASTIC CDS-LF, Pack Number CDS981978J ;  22) MINOR PLASTIC , Pack Number CDS982018K ;  23) MAJOR BREAST, Pack Number CDS982038S ;  24) VASAL RECONSTRUCTION, Pack Number CDS982042O ;  25) MINOR BREAST, Pack Number CDS982053M ;  26) MINOR BREAST, Pack Number CDS982053N ;  27) MINOR BREAST, Pack Number CDS982053O ;  28) MINOR BREAST, Pack Number CDS982053P ;  29) BREAST AUGMENTATION , Pack Number CDS982254K ;  30) BREAST AUGMENTATION , Pack Number CDS982254L ;  31) BREAST AUGMENTATION , Pack Number CDS982254M ;  32) BREAST REDUCTION CDS, Pack Number CDS982255G ;  33) BREAST REDUCTION CDS, Pack Number CDS982255I ;  34) BREAST REDUCTION, Pack Number CDS982255J ;  35) TYMPANOPLASTY , Pack Number CDS982720M ;  36) MAJOR BREAST CDS SJF-LF , Pack Number CDS982730M ;  37) REDUCTION CDS , Pack Number CDS982776J ;  38) REDUCTION CDS , Pack Number CDS982776K ;  39) REDUCTION CDS , Pack Number CDS982776L ;  40) HMT MAJOR BREAST/PLASTICS CDS , Pack Number CDS982860R ;  41) MAG PLASTIC CDS , Pack Number CDS982909I ;  42) MAG PLASTIC CDS , Pack Number CDS982909J ;  43) MAG PLASTIC CDS , Pack Number CDS982909K ;  44) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910K ;  45) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910L ;  46) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910M ;  47) MAG FREE FLAP CDS-LF, Pack Number CDS982911K ;  48) GENERAL BREAST, Pack Number CDS983058G ;  49) GENERAL BREAST, Pack Number CDS983058I ;  50) BASIC PLASTIC CDS-LF, Pack Number CDS983141C ;  51) BASIC PLASTIC CDS-LF, Pack Number CDS983141D ;  52) BREAST CDS, Pack Number CDS983148A ;  53) BREAST CDS, Pack Number CDS983148B ;  54) ZALE STEREOTACTIC CDS , Pack Number CDS983173I ;  55) CUH ABDOMINOPLASTY CDS, Pack Number CDS983176I ;  56) MAJOR CDS , Pack Number CDS983292D ;  57) PECTUS REPAIR , Pack Number CDS983353R ;  58) PECTUS REPAIR , Pack Number CDS983353S ;  59) PECTUS REPAIR , Pack Number CDS983353T ;  60) PECTUS REPAIR , Pack Number CDS983353U ;  61) PECTUS REPAIR , Pack Number CDS983353V ;  62) PECTUS REPAIR , Pack Number CDS983353X ;  63) MAMMOPLASTY-LF, Pack Number CDS983478J ;  64) MAMMOPLASTY-LF, Pack Number CDS983478K ;  65) MAMMOPLASTY-LF, Pack Number CDS983478L ;  66) PLASTICS FREE FLAP, Pack Number CDS983493L;  67) PLASTICS FREE FLAP, Pack Number CDS983493M;  68) PLASTIC TORSO-LF, Pack Number CDS983496I ;  69) PLASTIC TORSO-LF, Pack Number CDS983496J ;  70) PLASTIC TORSO-LF, Pack Number CDS983496K ;  71) PLASTIC TORSO-LF, Pack Number CDS983496L ;  72) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498I ;  73) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498J ;  74) ACH PLASTICS BREAST-LF, Pack Number CDS983639C ;  75) ACH PLASTICS BREAST-LF, Pack Number CDS983639D ;  76) ACH PLASTICS BREAST-LF, Pack Number CDS983639G ;  77) ACH PLASTICS BREAST-LF, Pack Number CDS983639I ;  78) ACH PLASTICS BREAST-LF, Pack Number CDS983639J ;  79) ACH PLASTICS BREAST-LF, Pack Number CDS983639K ;  80) NE BREAST AUGMENTATION CDS, Pack Number CDS983660C ;  81) NE BREAST RECON CDS , Pack Number CDS983660D ;  82) NE BREAST RECON",
  "description": "FDA recall Z-3016-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) CHEST EXPLORATION CDS , Pack Number CDS920066K ;  2) CHEST EXPLORATION CDS , Pack Number CDS920066L ;  3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ;  4) PLASTICS, Pack Number CDS980200AA;  5) PLASTICS, Pack Number CDS980200Y ;  6) BREAST/MINOR, Pack Number CDS980228W ;  7) PLASTIC CDS , Pack Number CDS980232U ;  8) PLASTIC CDS , Pack Number CDS980232V ;  9) PLASTIC CDS , Pack Number CDS980232W ;  10) PLASTIC CDS , Pack Number CDS980232X ;  11) LTP CDS-LF, Pack Number CDS980375L ;  12) PLASTIC CDS , Pack Number CDS980457R ;  13) PLASTIC CDS , Pack Number CDS980457S ;  14) PLASTIC CDS , Pack Number CDS980457T ;  15) BREAST AUG, Pack Number CDS980567R ;  16) BREAST AUG, Pack Number CDS980567S ;  17) LARGE PROCEDURE-LF, Pack Number CDS981257J ;  18) LARGE PROCEDURE-LF, Pack Number CDS981257K ;  19) BREAST CDS, Pack Number CDS981691N ;  20) MAJOR PLASTICS CDS, Pack Number CDS981958I ;  21) MAJOR PLASTIC CDS-LF, Pack Number CDS981978J ;  22) MINOR PLASTIC , Pack Number CDS982018K ;  23) MAJOR BREAST, Pack Number CDS982038S ;  24) VASAL RECONSTRUCTION, Pack Number CDS982042O ;  25) MINOR BREAST, Pack Number CDS982053M ;  26) MINOR BREAST, Pack Number CDS982053N ;  27) MINOR BREAST, Pack Number CDS982053O ;  28) MINOR BREAST, Pack Number CDS982053P ;  29) BREAST AUGMENTATION , Pack Number CDS982254K ;  30) BREAST AUGMENTATION , Pack Number CDS982254L ;  31) BREAST AUGMENTATION , Pack Number CDS982254M ;  32) BREAST REDUCTION CDS, Pack Number CDS982255G ;  33) BREAST REDUCTION CDS, Pack Number CDS982255I ;  34) BREAST REDUCTION, Pack Number CDS982255J ;  35) TYMPANOPLASTY , Pack Number CDS982720M ;  36) MAJOR BREAST CDS SJF-LF , Pack Number CDS982730M ;  37) REDUCTION CDS , Pack Number CDS982776J ;  38) REDUCTION CDS , Pack Number CDS982776K ;  39) REDUCTION CDS , Pack Number CDS982776L ;  40) HMT MAJOR BREAST/PLASTICS CDS , Pack Number CDS982860R ;  41) MAG PLASTIC CDS , Pack Number CDS982909I ;  42) MAG PLASTIC CDS , Pack Number CDS982909J ;  43) MAG PLASTIC CDS , Pack Number CDS982909K ;  44) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910K ;  45) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910L ;  46) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910M ;  47) MAG FREE FLAP CDS-LF, Pack Number CDS982911K ;  48) GENERAL BREAST, Pack Number CDS983058G ;  49) GENERAL BREAST, Pack Number CDS983058I ;  50) BASIC PLASTIC CDS-LF, Pack Number CDS983141C ;  51) BASIC PLASTIC CDS-LF, Pack Number CDS983141D ;  52) BREAST CDS, Pack Number CDS983148A ;  53) BREAST CDS, Pack Number CDS983148B ;  54) ZALE STEREOTACTIC CDS , Pack Number CDS983173I ;  55) CUH ABDOMINOPLASTY CDS, Pack Number CDS983176I ;  56) MAJOR CDS , Pack Number CDS983292D ;  57) PECTUS REPAIR , Pack Number CDS983353R ;  58) PECTUS REPAIR , Pack Number CDS983353S ;  59) PECTUS REPAIR , Pack Number CDS983353T ;  60) PECTUS REPAIR , Pack Number CDS983353U ;  61) PECTUS REPAIR , Pack Number CDS983353V ;  62) PECTUS REPAIR , Pack Number CDS983353X ;  63) MAMMOPLASTY-LF, Pack Number CDS983478J ;  64) MAMMOPLASTY-LF, Pack Number CDS983478K ;  65) MAMMOPLASTY-LF, Pack Number CDS983478L ;  66) PLASTICS FREE FLAP, Pack Number CDS983493L;  67) PLASTICS FREE FLAP, Pack Number CDS983493M;  68) PLASTIC TORSO-LF, Pack Number CDS983496I ;  69) PLASTIC TORSO-LF, Pack Number CDS983496J ;  70) PLASTIC TORSO-LF, Pack Number CDS983496K ;  71) PLASTIC TORSO-LF, Pack Number CDS983496L ;  72) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498I ;  73) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498J ;  74) ACH PLASTICS BREAST-LF, Pack Number CDS983639C ;  75) ACH PLASTICS BREAST-LF, Pack Number CDS983639D ;  76) ACH PLASTICS BREAST-LF, Pack Number CDS983639G ;  77) ACH PLASTICS BREAST-LF, Pack Number CDS983639I ;  78) ACH PLASTICS BREAST-LF, Pack Number CDS983639J ;  79) ACH PLASTICS BREAST-LF, Pack Number CDS983639K ;  80) NE BREAST AUGMENTATION CDS, Pack Number CDS983660C ;  81) NE BREAST RECON CDS , Pack Number CDS983660D ;  82) NE BREAST RECON (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-3016-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) CHEST EXPLORATION CDS , Pack Number CDS920066K ;  2) CHEST EXPLORATION CDS , Pack Number CDS920066L ;  3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ;  4) PLASTICS, Pack Number CDS980200AA;  5) PLASTICS, Pack Number CDS980200Y ;  6) BREAST/MINOR, Pack Number CDS980228W ;  7) PLASTIC CDS , Pack Number CDS980232U ;  8) PLASTIC CDS , Pack Number CDS980232V ;  9) PLASTIC CDS , Pack Number CDS980232W ;  10) PLASTIC CDS , Pack Number CDS980232X ;  11) LTP CDS-LF, Pack Number CDS980375L ;  12) PLASTIC CDS , Pack Number CDS980457R ;  13) PLASTIC CDS , Pack Number CDS980457S ;  14) PLASTIC CDS , Pack Number CDS980457T ;  15) BREAST AUG, Pack Number CDS980567R ;  16) BREAST AUG, Pack Number CDS980567S ;  17) LARGE PROCEDURE-LF, Pack Number CDS981257J ;  18) LARGE PROCEDURE-LF, Pack Number CDS981257K ;  19) BREAST CDS, Pack Number CDS981691N ;  20) MAJOR PLASTICS CDS, Pack Number CDS981958I ;  21) MAJOR PLASTIC CDS-LF, Pack Number CDS981978J ;  22) MINOR PLASTIC , Pack Number CDS982018K ;  23) MAJOR BREAST, Pack Number CDS982038S ;  24) VASAL RECONSTRUCTION, Pack Number CDS982042O ;  25) MINOR BREAST, Pack Number CDS982053M ;  26) MINOR BREAST, Pack Number CDS982053N ;  27) MINOR BREAST, Pack Number CDS982053O ;  28) MINOR BREAST, Pack Number CDS982053P ;  29) BREAST AUGMENTATION , Pack Number CDS982254K ;  30) BREAST AUGMENTATION , Pack Number CDS982254L ;  31) BREAST AUGMENTATION , Pack Number CDS982254M ;  32) BREAST REDUCTION CDS, Pack Number CDS982255G ;  33) BREAST REDUCTION CDS, Pack Number CDS982255I ;  34) BREAST REDUCTION, Pack Number CDS982255J ;  35) TYMPANOPLASTY , Pack Number CDS982720M ;  36) MAJOR BREAST CDS SJF-LF , Pack Number CDS982730M ;  37) REDUCTION CDS , Pack Number CDS982776J ;  38) REDUCTION CDS , Pack Number CDS982776K ;  39) REDUCTION CDS , Pack Number CDS982776L ;  40) HMT MAJOR BREAST/PLASTICS CDS , Pack Number CDS982860R ;  41) MAG PLASTIC CDS , Pack Number CDS982909I ;  42) MAG PLASTIC CDS , Pack Number CDS982909J ;  43) MAG PLASTIC CDS , Pack Number CDS982909K ;  44) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910K ;  45) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910L ;  46) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910M ;  47) MAG FREE FLAP CDS-LF, Pack Number CDS982911K ;  48) GENERAL BREAST, Pack Number CDS983058G ;  49) GENERAL BREAST, Pack Number CDS983058I ;  50) BASIC PLASTIC CDS-LF, Pack Number CDS983141C ;  51) BASIC PLASTIC CDS-LF, Pack Number CDS983141D ;  52) BREAST CDS, Pack Number CDS983148A ;  53) BREAST CDS, Pack Number CDS983148B ;  54) ZALE STEREOTACTIC CDS , Pack Number CDS983173I ;  55) CUH ABDOMINOPLASTY CDS, Pack Number CDS983176I ;  56) MAJOR CDS , Pack Number CDS983292D ;  57) PECTUS REPAIR , Pack Number CDS983353R ;  58) PECTUS REPAIR , Pack Number CDS983353S ;  59) PECTUS REPAIR , Pack Number CDS983353T ;  60) PECTUS REPAIR , Pack Number CDS983353U ;  61) PECTUS REPAIR , Pack Number CDS983353V ;  62) PECTUS REPAIR , Pack Number CDS983353X ;  63) MAMMOPLASTY-LF, Pack Number CDS983478J ;  64) MAMMOPLASTY-LF, Pack Number CDS983478K ;  65) MAMMOPLASTY-LF, Pack Number CDS983478L ;  66) PLASTICS FREE FLAP, Pack Number CDS983493L;  67) PLASTICS FREE FLAP, Pack Number CDS983493M;  68) PLASTIC TORSO-LF, Pack Number CDS983496I ;  69) PLASTIC TORSO-LF, Pack Number CDS983496J ;  70) PLASTIC TORSO-LF, Pack Number CDS983496K ;  71) PLASTIC TORSO-LF, Pack Number CDS983496L ;  72) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498I ;  73) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498J ;  74) ACH PLASTICS BREAST-LF, Pack Number CDS983639C ;  75) ACH PLASTICS BREAST-LF, Pack Number CDS983639D ;  76) ACH PLASTICS BREAST-LF, Pack Number CDS983639G ;  77) ACH PLASTICS BREAST-LF, Pack Number CDS983639I ;  78) ACH PLASTICS BREAST-LF, Pack Number CDS983639J ;  79) ACH PLASTICS BREAST-LF, Pack Number CDS983639K ;  80) NE BREAST AUGMENTATION CDS, Pack Number CDS983660C ;  81) NE BREAST RECON CDS , Pack Number CDS983660D ;  82) NE BREAST RECON",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3016-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3016-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) CHEST EXPLORATION CDS , Pack Number CDS920066K ;  2) CHEST EXPLORATION CDS , Pack Number CDS920066L ;  3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ;  4) PLASTICS, Pack Number CDS980200AA;  5) PLASTICS, Pack Number CDS980200Y ;  6) BREAST/MINOR, Pack Number CDS980228W ;  7) PLASTIC CDS , Pack Number CDS980232U ;  8) PLASTIC CDS , Pack Number CDS980232V ;  9) PLASTIC CDS , Pack Number CDS980232W ;  10) PLASTIC CDS , Pack Number CDS980232X ;  11) LTP CDS-LF, Pack Number CDS980375L ;  12) PLASTIC CDS , Pack Number CDS980457R ;  13) PLASTIC CDS , Pack Number CDS980457S ;  14) PLASTIC CDS , Pack Number CDS980457T ;  15) BREAST AUG, Pack Number CDS980567R ;  16) BREAST AUG, Pack Number CDS980567S ;  17) LARGE PROCEDURE-LF, Pack Number CDS981257J ;  18) LARGE PROCEDURE-LF, Pack Number CDS981257K ;  19) BREAST CDS, Pack Number CDS981691N ;  20) MAJOR PLASTICS CDS, Pack Number CDS981958I ;  21) MAJOR PLASTIC CDS-LF, Pack Number CDS981978J ;  22) MINOR PLASTIC , Pack Number CDS982018K ;  23) MAJOR BREAST, Pack Number CDS982038S ;  24) VASAL RECONSTRUCTION, Pack Number CDS982042O ;  25) MINOR BREAST, Pack Number CDS982053M ;  26) MINOR BREAST, Pack Number CDS982053N ;  27) MINOR BREAST, Pack Number CDS982053O ;  28) MINOR BREAST, Pack Number CDS982053P ;  29) BREAST AUGMENTATION , Pack Number CDS982254K ;  30) BREAST AUGMENTATION , Pack Number CDS982254L ;  31) BREAST AUGMENTATION , Pack Number CDS982254M ;  32) BREAST REDUCTION CDS, Pack Number CDS982255G ;  33) BREAST REDUCTION CDS, Pack Number CDS982255I ;  34) BREAST REDUCTION, Pack Number CDS982255J ;  35) TYMPANOPLASTY , Pack Number CDS982720M ;  36) MAJOR BREAST CDS SJF-LF , Pack Number CDS982730M ;  37) REDUCTION CDS , Pack Number CDS982776J ;  38) REDUCTION CDS , Pack Number CDS982776K ;  39) REDUCTION CDS , Pack Number CDS982776L ;  40) HMT MAJOR BREAST/PLASTICS CDS , Pack Number CDS982860R ;  41) MAG PLASTIC CDS , Pack Number CDS982909I ;  42) MAG PLASTIC CDS , Pack Number CDS982909J ;  43) MAG PLASTIC CDS , Pack Number CDS982909K ;  44) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910K ;  45) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910L ;  46) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910M ;  47) MAG FREE FLAP CDS-LF, Pack Number CDS982911K ;  48) GENERAL BREAST, Pack Number CDS983058G ;  49) GENERAL BREAST, Pack Number CDS983058I ;  50) BASIC PLASTIC CDS-LF, Pack Number CDS983141C ;  51) BASIC PLASTIC CDS-LF, Pack Number CDS983141D ;  52) BREAST CDS, Pack Number CDS983148A ;  53) BREAST CDS, Pack Number CDS983148B ;  54) ZALE STEREOTACTIC CDS , Pack Number CDS983173I ;  55) CUH ABDOMINOPLASTY CDS, Pack Number CDS983176I ;  56) MAJOR CDS , Pack Number CDS983292D ;  57) PECTUS REPAIR , Pack Number CDS983353R ;  58) PECTUS REPAIR , Pack Number CDS983353S ;  59) PECTUS REPAIR , Pack Number CDS983353T ;  60) PECTUS REPAIR , Pack Number CDS983353U ;  61) PECTUS REPAIR , Pack Number CDS983353V ;  62) PECTUS REPAIR , Pack Number CDS983353X ;  63) MAMMOPLASTY-LF, Pack Number CDS983478J ;  64) MAMMOPLASTY-LF, Pack Number CDS983478K ;  65) MAMMOPLASTY-LF, Pack Number CDS983478L ;  66) PLASTICS FREE FLAP, Pack Number CDS983493L;  67) PLASTICS FREE FLAP, Pack Number CDS983493M;  68) PLASTIC TORSO-LF, Pack Number CDS983496I ;  69) PLASTIC TORSO-LF, Pack Number CDS983496J ;  70) PLASTIC TORSO-LF, Pack Number CDS983496K ;  71) PLASTIC TORSO-LF, Pack Number CDS983496L ;  72) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498I ;  73) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498J ;  74) ACH PLASTICS BREAST-LF, Pack Number CDS983639C ;  75) ACH PLASTICS BREAST-LF, Pack Number CDS983639D ;  76) ACH PLASTICS BREAST-LF, Pack Number CDS983639G ;  77) ACH PLASTICS BREAST-LF, Pack Number CDS983639I ;  78) ACH PLASTICS BREAST-LF, Pack Number CDS983639J ;  79) ACH PLASTICS BREAST-LF, Pack Number CDS983639K ;  80) NE BREAST AUGMENTATION CDS, Pack Number CDS983660C ;  81) NE BREAST RECON CDS , Pack Number CDS983660D ;  82) NE BREAST RECON",
      "text": "The FDA logged enforcement record Z-3016-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) CHEST EXPLORATION CDS , Pack Number CDS920066K ;  2) CHEST EXPLORATION CDS , Pack Number CDS920066L ;  3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ;  4) PLASTICS, Pack Number CDS980200AA;  5) PLASTICS, Pack Number CDS980200Y ;  6) BREAST/MINOR, Pack Number CDS980228W ;  7) PLASTIC CDS , Pack Number CDS980232U ;  8) PLASTIC CDS , Pack Number CDS980232V ;  9) PLASTIC CDS , Pack Number CDS980232W ;  10) PLASTIC CDS , Pack Number CDS980232X ;  11) LTP CDS-LF, Pack Number CDS980375L ;  12) PLASTIC CDS , Pack Number CDS980457R ;  13) PLASTIC CDS , Pack Number CDS980457S ;  14) PLASTIC CDS , Pack Number CDS980457T ;  15) BREAST AUG, Pack Number CDS980567R ;  16) BREAST AUG, Pack Number CDS980567S ;  17) LARGE PROCEDURE-LF, Pack Number CDS981257J ;  18) LARGE PROCEDURE-LF, Pack Number CDS981257K ;  19) BREAST CDS, Pack Number CDS981691N ;  20) MAJOR PLASTICS CDS, Pack Number CDS981958I ;  21) MAJOR PLASTIC CDS-LF, Pack Number CDS981978J ;  22) MINOR PLASTIC , Pack Number CDS982018K ;  23) MAJOR BREAST, Pack Number CDS982038S ;  24) VASAL RECONSTRUCTION, Pack Number CDS982042O ;  25) MINOR BREAST, Pack Number CDS982053M ;  26) MINOR BREAST, Pack Number CDS982053N ;  27) MINOR BREAST, Pack Number CDS982053O ;  28) MINOR BREAST, Pack Number CDS982053P ;  29) BREAST AUGMENTATION , Pack Number CDS982254K ;  30) BREAST AUGMENTATION , Pack Number CDS982254L ;  31) BREAST AUGMENTATION , Pack Number CDS982254M ;  32) BREAST REDUCTION CDS, Pack Number CDS982255G ;  33) BREAST REDUCTION CDS, Pack Number CDS982255I ;  34) BREAST REDUCTION, Pack Number CDS982255J ;  35) TYMPANOPLASTY , Pack Number CDS982720M ;  36) MAJOR BREAST CDS SJF-LF , Pack Number CDS982730M ;  37) REDUCTION CDS , Pack Number CDS982776J ;  38) REDUCTION CDS , Pack Number CDS982776K ;  39) REDUCTION CDS , Pack Number CDS982776L ;  40) HMT MAJOR BREAST/PLASTICS CDS , Pack Number CDS982860R ;  41) MAG PLASTIC CDS , Pack Number CDS982909I ;  42) MAG PLASTIC CDS , Pack Number CDS982909J ;  43) MAG PLASTIC CDS , Pack Number CDS982909K ;  44) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910K ;  45) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910L ;  46) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910M ;  47) MAG FREE FLAP CDS-LF, Pack Number CDS982911K ;  48) GENERAL BREAST, Pack Number CDS983058G ;  49) GENERAL BREAST, Pack Number CDS983058I ;  50) BASIC PLASTIC CDS-LF, Pack Number CDS983141C ;  51) BASIC PLASTIC CDS-LF, Pack Number CDS983141D ;  52) BREAST CDS, Pack Number CDS983148A ;  53) BREAST CDS, Pack Number CDS983148B ;  54) ZALE STEREOTACTIC CDS , Pack Number CDS983173I ;  55) CUH ABDOMINOPLASTY CDS, Pack Number CDS983176I ;  56) MAJOR CDS , Pack Number CDS983292D ;  57) PECTUS REPAIR , Pack Number CDS983353R ;  58) PECTUS REPAIR , Pack Number CDS983353S ;  59) PECTUS REPAIR , Pack Number CDS983353T ;  60) PECTUS REPAIR , Pack Number CDS983353U ;  61) PECTUS REPAIR , Pack Number CDS983353V ;  62) PECTUS REPAIR , Pack Number CDS983353X ;  63) MAMMOPLASTY-LF, Pack Number CDS983478J ;  64) MAMMOPLASTY-LF, Pack Number CDS983478K ;  65) MAMMOPLASTY-LF, Pack Number CDS983478L ;  66) PLASTICS FREE FLAP, Pack Number CDS983493L;  67) PLASTICS FREE FLAP, Pack Number CDS983493M;  68) PLASTIC TORSO-LF, Pack Number CDS983496I ;  69) PLASTIC TORSO-LF, Pack Number CDS983496J ;  70) PLASTIC TORSO-LF, Pack Number CDS983496K ;  71) PLASTIC TORSO-LF, Pack Number CDS983496L ;  72) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498I ;  73) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498J ;  74) ACH PLASTICS BREAST-LF, Pack Number CDS983639C ;  75) ACH PLASTICS BREAST-LF, Pack Number CDS983639D ;  76) ACH PLASTICS BREAST-LF, Pack Number CDS983639G ;  77) ACH PLASTICS BREAST-LF, Pack Number CDS983639I ;  78) ACH PLASTICS BREAST-LF, Pack Number CDS983639J ;  79) ACH PLASTICS BREAST-LF, Pack Number CDS983639K ;  80) NE BREAST AUGMENTATION CDS, Pack Number CDS983660C ;  81) NE BREAST RECON CDS , Pack Number CDS983660D ;  82) NE BREAST RECON — 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: CDS920066K , Lot Number 19ABM835 ;  CDS920066K , Lot Number 19CBD966 ;  CDS920066K , Lot Number 19DBS028 ;  CDS920066L , Lot Number 19FBR839 ;  CDS920066L , Lot Number 20DBM938 ;  CDS920066L , Lot Number 20GBG553 ;  CDS920066L , Lot Number 20IBF930 ;  CDS920066L , Lot Number 20IBL798 ;  CDS980088K , Lot Number 19ABF841 ;  CDS980088K , Lot Number 19BBR779 ;  CDS980088K , Lot Number 19CBI036 ;  CDS980088K , Lot Number 19EBY389 ;  CDS980088K , Lot Number 19HBO214 ;  CDS980088K , Lot Number 19HBU649 ;  CDS980088K , Lot Number 19IBX782 ;  CDS980200AA, Lot Number 21HBO940 ;  CDS980200AA, Lot Number 21KBH187 ;  CDS980200AA, Lot Number 22ABI736 ;  CDS980200AA, Lot Number 22EBS477 ;  CDS980200AA, Lot Number 22FBE877 ;  CDS980200AA, Lot Number 22FBG077 ;  CDS980200AA, Lot Number 22GBA222 ;  CDS980200AA, Lot Number 22HBL578 ;  CDS980200AA, Lot Number 22HBN078 ;  CDS980200AA, Lot Number 22IBD419 ;  CDS980200AA, Lot Number 22JBQ932 ;  CDS980200AA, Lot Number 22KBJ570 ;  CDS980200AA, Lot Number 22KBM262 ;  CDS980200AA, Lot Number 23ABN721 ;  CDS980200AA, Lot Number 23CBD776 ;  CDS980200AA, Lot Number 23EBD623 ;  CDS980200AA, Lot Number 23EBK657 ;  CDS980200AA, Lot Number 23HBK655 ;  CDS980200AA, Lot Number 23IBU758 ;  CDS980200AA, Lot Number 23JBJ092 ;  CDS980200AA, Lot Number 23KBA249 ;  CDS980200AA, Lot Number 24ABV345 ;  CDS980200AA, Lot Number 21CBF899 ;  CDS980200AA, Lot Number 21EBO710 ;  CDS980200Y , Lot Number 19ABR558 ;  CDS980200Y , Lot Number 19DBG664 ;  CDS980200Y , Lot Number 19FBZ748 ;  CDS980200Y , Lot Number 19HBB367 ;  CDS980200Y , Lot Number 19TBB908 ;  CDS980200Y , Lot Number 19JBC014 ;  CDS980200Y , Lot Number 19KBN743 ;  CDS980200Y , Lot Number 20BBE167 ;  CDS980200Y , Lot Number 20DBH152 ;  CDS980200Y , Lot Number 20FBR880 ;  CDS980200Y , Lot Number 20HBE774 ;  CDS980200Y , Lot Number 20IBG766 ;  CDS980200Y , Lot Number 20JBR282 ;  CDS980200Y , Lot Number 20LBQ487 ;  CDS980200Y , Lot Number 21ABC248 ;  CDS980228W , Lot Number 19ABW907 ;  CDS980228W , Lot Number 19BBL561 ;  CDS980228W , Lot Number 19CBM174 ;  CDS980228W , Lot Number 19EBN810 ;  CDS980228W , Lot Number 19FBN128 ;  CDS980228W , Lot Number 19HBH107 ;  CDS980228W , Lot Number 19HBX070 ;  CDS980228W , Lot Number 19JBA329 ;  CDS980228W , Lot Number 19KBH852 ;  CDS980228W , Lot Number 19LBR795 ;  CDS980228W , Lot Number 20BBQ462 ;  CDS980228W , Lot Number 20BBZ179 ;  CDS980228W , Lot Number 20EBI895 ;  CDS980228W , Lot Number 20FBK517 ;  CDS980228W , Lot Number 20GBR042 ;  CDS980228W , Lot Number 20IBI018 ;  CDS980228W , Lot Number 20JBR049 ;  CDS980228W , Lot Number 20KBT175 ;  CDS980228W , Lot Number 21ABC714 ;  CDS980228W , Lot Number 21BBG051 ;  CDS980228W , Lot Number 21CBU644 ;  CDS980228W , Lot Number 21EBH357 ;  CDS980232U , Lot Number 19BBH968 ;  CDS980232U , Lot Number 19CBK976 ;  CDS980232U , Lot Number 19EBU029 ;  CDS980232U , Lot Number 19FBS139 ;  CDS980232U , Lot Number 19GBW172 ;  CDS980232U , Lot Number 19HBM330 ;  CDS980232U , Lot Number 19VBF307 ;  CDS980232U , Lot Number 19LBK396 ;  CDS980232V , Lot Number 19KBR773 ;  CDS980232V , Lot Number 20ABF339 ;  CDS980232V , Lot Number 20BBB986 ;  CDS980232V , Lot Number 20BBU668 ;  CDS980232V , Lot Number 20CBR984 ;  CDS980232V , Lot Number 20CBW496 ;  CDS980232V , Lot Number 20DBL307 ;  CDS980232V , Lot Number 20EBO737 ;  CDS980232V , Lot Number 20FBF081 ;  CDS980232V , Lot Number 20GBB769 ;  CDS980232V , Lot Number 20HBE599 ;  CDS980232V , Lot Number 20IBF392 ;  CDS980232V , Lot Number 20IBR161 ;  CDS980232V , Lot Number 20KBB632 ;  CDS980232V , Lot Number 20LBS158 ;  CDS980232V , Lot Number 21BBD337 ;  CDS980232V , Lot Number 21BBF806 ;  CDS980232V , Lot Number 21CBT360 ;  CDS980232V , Lot Number 21DBC544 ;  CDS980232V , Lot Number 21EBI364 ;  CDS980232W , Lot Number 21IBL710 ;  CDS980232W , Lot Number 21IBP897 ;  CDS980232W , Lot Number 21IBP933 ;  CDS980232W , Lot Number 22CBT696 ;  CDS980232W , Lot Number 22DBM998 ;  CDS980232W , Lot Number 22EBA374 ;  CDS980232W , Lot Number 22FBM675 ;  CDS980232W , Lot Number 22FBQ776 ;  CDS980232W , Lot Number 22GBJ142 ;  CDS980232W , Lot Number 22IBC631 ;  CDS980232W , Lot Number 22JBH353 ;  CDS980232W , Lot Number 22KBI842 ;  CDS980232W , Lot Number 23ABC334 ;  CDS980232W , Lot Number 23ABR031 ;  CDS980232W , Lot Number 23CBQ219 ;  CDS980232W , Lot Number 23EBE138 ;  CDS980232W , Lot Number 23EBR956 ;  CDS980232W , Lot Number 23FBL917 ;  CDS980232W , Lot Number 23HBH389 ;  CDS980232W , Lot Number 23HBS954 ;  CDS980232X , Lot Number 24ABB890 ;  CDS980232X , Lot Number 24ABC730 ;  CDS980232X , Lot Number 24ABP304 ;  CDS980375L , Lot Number 21HBG608 ;  CDS980375L , Lot Number 21IBT137 ;  CDS980375L , Lot Number 22CBX667 ;  CDS980375L , Lot Number 22DBS948 ;  CDS980375L , Lot Number 22FBX069 ;  CDS980375L , Lot Number 22IBF741 ;  CDS980375L , Lot Number 22KBC504 ;  CDS980375L , Lot Number 22LBI985 ;  CDS980375L , Lot Number 23DBF906 ;  CDS980375L , Lot Number 23GBD593 ;  CDS980375L , Lot Number 23GBD781 ;  CDS980375L , Lot Number 23KBN711 ;  CDS980375L , Lot Number 23KBW165 ;  CDS980457R , Lot Number 19ABN815 ;  CDS980457R , Lot Number 19EBU647 ;  CDS980457R , Lot Number 19HBE668 ;  CDS980457R , Lot Number 19IBF973 ;  CDS980457R , Lot Number 19LBI230 ;  CDS980457R , Lot Number 20BBA372 ;  CDS980457R , Lot Number 20DBQ371 ;  CDS980457R , Lot Number 20GBJ958 ;  CDS980457S , Lot Number 21LBD714 ;  CDS980457S , Lot Number 22BBZ405 ;  CDS980457S , Lot Number 22EMG704 ;  CDS980457S , Lot Number 22HMH882 ;  CDS980457S , Lot Number 23AME148 ;  CDS980457S , Lot Number 23BMB462 ;  CDS980457S , Lot Number 23DMH737 ;  CDS980457T , Lot Number 23GMA948 ;  CDS980457T , Lot Number 23GMF038 ;  CDS980567R , Lot Number 19CBB293 ;  CDS980567R , Lot Number 19DBZ728 ;  CDS980567R , Lot Number 19FBG689 ;  CDS980567S , Lot Number 19FBG716 ;  CDS980567S , Lot Number 19HBK399 ;  CDS980567S , Lot Number 19IBT497 ;  CDS980567S , Lot Number 20BBC189 ;  CDS981257J , Lot Number 21FBN638 ;  CDS981257J , Lot Number 21FBR091 ;  CDS981257J , Lot Number 19CBD409 ;  CDS981257J , Lot Number 19DBL599 ;  CDS981257J , Lot Number 19EBD716 ;  CDS981257J , Lot Number 19FBQ266 ;  CDS981257J , Lot Number 19GBL111 ;  CDS981257J , Lot Number 19HBA947 ;  CDS981257J , Lot Number 19IBQ134 ;  CDS981257J , Lot Number 19KBP671 ;  CDS981257J , Lot Number 19KBQ866 ;  CDS981257J , Lot Number 20CBD269 ;  CDS981257J , Lot Number 20EBA007 ;  CDS981257J , Lot Number 20EBC274 ;  CDS981257J , Lot Number 20GBH203 ;  CDS981257J , Lot Number 20HBI869 ;  CDS981257J , Lot Number 20HBV936 ;  CDS981257J , Lot Number 20IBF406 ;  CDS981257J , Lot Number 20IBS593 ;  CDS981257J , Lot Number 20JBN637 ;  CDS981257J , Lot Number 21CBB696 ;  CDS981257J , Lot Number 21DBF086 ;  CDS981257J , Lot Number 21EBC573 ;  CDS981257J , Lot Number 21EBG508 ;  CDS981257J , Lot Number 21GMC225 ;  CDS981257K , Lot Number 21KME233 ;  CDS981257K , Lot Number 21KMH490 ;  CDS981257K , Lot Number 21LMD144 ;  CDS981257K , Lot Number 22AMD021 ;  CDS981257K , Lot Number 22AMD022 ;  CDS981257K , Lot Number 22AMG535 ;  CDS981257K , Lot Number 22DME520 ;  CDS981257K , Lot Number 22GMA213 ;  CDS981257K , Lot Number 22GMF576 ;  CDS981257K , Lot Number 22JMA037 ;  CDS981257K , Lot Number 22KMD512 ;  CDS981257K , Lot Number 22LMD006 ;  CDS981257K , Lot Number 23AMB195 ;  CDS981257K , Lot Number 23AMF452 ;  CDS981257K , Lot Number 23AMG701 ;  CDS981257K , Lot Number 23DMI539 ;  CDS981257K , Lot Number 23EMD596 ;  CDS981257K , Lot Number 23EMG510 ;  CDS981257K , Lot Number 23EMI980 ;  CDS981257K , Lot Number 23GMC869 ;  CDS981257K , Lot Number 23GMI568 ;  CDS981257K , Lot Number 23IMC179 ;  CDS981257K , Lot Number 23JMB398 ;  CDS981257K , Lot Number 23KMC027 ;  CDS981257K , Lot Number 23KMH664 ;  CDS981257K , Lot Number 23LMH862 ;  CDS981257K , Lot Number 24AMH806 ;  CDS981691N , Lot Number 21EME333 ;  CDS981691N , Lot Number 21GME796 ;  CDS981691N , Lot Number 21JMB026 ;  CDS981691N , Lot Number 21JMI360 ;  CDS981691N , Lot Number 21LMG394 ;  CDS981691N , Lot Number 22AME297 ;  CDS981691N , Lot Number 22CMC509 ;  CDS981691N , Lot Number 22FMF879 ;  CDS981691N , Lot Number 22IMA979 ;  CDS981691N , Lot Number 22IMC189 ;  CDS981691N , Lot Number 22IMD080 ;  CDS981691N , Lot Number 22JMA039 ;  CDS981691N , Lot Number 22JME639 ;  CDS981691N , Lot Number 23CMG688 ;  CDS981691N , Lot Number 23DME083 ;  CDS981691N , Lot Number 19AKB352 ;  CDS981691N , Lot Number 19BKA421 ;  CDS981691N , Lot Number 19BKD063 ;  CDS981691N , Lot Number 19CKC346 ;  CDS981691N , Lot Number 19DKB150 ;  CDS981691N , Lot Number 19EKD156 ;  CDS981691N , Lot Number 19FKB545 ;  CDS981691N , Lot Number 19GKB205 ;  CDS981691N , Lot Number 19HKA748 ;  CDS981691N , Lot Number 19HKC704 ;  CDS981691N , Lot Number 19JKA921 ;  CDS981691N , Lot Number 19LKB015 ;  CDS981691N , Lot Number 20CKA733 ;  CDS981691N , Lot Number 20EKB934 ;  CDS981691N , Lot Number 20IKB130 ;  CDS981691N , Lot Number 20KKA685 ;  CDS981691N , Lot Number 21AKA403 ;  CDS981691N , Lot Number 21BKA460 ;  CDS981691N , Lot Number 21DKA185 ;  CDS981958I , Lot Number 19CBM315 ;  CDS981958I , Lot Number 19EBZ741 ;  CDS981958I , Lot Number 19HBH832 ;  CDS981958I , Lot Number 19IBE324 ;  CDS981958I , Lot Number 19VBE088 ;  CDS981958I , Lot Number 20FBC068 ;  CDS981958I , Lot Number 20FBS317 ;  CDS981958I , Lot Number 20GBP254 ;  CDS981958I , Lot Number 20HBG317 ;  CDS981958I , Lot Number 20IBC427 ;  CDS981958I , Lot Number 20IBD365 ;  CDS981978J , Lot Number 22ABS129 ;  CDS981978J , Lot Number 22BBW393 ;  CDS981978J , Lot Number 22OBM375 ;  CDS981978J , Lot Number 22DBE792 ;  CDS981978J , Lot Number 22FBT440 ;  CDS981978J , Lot Number 22GBP083 ;  CDS981978J , Lot Number 22HBS542 ;  CDS981978J , Lot Number 19HBE289 ;  CDS981978J , Lot Number 19HBN029 ;  CDS981978J , Lot Number 22KBS125 ;  CDS981978J , Lot Number 23BBG739 ;  CDS981978J , Lot Number 19KBZ001 ;  CDS981978J , Lot Number 19LBU222 ;  CDS981978J , Lot Number 23EBM504 ;  CDS981978J , Lot Number 20BBQ333 ;  CDS981978J , Lot Number 23HBD015 ;  CDS981978J , Lot Number 23IBI896 ;  CDS981978J , Lot Number 20EBV123 ;  CDS981978J , Lot Number 23JBT303 ;  CDS981978J , Lot Number 23KBJ612 ;  CDS981978J , Lot Number 24ABB202 ;  CDS981978J , Lot Number 20KBF396 ;  CDS981978J , Lot Number 20KBG259 ;  CDS981978J , Lot Number 20LBT139 ;  CDS981978J , Lot Number 21DBI647 ;  CDS981978J , Lot Number 21DBT956 ;  CDS981978J , Lot Number 21EBH609 ;  CDS982018K , Lot Number 21GBP350 ;  CDS982018K , Lot Number 21IBP808 ;  CDS982018K , Lot Number 21JBN498 ;  CDS982018K , Lot Number 21DBA517 ;  CDS982018K , Lot Number 21DBJ935 ;  CDS982038S , Lot Number 19IDC120 ;  CDS982038S , Lot Number 19IDC919 ;  CDS982038S , Lot Number 19JDC530 ;  CDS982038S , Lot Number 20BDA460 ;  CDS982038S , Lot Number 20DDB470 ;  CDS982038S , Lot Number 20EDB148 ;  CDS982038S , Lot Number 20EDC015 ;  CDS982042O , Lot Number 21KBZ606 ;  CDS982042O , Lot Number 21KBZ607 ;  CDS982042O , Lot Number 22GBL942 ;  CDS982042O , Lot Number 22GBU465 ;  CDS982042O , Lot Number 22IBA637 ;  CDS982042O , Lot Number 22IBB277 ;  CDS982053M , Lot Number 19CDA667 ;  CDS982053M , Lot Number 19EDB236 ; 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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
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      "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-3016-2024&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-3016-2024&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-3016-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3016-2024 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": {
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        "adjudged": true,
        "operative": true
      },
      "grounding": {
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        "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-3016-2024&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-3016-2024&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-3016-2024/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",
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        "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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        {
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          "item": {
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            "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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 CDS983292D , Lot Number 22IBJ977 ;  CDS983292D , Lot Number 19HBD978 ;  CDS983292D , Lot Number 19HBU784 ;  CDS983292D , Lot Number 19JBK972 ;  CDS983292D , Lot Number 20BBE193 ;  CDS983292D , Lot Number 20CBY292 ;  CDS983292D , Lot Number 20EBK753 ;  CDS983292D , Lot Number 20GBQ822 ;  CDS983292D , Lot Number 20JBP972 ;  CDS983292D , Lot Number 21BBN255 ;  CDS983292D , Lot Number 21EBI524 ;  CDS983353R , Lot Number 19HBD964 ;  CDS983353R , Lot Number 19TBC180 ;  CDS983353R , Lot Number 19IBQ353 ;  CDS983353R , Lot Number 19VBE331 ;  CDS983353S , Lot Number 20DBL312 ;  CDS983353T , Lot Number 20EBT006 ;  CDS983353T , Lot Number 20FBL413 ;  CDS983353T , Lot Number 20GBK672 ;  CDS983353T , Lot Number 20HBJ691 ;  CDS983353T , Lot Number 20WBE715 ;  CDS983353T , Lot Number 20LBV003 ;  CDS983353T , Lot Number 21DBI641 ;  CDS983353U , Lot Number 21GBH401 ;  CDS983353U , Lot Number 21IBC910 ;  CDS983353U , Lot Number 21IBM911 ;  CDS983353U , Lot Number 22ABS123 ;  CDS983353U , Lot Number 22FBF367 ;  CDS983353U , Lot Number 22GBL957 ;  CDS983353V , Lot Number 23BBQ236 ;  CDS983353V , Lot Number 23CBE898 ;  CDS983353V , Lot Number 23CBF299 ;  CDS983353V , Lot Number 23CBT360 ;  CDS983353X , Lot Number 23IBT100 ;  CDS983478J , Lot Number 23EDB718 ;  CDS983478J , Lot Number 23FDA455 ;  CDS983478K , Lot Number 23GDB718 ;  CDS983478L , Lot Number 23JDA999 ;  CDS983478L , Lot Number 23KDB756 ;  CDS983478L , Lot Number 24ADA957 ;  CDS983493L, Lot Number 23IDA434;  CDS983493L, Lot Number 23HDB332;  CDS983493L, Lot Number 23GDA495;  CDS983493L, Lot Number 23FDB617;  CDS983493L, Lot Number 23EDB945;  CDS983493L, Lot Number 22JDA727;  CDS983493L, Lot Number 22FDB173;  CDS983493L, Lot Number 21JDB599;  CDS983493L, Lot Number 21JDB403;  CDS983493L, Lot Number 21IDC321;  CDS983493L, Lot Number 21IDB329;  CDS983493L, Lot Number 21HDA478;  CDS983493L, Lot Number 21GDC463;  CDS983493L, Lot Number 21FDA896;  CDS983493L, Lot Number 21EDB291;  CDS983493L, Lot Number 21CDC134;  CDS983493L, Lot Number 21CDB258;  CDS983493L, Lot Number 20JDC418;  CDS983493L, Lot Number 20JDA421;  CDS983493L, Lot Number 20JDA349;  CDS983493L, Lot Number 20GDB402;  CDS983493L, Lot Number 20GDA317;  CDS983493L, Lot Number 20CDB450;  CDS983493M, Lot Number 24ADA328;  CDS983493M, Lot Number 23LDA144;  CDS983496I , Lot Number 20DDA494 ;  CDS983496I , Lot Number 20FDC128 ;  CDS983496I , Lot Number 20HDA119 ;  CDS983496I , Lot Number 20IDA709 ;  CDS983496I , Lot Number 20IDA993 ;  CDS983496I , Lot Number 20JDA759 ;  CDS983496I , Lot Number 20JDC024 ;  CDS983496J , Lot Number 21FDB637 ;  CDS983496J , Lot Number 21GDB162 ;  CDS983496J , Lot Number 21IDC330 ;  CDS983496J , Lot Number 22GDB064 ;  CDS983496J , Lot Number 22HDB595 ;  CDS983496J , Lot Number 22JDB255 ;  CDS983496J , Lot Number 22KDC128 ;  CDS983496J , Lot Number 23CDB578 ;  CDS983496J , Lot Number 23DDA472 ;  CDS983496J , Lot Number 23EDA835 ;  CDS983496J , Lot Number 23GDA574 ;  CDS983496K , Lot Number 23HDC591 ;  CDS983496K , Lot Number 23IDA291 ;  CDS983496K , Lot Number 23JDA887 ;  CDS983496L , Lot Number 23KDC085 ;  CDS983496L , Lot Number 24ADB601 ;  CDS983498I , Lot Number 19CDA762 ;  CDS983498I , Lot Number 19EDC772 ;  CDS983498I , Lot Number 19GDB541 ;  CDS983498I , Lot Number 19JDA395 ;  CDS983498I , Lot Number 20ADB379 ;  CDS983498J , Lot Number 20DDB463 ;  CDS983498J , Lot Number 20FDB916 ;  CDS983498J , Lot Number 20IDA874 ;  CDS983498J , Lot Number 20KDC606 ;  CDS983498J , Lot Number 21BDB490 ;  CDS983639C , Lot Number 19ABT485 ;  CDS983639C , Lot Number 19CBT693 ;  CDS983639C , Lot Number 19FBK478 ;  CDS983639C , Lot Number 19FBW779 ;  CDS983639C , Lot Number 19HBT472 ;  CDS983639C , Lot Number 19IBH576 ;  CDS983639C , Lot Number 19JBH119 ;  CDS983639C , Lot Number 19KBM293 ;  CDS983639C , Lot Number 20ABN342 ;  CDS983639C , Lot Number 20CBY387 ;  CDS983639D , Lot Number 20EBI629 ;  CDS983639D , Lot Number 20FBR055 ;  CDS983639G , Lot Number 20JBF069 ;  CDS983639G , Lot Number 20LBF165 ;  CDS983639G , Lot Number 21ABO331 ;  CDS983639I , Lot Number 21GBS671 ;  CDS983639I , Lot Number 21VBA239 ;  CDS983639I , Lot Number 22BBY281 ;  CDS983639I , Lot Number 22DBM042 ;  CDS983639I , Lot Number 22EBE644 ;  CDS983639I , Lot Number 22FBP775 ;  CDS983639I , Lot Number 21DBA540 ;  CDS983639I , Lot Number 21DBQ406 ;  CDS983639I , Lot Number 21EBK787 ;  CDS983639J , Lot Number 22IBF004 ;  CDS983639J , Lot Number 22IBF012 ;  CDS983639J , Lot Number 22KBK687 ;  CDS983639J , Lot Number 22LBE960 ;  CDS983639K , Lot Number 23CBV828 ;  CDS983639K , Lot Number 23EBA182 ;  CDS983639K , Lot Number 23EBN996 ;  CDS983639K , Lot Number 23FBH151 ;  CDS983639K , Lot Number 23FBP157 ;  CDS983639K , Lot Number 23GBM569 ;  CDS983660C , Lot Number 19DDC061 ;  CDS983660C , Lot Number 19HDA720 ;  CDS983660C , Lot Number 19JDA745 ;  CDS983660C , Lot Number 19JDC355 ;  CDS983660C , Lot Number 19LDA802 ;  CDS983660D , Lot Number 20BDB913 ;  CDS983660D , Lot Number 20EDA669 ;  CDS983660D , Lot Number 20JDD397 ;  CDS983660D , Lot Number 21ADB687 ;  CDS983660F , Lot Number 21CDC547 ;  CDS983660G , Lot Number 22HBA388 ;  CDS983660G , Lot Number 22HBQ513 ;  CDS983660G , Lot Number 22HBS541 ;  CDS983660G , Lot Number 22IBR079 ;  CDS983660G , Lot Number 22LBO866 ;  CDS983660G , Lot Number 23BBN799 ;  CDS983660G , Lot Number 23EBJ318 ;  CDS983660G , Lot Number 23GBG715 ;  CDS983660G , Lot Number 24ABG785 ;  CDS983660G , Lot Number 24ABT070 ;  CDS983660G , Lot Number 24BBO561 ;  CDS983660G , Lot Number 21HDA472 ;  CDS983660G , Lot Number 21IDB899 ;  CDS983720I , Lot Number 19ABV456 ;  CDS983720I , Lot Number 19CBS628 ;  CDS983720I , Lot Number 19FBK088 ;  CDS983720I , Lot Number 19HBA157 ;  CDS983720J , Lot Number 21FBN797 ;  CDS983720J , Lot Number 21HBP953 ;  CDS983720J , Lot Number 21KBV832 ;  CDS983720J , Lot Number 22BBP016 ;  CDS983720J , Lot Number 22BBP017 ;  CDS983720J , Lot Number 22BBW509 ;  CDS983720J , Lot Number 22EBU136 ;  CDS983720J , Lot Number 22HBC069 ;  CDS983720J , Lot Number 19TBB891 ;  CDS983720J , Lot Number 22KBT157 ;  CDS983720J , Lot Number 22KBT993 ;  CDS983720J , Lot Number 19VBG327 ;  CDS983720J , Lot Number 23BBA893 ;  CDS983720J , Lot Number 23BBB026 ;  CDS983720J , Lot Number 23CBN905 ;  CDS983720J , Lot Number 23EBG032 ;  CDS983720J , Lot Number 20BBH287 ;  CDS983720J , Lot Number 23FBB356 ;  CDS983720J , Lot Number 20BBZ103 ;  CDS983720J , Lot Number 23GBA948 ;  CDS983720J , Lot Number 23GBN730 ;  CDS983720J , Lot Number 20EBF652 ;  CDS983720J , Lot Number 23IBD346 ;  CDS983720J , Lot Number 23JBF538 ;  CDS983720J , Lot Number 20GBB718 ;  CDS983720J , Lot Number 23KBF595 ;  CDS983720J , Lot Number 23LBV017 ;  CDS983720J , Lot Number 20IBL286 ;  CDS983720J , Lot Number 20IBR104 ;  CDS983720J , Lot Number 20JBI715 ;  CDS983720J , Lot Number 20JBU133 ;  CDS983720J , Lot Number 21BBI306 ;  CDS983787C , Lot Number 21EMA513 ;  CDS983787C , Lot Number 21GMB655 ;  CDS983787C , Lot Number 21IMB723 ;  CDS983787C , Lot Number 21IMG023 ;  CDS983787C , Lot Number 21JME460 ;  CDS983787C , Lot Number 22AME252 ;  CDS983787C , Lot Number 22DMC312 ;  CDS983787C , Lot Number 22FMG586 ;  CDS983787C , Lot Number 22GMC280 ;  CDS983787C , Lot Number 22HMC723 ;  CDS983787C , Lot Number 22LME799 ;  CDS983787C , Lot Number 23DMI157 ;  CDS983787C , Lot Number 23EMH183 ;  CDS983787C , Lot Number 23GMD406 ;  CDS983787C , Lot Number 23HMB792 ;  CDS983787C , Lot Number 23JMJ197 ;  CDS983787C , Lot Number 24AMG008 ;  CDS983787C , Lot Number 19BKB623 ;  CDS983787C , Lot Number 19EKA120 ;  CDS983787C , Lot Number 19FKA608 ;  CDS983787C , Lot Number 19GKA276 ;  CDS983787C , Lot Number 19HKC574 ;  CDS983787C , Lot Number 20AKA356 ;  CDS983787C , Lot Number 20AKB597 ;  CDS983787C , Lot Number 20CKA676 ;  CDS983787C , Lot Number 20EKA289 ;  CDS983787C , Lot Number 20GKA529 ;  CDS983787C , Lot Number 20HKA858 ;  CDS983787C , Lot Number 20IKA629 ;  CDS983787C , Lot Number 20JKB057 ;  CDS983787C , Lot Number 20KKB439 ;  CDS983787C , Lot Number 21CKA662 ;  CDS983880D , Lot Number 23IBA324 ;  CDS983880D , Lot Number 23IBG227 ;  CDS983880D , Lot Number 23JBF723 ;  CDS983880D , Lot Number 23JBL892 ;  CDS983880D , Lot Number 23JBT843 ;  CDS983880D , Lot Number 23KBD268 ;  CDS983880D , Lot Number 23KBP677 ;  CDS983880D , Lot Number 23LBM395 ;  CDS983880D , Lot Number 23LBO232 ;  CDS983880D , Lot Number 24ABW361 ;  CDS983996B , Lot Number 19BBH113 ;  CDS983996B , Lot Number 19CBA985 ;  CDS983996B , Lot Number 22GBK836 ;  CDS983996B , Lot Number 22JBM476 ;  CDS983996B , Lot Number 19IBJ434 ;  CDS983996B , Lot Number 19JBS461 ;  CDS983996B , Lot Number 23ABG006 ;  CDS983996B , Lot Number 20BBU847 ;  CDS983996B , Lot Number 23HBG686 ;  CDS983996B , Lot Number 23IBH029 ;  CDS983996B , Lot Number 20GBD829 ;  CDS983996B , Lot Number 20HBD634 ;  CDS983996B , Lot Number 20HBQ701 ;  CDS983996B , Lot Number 20IBF819 ;  CDS983996B , Lot Number 20JBB851 ;  CDS983996B , Lot Number 20KBQ351 ;  CDS983996B , Lot Number 20WBC030 ;  CDS983997B , Lot Number 19BBN590 ;  CDS983997B , Lot Number 19CBA986 ;  CDS983997B , Lot Number 19GBP136 ;  CDS983997B , Lot Number 19JBA352 ;  CDS983997B , Lot Number 19VBE343 ;  CDS983997B , Lot Number 23ABU303 ;  CDS983997B , Lot Number 23BBD093 ;  CDS983997B , Lot Number 23CBO728 ;  CDS983997B , Lot Number 20DBH030 ;  CDS983997B , Lot Number 23HBM158 ;  CDS983997B , Lot Number 20JBH080 ;  CDS983997B , Lot Number 20KBA328 ;  CDS983999B , Lot Number 21JBF862 ;",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}