{
  "@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-3006-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ;  2) LAVH CDS, Pack Number CDS760049AC;  3) LAPAROSCOPY CDS , Pack Number CDS760051AB;  4) LAPAROSCOPY CDS , Pack Number CDS760051AC;  5) LAPAROSCOPY CDS , Pack Number CDS760051AD;  6) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057G ;  7) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057I ;  8) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057J ;  9) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057K ;  10) CYSTO PROCEDURE , Pack Number CDS760062P ;  11) CYSTO PROCEDURE , Pack Number CDS760062Q ;  12) LAPAROSCOPY CDS , Pack Number CDS830216F ;  13) FETAL SURGERY CDS-LF, Pack Number CDS840214Q ;  14) MINOR LAPAROTOMY CDS, Pack Number CDS860016P ;  15) MINOR LAPAROTOMY CDS, Pack Number CDS860016Q ;  16) MINOR LAPAROTOMY CDS, Pack Number CDS860016R ;  17) MINOR LAPAROTOMY CDS, Pack Number CDS860016S ;  18) THOROCOTOMY , Pack Number CDS860040I ;  19) LAPAROTOMY CDS #31-RF , Pack Number CDS860062Q ;  20) LAPAROTOMY CDS #31-RF , Pack Number CDS860062R ;  21) LAPAROTOMY CDS #31-RF , Pack Number CDS860062S ;  22) GYN LAP , Pack Number CDS860087K ;  23) GYN LAP , Pack Number CDS860087M ;  24) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107P ;  25) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107Q ;  26) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107R ;  27) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107S ;  28) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108K ;  29) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108L ;  30) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108M ;  31) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108N ;  32) LAP GASTRIC BYPASS CDS, Pack Number CDS860146J ;  33) LAP GASTRIC BYPASS CDS, Pack Number CDS860146K ;  34) LAP GASTRIC BYPASS CDS, Pack Number CDS860146L ;  35) LAP GASTRIC BYPASS CDS, Pack Number CDS860146M ;  36) ABDOMINAL ANEURYSM PROCEDURE, Pack Number CDS860181D ;  37) LAPAROSCOPY CDS , Pack Number CDS860194F ;  38) LAPAROSCOPY CDS , Pack Number CDS860194G ;  39) LAPAROSCOPY CDS , Pack Number CDS860194I ;  40) LAPAROSCOPY CDS , Pack Number CDS860229G ;  41) LAPAROSCOPY CDS-LF, Pack Number CDS860235G ;  42) LAPAROSCOPY CDS-LF, Pack Number CDS860235I ;  43) LAPAROSCOPY CDS-LF, Pack Number CDS860235J ;  44) BARI GASTRECTOMY CDS, Pack Number CDS860237AA;  45) BARI GASTRECTOMY CDS, Pack Number CDS860237AB;  46) BARI GASTRECTOMY CDS, Pack Number CDS860237AC;  47) BARI GASTRECTOMY CDS, Pack Number CDS860237X ;  48) BARI GASTRECTOMY CDS, Pack Number CDS860237Y ;  49) CYSTO , Pack Number CDS902753F ;  50) LAPAROSCOPIC CDS, Pack Number CDS920043T ;  51) BASIC LAPAROSCOPY CDS , Pack Number CDS920080P ;  52) BASIC LAPAROSCOPY CDS , Pack Number CDS920080Q ;  53) BASIC LAPAROSCOPY CDS , Pack Number CDS920080R ;  54) BASIC LAPAROSCOPY CDS , Pack Number CDS920080S ;  55) BASIC LAPAROSCOPY CDS , Pack Number CDS920080T ;  56) LAPAROSCOPIC, Pack Number CDS920082X ;  57) LAPAROSCOPIC, Pack Number CDS920082Y ;  58) LAPAROSCOPY CDS-LF, Pack Number CDS920104F ;  59) LAPAROSCOPY CDS-LF, Pack Number CDS920104G ;  60) LAPAROSCOPY CDS-LF, Pack Number CDS920104I ;  61) LAPAROSCOPY CDS-LF, Pack Number CDS920126AC;  62) GENERAL LAPAROSCOPY , Pack Number CDS930027T ;  63) GENERAL LAPAROSCOPY , Pack Number CDS930027U ;  64) GENERAL LAPAROSCOPY , Pack Number CDS930027V ;  65) LAP CHOLE CDS-LF, Pack Number CDS930030T ;  66) LAP CHOLE CDS-LF, Pack Number CDS930030U ;  67) LAP CHOLE , Pack Number CDS930089AA;  68) LAP CHOLE CDS , Pack Number CDS930111AA;  69) LAP CHOLE CDS , Pack Number CDS930111AB;  70) LAP CHOLE CDS-LF, Pack Number CDS930117J ;  71) MINOR BASIC-LF, Pack Number CDS930120G ;  72) MINOR BASIC-LF, Pack Number CDS930120I ;  73) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125R ;  74) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125S ;  75) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125T ;  76) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125U ;  77) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125V ;  78)",
  "description": "FDA recall Z-3006-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ;  2) LAVH CDS, Pack Number CDS760049AC;  3) LAPAROSCOPY CDS , Pack Number CDS760051AB;  4) LAPAROSCOPY CDS , Pack Number CDS760051AC;  5) LAPAROSCOPY CDS , Pack Number CDS760051AD;  6) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057G ;  7) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057I ;  8) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057J ;  9) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057K ;  10) CYSTO PROCEDURE , Pack Number CDS760062P ;  11) CYSTO PROCEDURE , Pack Number CDS760062Q ;  12) LAPAROSCOPY CDS , Pack Number CDS830216F ;  13) FETAL SURGERY CDS-LF, Pack Number CDS840214Q ;  14) MINOR LAPAROTOMY CDS, Pack Number CDS860016P ;  15) MINOR LAPAROTOMY CDS, Pack Number CDS860016Q ;  16) MINOR LAPAROTOMY CDS, Pack Number CDS860016R ;  17) MINOR LAPAROTOMY CDS, Pack Number CDS860016S ;  18) THOROCOTOMY , Pack Number CDS860040I ;  19) LAPAROTOMY CDS #31-RF , Pack Number CDS860062Q ;  20) LAPAROTOMY CDS #31-RF , Pack Number CDS860062R ;  21) LAPAROTOMY CDS #31-RF , Pack Number CDS860062S ;  22) GYN LAP , Pack Number CDS860087K ;  23) GYN LAP , Pack Number CDS860087M ;  24) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107P ;  25) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107Q ;  26) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107R ;  27) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107S ;  28) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108K ;  29) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108L ;  30) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108M ;  31) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108N ;  32) LAP GASTRIC BYPASS CDS, Pack Number CDS860146J ;  33) LAP GASTRIC BYPASS CDS, Pack Number CDS860146K ;  34) LAP GASTRIC BYPASS CDS, Pack Number CDS860146L ;  35) LAP GASTRIC BYPASS CDS, Pack Number CDS860146M ;  36) ABDOMINAL ANEURYSM PROCEDURE, Pack Number CDS860181D ;  37) LAPAROSCOPY CDS , Pack Number CDS860194F ;  38) LAPAROSCOPY CDS , Pack Number CDS860194G ;  39) LAPAROSCOPY CDS , Pack Number CDS860194I ;  40) LAPAROSCOPY CDS , Pack Number CDS860229G ;  41) LAPAROSCOPY CDS-LF, Pack Number CDS860235G ;  42) LAPAROSCOPY CDS-LF, Pack Number CDS860235I ;  43) LAPAROSCOPY CDS-LF, Pack Number CDS860235J ;  44) BARI GASTRECTOMY CDS, Pack Number CDS860237AA;  45) BARI GASTRECTOMY CDS, Pack Number CDS860237AB;  46) BARI GASTRECTOMY CDS, Pack Number CDS860237AC;  47) BARI GASTRECTOMY CDS, Pack Number CDS860237X ;  48) BARI GASTRECTOMY CDS, Pack Number CDS860237Y ;  49) CYSTO , Pack Number CDS902753F ;  50) LAPAROSCOPIC CDS, Pack Number CDS920043T ;  51) BASIC LAPAROSCOPY CDS , Pack Number CDS920080P ;  52) BASIC LAPAROSCOPY CDS , Pack Number CDS920080Q ;  53) BASIC LAPAROSCOPY CDS , Pack Number CDS920080R ;  54) BASIC LAPAROSCOPY CDS , Pack Number CDS920080S ;  55) BASIC LAPAROSCOPY CDS , Pack Number CDS920080T ;  56) LAPAROSCOPIC, Pack Number CDS920082X ;  57) LAPAROSCOPIC, Pack Number CDS920082Y ;  58) LAPAROSCOPY CDS-LF, Pack Number CDS920104F ;  59) LAPAROSCOPY CDS-LF, Pack Number CDS920104G ;  60) LAPAROSCOPY CDS-LF, Pack Number CDS920104I ;  61) LAPAROSCOPY CDS-LF, Pack Number CDS920126AC;  62) GENERAL LAPAROSCOPY , Pack Number CDS930027T ;  63) GENERAL LAPAROSCOPY , Pack Number CDS930027U ;  64) GENERAL LAPAROSCOPY , Pack Number CDS930027V ;  65) LAP CHOLE CDS-LF, Pack Number CDS930030T ;  66) LAP CHOLE CDS-LF, Pack Number CDS930030U ;  67) LAP CHOLE , Pack Number CDS930089AA;  68) LAP CHOLE CDS , Pack Number CDS930111AA;  69) LAP CHOLE CDS , Pack Number CDS930111AB;  70) LAP CHOLE CDS-LF, Pack Number CDS930117J ;  71) MINOR BASIC-LF, Pack Number CDS930120G ;  72) MINOR BASIC-LF, Pack Number CDS930120I ;  73) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125R ;  74) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125S ;  75) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125T ;  76) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125U ;  77) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125V ;  78) (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-3006-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ;  2) LAVH CDS, Pack Number CDS760049AC;  3) LAPAROSCOPY CDS , Pack Number CDS760051AB;  4) LAPAROSCOPY CDS , Pack Number CDS760051AC;  5) LAPAROSCOPY CDS , Pack Number CDS760051AD;  6) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057G ;  7) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057I ;  8) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057J ;  9) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057K ;  10) CYSTO PROCEDURE , Pack Number CDS760062P ;  11) CYSTO PROCEDURE , Pack Number CDS760062Q ;  12) LAPAROSCOPY CDS , Pack Number CDS830216F ;  13) FETAL SURGERY CDS-LF, Pack Number CDS840214Q ;  14) MINOR LAPAROTOMY CDS, Pack Number CDS860016P ;  15) MINOR LAPAROTOMY CDS, Pack Number CDS860016Q ;  16) MINOR LAPAROTOMY CDS, Pack Number CDS860016R ;  17) MINOR LAPAROTOMY CDS, Pack Number CDS860016S ;  18) THOROCOTOMY , Pack Number CDS860040I ;  19) LAPAROTOMY CDS #31-RF , Pack Number CDS860062Q ;  20) LAPAROTOMY CDS #31-RF , Pack Number CDS860062R ;  21) LAPAROTOMY CDS #31-RF , Pack Number CDS860062S ;  22) GYN LAP , Pack Number CDS860087K ;  23) GYN LAP , Pack Number CDS860087M ;  24) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107P ;  25) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107Q ;  26) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107R ;  27) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107S ;  28) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108K ;  29) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108L ;  30) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108M ;  31) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108N ;  32) LAP GASTRIC BYPASS CDS, Pack Number CDS860146J ;  33) LAP GASTRIC BYPASS CDS, Pack Number CDS860146K ;  34) LAP GASTRIC BYPASS CDS, Pack Number CDS860146L ;  35) LAP GASTRIC BYPASS CDS, Pack Number CDS860146M ;  36) ABDOMINAL ANEURYSM PROCEDURE, Pack Number CDS860181D ;  37) LAPAROSCOPY CDS , Pack Number CDS860194F ;  38) LAPAROSCOPY CDS , Pack Number CDS860194G ;  39) LAPAROSCOPY CDS , Pack Number CDS860194I ;  40) LAPAROSCOPY CDS , Pack Number CDS860229G ;  41) LAPAROSCOPY CDS-LF, Pack Number CDS860235G ;  42) LAPAROSCOPY CDS-LF, Pack Number CDS860235I ;  43) LAPAROSCOPY CDS-LF, Pack Number CDS860235J ;  44) BARI GASTRECTOMY CDS, Pack Number CDS860237AA;  45) BARI GASTRECTOMY CDS, Pack Number CDS860237AB;  46) BARI GASTRECTOMY CDS, Pack Number CDS860237AC;  47) BARI GASTRECTOMY CDS, Pack Number CDS860237X ;  48) BARI GASTRECTOMY CDS, Pack Number CDS860237Y ;  49) CYSTO , Pack Number CDS902753F ;  50) LAPAROSCOPIC CDS, Pack Number CDS920043T ;  51) BASIC LAPAROSCOPY CDS , Pack Number CDS920080P ;  52) BASIC LAPAROSCOPY CDS , Pack Number CDS920080Q ;  53) BASIC LAPAROSCOPY CDS , Pack Number CDS920080R ;  54) BASIC LAPAROSCOPY CDS , Pack Number CDS920080S ;  55) BASIC LAPAROSCOPY CDS , Pack Number CDS920080T ;  56) LAPAROSCOPIC, Pack Number CDS920082X ;  57) LAPAROSCOPIC, Pack Number CDS920082Y ;  58) LAPAROSCOPY CDS-LF, Pack Number CDS920104F ;  59) LAPAROSCOPY CDS-LF, Pack Number CDS920104G ;  60) LAPAROSCOPY CDS-LF, Pack Number CDS920104I ;  61) LAPAROSCOPY CDS-LF, Pack Number CDS920126AC;  62) GENERAL LAPAROSCOPY , Pack Number CDS930027T ;  63) GENERAL LAPAROSCOPY , Pack Number CDS930027U ;  64) GENERAL LAPAROSCOPY , Pack Number CDS930027V ;  65) LAP CHOLE CDS-LF, Pack Number CDS930030T ;  66) LAP CHOLE CDS-LF, Pack Number CDS930030U ;  67) LAP CHOLE , Pack Number CDS930089AA;  68) LAP CHOLE CDS , Pack Number CDS930111AA;  69) LAP CHOLE CDS , Pack Number CDS930111AB;  70) LAP CHOLE CDS-LF, Pack Number CDS930117J ;  71) MINOR BASIC-LF, Pack Number CDS930120G ;  72) MINOR BASIC-LF, Pack Number CDS930120I ;  73) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125R ;  74) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125S ;  75) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125T ;  76) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125U ;  77) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125V ;  78)",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3006-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3006-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ;  2) LAVH CDS, Pack Number CDS760049AC;  3) LAPAROSCOPY CDS , Pack Number CDS760051AB;  4) LAPAROSCOPY CDS , Pack Number CDS760051AC;  5) LAPAROSCOPY CDS , Pack Number CDS760051AD;  6) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057G ;  7) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057I ;  8) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057J ;  9) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057K ;  10) CYSTO PROCEDURE , Pack Number CDS760062P ;  11) CYSTO PROCEDURE , Pack Number CDS760062Q ;  12) LAPAROSCOPY CDS , Pack Number CDS830216F ;  13) FETAL SURGERY CDS-LF, Pack Number CDS840214Q ;  14) MINOR LAPAROTOMY CDS, Pack Number CDS860016P ;  15) MINOR LAPAROTOMY CDS, Pack Number CDS860016Q ;  16) MINOR LAPAROTOMY CDS, Pack Number CDS860016R ;  17) MINOR LAPAROTOMY CDS, Pack Number CDS860016S ;  18) THOROCOTOMY , Pack Number CDS860040I ;  19) LAPAROTOMY CDS #31-RF , Pack Number CDS860062Q ;  20) LAPAROTOMY CDS #31-RF , Pack Number CDS860062R ;  21) LAPAROTOMY CDS #31-RF , Pack Number CDS860062S ;  22) GYN LAP , Pack Number CDS860087K ;  23) GYN LAP , Pack Number CDS860087M ;  24) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107P ;  25) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107Q ;  26) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107R ;  27) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107S ;  28) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108K ;  29) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108L ;  30) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108M ;  31) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108N ;  32) LAP GASTRIC BYPASS CDS, Pack Number CDS860146J ;  33) LAP GASTRIC BYPASS CDS, Pack Number CDS860146K ;  34) LAP GASTRIC BYPASS CDS, Pack Number CDS860146L ;  35) LAP GASTRIC BYPASS CDS, Pack Number CDS860146M ;  36) ABDOMINAL ANEURYSM PROCEDURE, Pack Number CDS860181D ;  37) LAPAROSCOPY CDS , Pack Number CDS860194F ;  38) LAPAROSCOPY CDS , Pack Number CDS860194G ;  39) LAPAROSCOPY CDS , Pack Number CDS860194I ;  40) LAPAROSCOPY CDS , Pack Number CDS860229G ;  41) LAPAROSCOPY CDS-LF, Pack Number CDS860235G ;  42) LAPAROSCOPY CDS-LF, Pack Number CDS860235I ;  43) LAPAROSCOPY CDS-LF, Pack Number CDS860235J ;  44) BARI GASTRECTOMY CDS, Pack Number CDS860237AA;  45) BARI GASTRECTOMY CDS, Pack Number CDS860237AB;  46) BARI GASTRECTOMY CDS, Pack Number CDS860237AC;  47) BARI GASTRECTOMY CDS, Pack Number CDS860237X ;  48) BARI GASTRECTOMY CDS, Pack Number CDS860237Y ;  49) CYSTO , Pack Number CDS902753F ;  50) LAPAROSCOPIC CDS, Pack Number CDS920043T ;  51) BASIC LAPAROSCOPY CDS , Pack Number CDS920080P ;  52) BASIC LAPAROSCOPY CDS , Pack Number CDS920080Q ;  53) BASIC LAPAROSCOPY CDS , Pack Number CDS920080R ;  54) BASIC LAPAROSCOPY CDS , Pack Number CDS920080S ;  55) BASIC LAPAROSCOPY CDS , Pack Number CDS920080T ;  56) LAPAROSCOPIC, Pack Number CDS920082X ;  57) LAPAROSCOPIC, Pack Number CDS920082Y ;  58) LAPAROSCOPY CDS-LF, Pack Number CDS920104F ;  59) LAPAROSCOPY CDS-LF, Pack Number CDS920104G ;  60) LAPAROSCOPY CDS-LF, Pack Number CDS920104I ;  61) LAPAROSCOPY CDS-LF, Pack Number CDS920126AC;  62) GENERAL LAPAROSCOPY , Pack Number CDS930027T ;  63) GENERAL LAPAROSCOPY , Pack Number CDS930027U ;  64) GENERAL LAPAROSCOPY , Pack Number CDS930027V ;  65) LAP CHOLE CDS-LF, Pack Number CDS930030T ;  66) LAP CHOLE CDS-LF, Pack Number CDS930030U ;  67) LAP CHOLE , Pack Number CDS930089AA;  68) LAP CHOLE CDS , Pack Number CDS930111AA;  69) LAP CHOLE CDS , Pack Number CDS930111AB;  70) LAP CHOLE CDS-LF, Pack Number CDS930117J ;  71) MINOR BASIC-LF, Pack Number CDS930120G ;  72) MINOR BASIC-LF, Pack Number CDS930120I ;  73) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125R ;  74) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125S ;  75) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125T ;  76) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125U ;  77) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125V ;  78)",
      "text": "The FDA logged enforcement record Z-3006-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ;  2) LAVH CDS, Pack Number CDS760049AC;  3) LAPAROSCOPY CDS , Pack Number CDS760051AB;  4) LAPAROSCOPY CDS , Pack Number CDS760051AC;  5) LAPAROSCOPY CDS , Pack Number CDS760051AD;  6) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057G ;  7) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057I ;  8) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057J ;  9) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057K ;  10) CYSTO PROCEDURE , Pack Number CDS760062P ;  11) CYSTO PROCEDURE , Pack Number CDS760062Q ;  12) LAPAROSCOPY CDS , Pack Number CDS830216F ;  13) FETAL SURGERY CDS-LF, Pack Number CDS840214Q ;  14) MINOR LAPAROTOMY CDS, Pack Number CDS860016P ;  15) MINOR LAPAROTOMY CDS, Pack Number CDS860016Q ;  16) MINOR LAPAROTOMY CDS, Pack Number CDS860016R ;  17) MINOR LAPAROTOMY CDS, Pack Number CDS860016S ;  18) THOROCOTOMY , Pack Number CDS860040I ;  19) LAPAROTOMY CDS #31-RF , Pack Number CDS860062Q ;  20) LAPAROTOMY CDS #31-RF , Pack Number CDS860062R ;  21) LAPAROTOMY CDS #31-RF , Pack Number CDS860062S ;  22) GYN LAP , Pack Number CDS860087K ;  23) GYN LAP , Pack Number CDS860087M ;  24) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107P ;  25) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107Q ;  26) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107R ;  27) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107S ;  28) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108K ;  29) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108L ;  30) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108M ;  31) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108N ;  32) LAP GASTRIC BYPASS CDS, Pack Number CDS860146J ;  33) LAP GASTRIC BYPASS CDS, Pack Number CDS860146K ;  34) LAP GASTRIC BYPASS CDS, Pack Number CDS860146L ;  35) LAP GASTRIC BYPASS CDS, Pack Number CDS860146M ;  36) ABDOMINAL ANEURYSM PROCEDURE, Pack Number CDS860181D ;  37) LAPAROSCOPY CDS , Pack Number CDS860194F ;  38) LAPAROSCOPY CDS , Pack Number CDS860194G ;  39) LAPAROSCOPY CDS , Pack Number CDS860194I ;  40) LAPAROSCOPY CDS , Pack Number CDS860229G ;  41) LAPAROSCOPY CDS-LF, Pack Number CDS860235G ;  42) LAPAROSCOPY CDS-LF, Pack Number CDS860235I ;  43) LAPAROSCOPY CDS-LF, Pack Number CDS860235J ;  44) BARI GASTRECTOMY CDS, Pack Number CDS860237AA;  45) BARI GASTRECTOMY CDS, Pack Number CDS860237AB;  46) BARI GASTRECTOMY CDS, Pack Number CDS860237AC;  47) BARI GASTRECTOMY CDS, Pack Number CDS860237X ;  48) BARI GASTRECTOMY CDS, Pack Number CDS860237Y ;  49) CYSTO , Pack Number CDS902753F ;  50) LAPAROSCOPIC CDS, Pack Number CDS920043T ;  51) BASIC LAPAROSCOPY CDS , Pack Number CDS920080P ;  52) BASIC LAPAROSCOPY CDS , Pack Number CDS920080Q ;  53) BASIC LAPAROSCOPY CDS , Pack Number CDS920080R ;  54) BASIC LAPAROSCOPY CDS , Pack Number CDS920080S ;  55) BASIC LAPAROSCOPY CDS , Pack Number CDS920080T ;  56) LAPAROSCOPIC, Pack Number CDS920082X ;  57) LAPAROSCOPIC, Pack Number CDS920082Y ;  58) LAPAROSCOPY CDS-LF, Pack Number CDS920104F ;  59) LAPAROSCOPY CDS-LF, Pack Number CDS920104G ;  60) LAPAROSCOPY CDS-LF, Pack Number CDS920104I ;  61) LAPAROSCOPY CDS-LF, Pack Number CDS920126AC;  62) GENERAL LAPAROSCOPY , Pack Number CDS930027T ;  63) GENERAL LAPAROSCOPY , Pack Number CDS930027U ;  64) GENERAL LAPAROSCOPY , Pack Number CDS930027V ;  65) LAP CHOLE CDS-LF, Pack Number CDS930030T ;  66) LAP CHOLE CDS-LF, Pack Number CDS930030U ;  67) LAP CHOLE , Pack Number CDS930089AA;  68) LAP CHOLE CDS , Pack Number CDS930111AA;  69) LAP CHOLE CDS , Pack Number CDS930111AB;  70) LAP CHOLE CDS-LF, Pack Number CDS930117J ;  71) MINOR BASIC-LF, Pack Number CDS930120G ;  72) MINOR BASIC-LF, Pack Number CDS930120I ;  73) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125R ;  74) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125S ;  75) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125T ;  76) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125U ;  77) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125V ;  78) — 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: 7791 , Lot Number 19CDC814 ;  7791 , Lot Number 19EDB234 ;  7791 , Lot Number 19EDC967 ;  7791 , Lot Number 19FDD341 ;  7791 , Lot Number 19GDA594 ;  7791 , Lot Number 19HDC417 ;  7791 , Lot Number 19IDC356 ;  7791 , Lot Number 19KDB323 ;  7791 , Lot Number 19KDB955 ;  7791 , Lot Number 21KDB873 ;  7791 , Lot Number 22CDA330 ;  7791 , Lot Number 22CDA484 ;  7791 , Lot Number 22CDB460 ;  CDS760049AC, Lot Number 19KBT844 ;  CDS760049AC, Lot Number 20ABJ873 ;  CDS760049AC, Lot Number 20BBW737 ;  CDS760049AC, Lot Number 20DBL004 ;  CDS760049AC, Lot Number 20GBJ882 ;  CDS760049AC, Lot Number 20IBH018 ;  CDS760049AC, Lot Number 20LBP200 ;  CDS760049AC, Lot Number 21ABB006 ;  CDS760049AC, Lot Number 21EBA024 ;  CDS760049AC, Lot Number 21EBI363 ;  CDS760051AB, Lot Number 19ABI119 ;  CDS760051AB, Lot Number 19BBP260 ;  CDS760051AB, Lot Number 19EBK100 ;  CDS760051AB, Lot Number 19EBK170 ;  CDS760051AB, Lot Number 19GBH718 ;  CDS760051AB, Lot Number 19SBB540 ;  CDS760051AB, Lot Number 19SBE251 ;  CDS760051AB, Lot Number 19JBP888 ;  CDS760051AB, Lot Number 19LBL746 ;  CDS760051AC, Lot Number 19WBA844 ;  CDS760051AC, Lot Number 19LBY065 ;  CDS760051AC, Lot Number 20BBA091 ;  CDS760051AC, Lot Number 20BBT794 ;  CDS760051AC, Lot Number 20EBU286 ;  CDS760051AC, Lot Number 20FBL605 ;  CDS760051AC, Lot Number 20GBV069 ;  CDS760051AC, Lot Number 20HBO480 ;  CDS760051AC, Lot Number 20JBQ421 ;  CDS760051AC, Lot Number 20KBL963 ;  CDS760051AC, Lot Number 20LBB516 ;  CDS760051AC, Lot Number 20LBU992 ;  CDS760051AC, Lot Number 21DBV508 ;  CDS760051AD, Lot Number 21FBU465 ;  CDS760051AD, Lot Number 21HBG002 ;  CDS760051AD, Lot Number 21IBP855 ;  CDS760051AD, Lot Number 21KBZ599 ;  CDS760051AD, Lot Number 21KBZ600 ;  CDS760051AD, Lot Number 22DBD548 ;  CDS760051AD, Lot Number 22DBG405 ;  CDS760051AD, Lot Number 22FBB185 ;  CDS760051AD, Lot Number 22FBI490 ;  CDS760051AD, Lot Number 22GBD299 ;  CDS760051AD, Lot Number 22GBU498 ;  CDS760051AD, Lot Number 22IBS739 ;  CDS760051AD, Lot Number 22JBF777 ;  CDS760051AD, Lot Number 22JBR836 ;  CDS760051AD, Lot Number 22KBS068 ;  CDS760051AD, Lot Number 23BBG604 ;  CDS760051AD, Lot Number 23CBG879 ;  CDS760051AD, Lot Number 23FBC729 ;  CDS760051AD, Lot Number 23GBD240 ;  CDS760051AD, Lot Number 23IBB494 ;  CDS760051AD, Lot Number 23IBO569 ;  CDS760051AD, Lot Number 23LBE145 ;  CDS760051AD, Lot Number 24BBM779 ;  CDS760057G , Lot Number 19ABH764 ;  CDS760057G , Lot Number 19ABL825 ;  CDS760057G , Lot Number 19BBA476 ;  CDS760057G , Lot Number 19CBT401 ;  CDS760057G , Lot Number 19EBA903 ;  CDS760057G , Lot Number 19FBD872 ;  CDS760057G , Lot Number 19GBP568 ;  CDS760057G , Lot Number 19SBF513 ;  CDS760057G , Lot Number 19HBN041 ;  CDS760057G , Lot Number 19KBN171 ;  CDS760057G , Lot Number 19LBQ707 ;  CDS760057G , Lot Number 20BBS579 ;  CDS760057G , Lot Number 20OBA112 ;  CDS760057I , Lot Number 21FBM605 ;  CDS760057I , Lot Number 21HBR385 ;  CDS760057I , Lot Number 21IBK118 ;  CDS760057I , Lot Number 20EBF638 ;  CDS760057I , Lot Number 20GBA315 ;  CDS760057I , Lot Number 20HBE854 ;  CDS760057I , Lot Number 20IBS984 ;  CDS760057I , Lot Number 20KBC976 ;  CDS760057I , Lot Number 20LBO858 ;  CDS760057I , Lot Number 21BBK105 ;  CDS760057I , Lot Number 21CBW931 ;  CDS760057I , Lot Number 21EBC903 ;  CDS760057J , Lot Number 21JBX790 ;  CDS760057J , Lot Number 21LBV289 ;  CDS760057J , Lot Number 22NBE608 ;  CDS760057J , Lot Number 22OBK791 ;  CDS760057J , Lot Number 22DBR270 ;  CDS760057J , Lot Number 22FBE976 ;  CDS760057J , Lot Number 22FBX954 ;  CDS760057J , Lot Number 22HBO176 ;  CDS760057J , Lot Number 22HBO511 ;  CDS760057K , Lot Number 22LBC409 ;  CDS760057K , Lot Number 23ABU244 ;  CDS760057K , Lot Number 23CBO552 ;  CDS760057K , Lot Number 23CBT750 ;  CDS760057K , Lot Number 23EBA183 ;  CDS760057K , Lot Number 23EBP896 ;  CDS760057K , Lot Number 23GBN928 ;  CDS760057K , Lot Number 23IBC604 ;  CDS760057K , Lot Number 23JBH987 ;  CDS760062P , Lot Number 21FBI200 ;  CDS760062P , Lot Number 21HBA510 ;  CDS760062P , Lot Number 21IBL982 ;  CDS760062P , Lot Number 21KBF471 ;  CDS760062P , Lot Number 22BBR315 ;  CDS760062P , Lot Number 22BBR316 ;  CDS760062P , Lot Number 22OBM499 ;  CDS760062P , Lot Number 22GBA062 ;  CDS760062P , Lot Number 22IBQ978 ;  CDS760062P , Lot Number 22LBE467 ;  CDS760062P , Lot Number 23ABU387 ;  CDS760062P , Lot Number 23CBP305 ;  CDS760062P , Lot Number 23EBG915 ;  CDS760062P , Lot Number 23FBU586 ;  CDS760062P , Lot Number 23HBN718 ;  CDS760062P , Lot Number 21ABU305 ;  CDS760062P , Lot Number 21EBE907 ;  CDS760062Q , Lot Number 23KBC964 ;  CDS760062Q , Lot Number 23LBD670 ;  CDS830216F , Lot Number 21FMB272 ;  CDS830216F , Lot Number 21FME648 ;  CDS830216F , Lot Number 21IMA939 ;  CDS830216F , Lot Number 21IMH645 ;  CDS830216F , Lot Number 22AMC537 ;  CDS830216F , Lot Number 22CME417 ;  CDS830216F , Lot Number 22EME098 ;  CDS830216F , Lot Number 22HMF279 ;  CDS830216F , Lot Number 22IMH576 ;  CDS830216F , Lot Number 22LMH113 ;  CDS830216F , Lot Number 23AMB967 ;  CDS830216F , Lot Number 23AMH591 ;  CDS830216F , Lot Number 23BMC494 ;  CDS830216F , Lot Number 23BMD518 ;  CDS830216F , Lot Number 24AMH917 ;  CDS830216F , Lot Number 19CKA634 ;  CDS830216F , Lot Number 19EKD500 ;  CDS830216F , Lot Number 19FKC553 ;  CDS830216F , Lot Number 19HKC286 ;  CDS830216F , Lot Number 19JKC134 ;  CDS830216F , Lot Number 19LKB586 ;  CDS830216F , Lot Number 20AKC087 ;  CDS830216F , Lot Number 20CKB663 ;  CDS830216F , Lot Number 20EKB752 ;  CDS830216F , Lot Number 20IKA845 ;  CDS830216F , Lot Number 20LKA596 ;  CDS830216F , Lot Number 21AKA048 ;  CDS830216F , Lot Number 21DKA286 ;  CDS830216F , Lot Number 21EKA122 ;  CDS840214Q , Lot Number 22LBL682 ;  CDS840214Q , Lot Number 23DBM331 ;  CDS840214Q , Lot Number 23GBA625 ;  CDS840214Q , Lot Number 23GBI439 ;  CDS840214Q , Lot Number 23IBC884 ;  CDS860016P , Lot Number 21GBV761 ;  CDS860016P , Lot Number 21GBV762 ;  CDS860016P , Lot Number 21KBI389 ;  CDS860016P , Lot Number 22ABD367 ;  CDS860016P , Lot Number 22BBL530 ;  CDS860016P , Lot Number 22FBH684 ;  CDS860016P , Lot Number 22FBQ637 ;  CDS860016P , Lot Number 21EBD212 ;  CDS860016P , Lot Number 21FBC634 ;  CDS860016Q , Lot Number 22JBE511 ;  CDS860016Q , Lot Number 22KBA835 ;  CDS860016Q , Lot Number 23ABM653 ;  CDS860016R , Lot Number 23GBD634 ;  CDS860016R , Lot Number 23IBO655 ;  CDS860016R , Lot Number 23KBP519 ;  CDS860016R , Lot Number 24BBK121 ;  CDS860016S , Lot Number 24CBD741 ;  CDS860040I , Lot Number 19BLA032 ;  CDS860040I , Lot Number 19CLA477 ;  CDS860040I , Lot Number 19ELA508 ;  CDS860040I , Lot Number 19FLA130 ;  CDS860040I , Lot Number 19GLA472 ;  CDS860040I , Lot Number 19JLA007 ;  CDS860040I , Lot Number 19LLA159 ;  CDS860040I , Lot Number 20CLA554 ;  CDS860040I , Lot Number 20DLA308 ;  CDS860040I , Lot Number 20ELA046 ;  CDS860040I , Lot Number 20ELA310 ;  CDS860040I , Lot Number 20ELA745 ;  CDS860062Q , Lot Number 19ABL813 ;  CDS860062Q , Lot Number 19BBK857 ;  CDS860062Q , Lot Number 19CBD977 ;  CDS860062Q , Lot Number 19CBX786 ;  CDS860062Q , Lot Number 19FBW524 ;  CDS860062Q , Lot Number 19GBC360 ;  CDS860062Q , Lot Number 19JBU878 ;  CDS860062Q , Lot Number 19JBZ535 ;  CDS860062Q , Lot Number 19LBA496 ;  CDS860062Q , Lot Number 20BBQ470 ;  CDS860062Q , Lot Number 20DBH055 ;  CDS860062Q , Lot Number 20GBB627 ;  CDS860062Q , Lot Number 20HBU687 ;  CDS860062Q , Lot Number 20XBI627 ;  CDS860062Q , Lot Number 21BBQ503 ;  CDS860062R , Lot Number 21FBN759 ;  CDS860062R , Lot Number 21HBF180 ;  CDS860062R , Lot Number 21IBV652 ;  CDS860062R , Lot Number 21LBQ908 ;  CDS860062R , Lot Number 22OBA906 ;  CDS860062R , Lot Number 22OBE627 ;  CDS860062R , Lot Number 22DBJ333 ;  CDS860062R , Lot Number 21EBA127 ;  CDS860062S , Lot Number 22GBO814 ;  CDS860062S , Lot Number 22GBS435 ;  CDS860062S , Lot Number 22IBE017 ;  CDS860062S , Lot Number 22IBR065 ;  CDS860062S , Lot Number 23ABG350 ;  CDS860062S , Lot Number 23BBN766 ;  CDS860062S , Lot Number 23DBG817 ;  CDS860062S , Lot Number 23EBQ675 ;  CDS860062S , Lot Number 23HBL645 ;  CDS860062S , Lot Number 23HBP450 ;  CDS860062S , Lot Number 23JBD395 ;  CDS860062S , Lot Number 24ABB879 ;  CDS860087K , Lot Number 19BBM893 ;  CDS860087K , Lot Number 19DBL394 ;  CDS860087K , Lot Number 19EBY134 ;  CDS860087K , Lot Number 19RBD402 ;  CDS860087K , Lot Number 19GBX983 ;  CDS860087K , Lot Number 19HBQ980 ;  CDS860087K , Lot Number 19JBA273 ;  CDS860087K , Lot Number 19WBA857 ;  CDS860087K , Lot Number 20CBP234 ;  CDS860087K , Lot Number 20HBG093 ;  CDS860087M , Lot Number 21IBW771 ;  CDS860087M , Lot Number 21IBW774 ;  CDS860087M , Lot Number 22CBW161 ;  CDS860087M , Lot Number 22CBW162 ;  CDS860087M , Lot Number 22DBR240 ;  CDS860087M , Lot Number 22FBV480 ;  CDS860087M , Lot Number 22FBV482 ;  CDS860087M , Lot Number 22HBR848 ;  CDS860087M , Lot Number 22KBJ841 ;  CDS860087M , Lot Number 23BBI313 ;  CDS860087M , Lot Number 23CBX423 ;  CDS860087M , Lot Number 23DBM046 ;  CDS860087M , Lot Number 23EBN735 ;  CDS860087M , Lot Number 23EBW562 ;  CDS860087M , Lot Number 23FBP611 ;  CDS860087M , Lot Number 23HBP619 ;  CDS860087M , Lot Number 23JBU719 ;  CDS860087M , Lot Number 24ABD431 ;  CDS860087M , Lot Number 24CBK279 ;  CDS860107P , Lot Number 19GBW170 ;  CDS860107P , Lot Number 19HBX216 ;  CDS860107P , Lot Number 19IBC347 ;  CDS860107P , Lot Number 19IBE970 ;  CDS860107P , Lot Number 19JBZ272 ;  CDS860107P , Lot Number 19KBD935 ;  CDS860107P , Lot Number 20ABN396 ;  CDS860107P , Lot Number 20BBW913 ;  CDS860107P , Lot Number 20FBF671 ;  CDS860107P , Lot Number 20GBJ670 ;  CDS860107P , Lot Number 20IBC311 ;  CDS860107Q , Lot Number 21HBI283 ;  CDS860107Q , Lot Number 21IBR058 ;  CDS860107Q , Lot Number 21LBE762 ;  CDS860107Q , Lot Number 20KBG236 ;  CDS860107Q , Lot Number 20LBD272 ;  CDS860107Q , Lot Number 21ABG515 ;  CDS860107R , Lot Number 22DBL814 ;  CDS860107R , Lot Number 22EBA244 ;  CDS860107R , Lot Number 22EBE607 ;  CDS860107S , Lot Number 23CBP690 ;  CDS860107S , Lot Number 23GBT365 ;  CDS860107S , Lot Number 23IBK291 ;  CDS860107S , Lot Number 23IBQ708 ;  CDS860107S , Lot Number 23IBU193 ;  CDS860108K , Lot Number 21FBN778 ;  CDS860108K , Lot Number 21HBH194 ;  CDS860108K , Lot Number 21IBM921 ;  CDS860108K , Lot Number 19ABQ394 ;  CDS860108K , Lot Number 19BBG692 ;  CDS860108K , Lot Number 19DBA624 ;  CDS860108K , Lot Number 19DBU636 ;  CDS860108K , Lot Number 19EBZ561 ;  CDS860108K , Lot Number 19FBP651 ;  CDS860108K , Lot Number 19GBD177 ;  CDS860108K , Lot Number 19SBH379 ;  CDS860108K , Lot Number 19HBS816 ;  CDS860108K , Lot Number 19JBC012 ;  CDS860108K , Lot Number 19KBO556 ;  CDS860108K , Lot Number 20BBQ508 ;  CDS860108K , Lot Number 20DBL011 ;  CDS860108K , Lot Number 20GBK481 ;  CDS860108K , Lot Number 20GBQ712 ;  CDS860108K , Lot Number 20KBS330 ;  CDS860108K , Lot Number 20LBD018 ;  CDS860108K , Lot Number 21ABC392 ;  CDS860108K , Lot Number 21ABL309 ;  CDS860108K , Lot Number 21BBE921 ;  CDS860108K , Lot Number 21BBF989 ;  CDS860108K , Lot Number 21DBF097 ;  CDS860108L , Lot Number 21LBC324 ;  CDS860108M , Lot Number 22NBD509 ;  CDS860108M , Lot Number 22CBM719 ; 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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-3006-2024&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-3006-2024&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-3006-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3006-2024 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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3006-2024&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-3006-2024&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-3006-2024/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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        "supported": true,
        "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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          "@type": "schema:ListItem",
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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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        },
        {
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          "item": {
            "Field": "Initiated",
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 CDS920104G , Lot Number 23FBS241 ;  CDS920104G , Lot Number 20DBF121 ;  CDS920104G , Lot Number 20DBQ083 ;  CDS920104G , Lot Number 23HBY251 ;  CDS920104G , Lot Number 20FBI378 ;  CDS920104G , Lot Number 20IBG102 ;  CDS920104G , Lot Number 21BBN524 ;  CDS920104G , Lot Number 21CBI437 ;  CDS920104G , Lot Number 21FBB108 ;  CDS920104I , Lot Number 23KBC703 ;  CDS920104I , Lot Number 24ABI142 ;  CDS920104I , Lot Number 24ABN324 ;  CDS920126AC, Lot Number 23EMI777 ;  CDS920126AC, Lot Number 23FMG082 ;  CDS920126AC, Lot Number 23HMF743 ;  CDS920126AC, Lot Number 23HMH041 ;  CDS920126AC, Lot Number 23JMF264 ;  CDS920126AC, Lot Number 23LMA927 ;  CDS930027T , Lot Number 19BBA759 ;  CDS930027T , Lot Number 19CBM946 ;  CDS930027T , Lot Number 19EBM805 ;  CDS930027T , Lot Number 19RBC090 ;  CDS930027T , Lot Number 19IBU719 ;  CDS930027T , Lot Number 19VBH003 ;  CDS930027T , Lot Number 20ABS564 ;  CDS930027T , Lot Number 20CBF531 ;  CDS930027U , Lot Number 21GBV752 ;  CDS930027U , Lot Number 21HBK319 ; 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 CDS930030T , Lot Number 19FBM121 ;  CDS930030T , Lot Number 19GBM872 ;  CDS930030T , Lot Number 19TBC908 ;  CDS930030T , Lot Number 19JBX099 ;  CDS930030T , Lot Number 19KBZ809 ;  CDS930030T , Lot Number 19LBU162 ;  CDS930030T , Lot Number 20CBL945 ;  CDS930030T , Lot Number 20DBD766 ;  CDS930030T , Lot Number 20EBO466 ;  CDS930030T , Lot Number 20GBB536 ;  CDS930030U , Lot Number 20KBT203 ;  CDS930030U , Lot Number 21BBG083 ;  CDS930030U , Lot Number 21CBJ270 ;  CDS930030U , Lot Number 21DBU055 ;  CDS930089AA, Lot Number 21GBU903 ;  CDS930089AA, Lot Number 21HBL112 ;  CDS930089AA, Lot Number 21LBF061 ;  CDS930089AA, Lot Number 22ABA351 ;  CDS930089AA, Lot Number 22ABT863 ;  CDS930089AA, Lot Number 19BBI392 ;  CDS930089AA, Lot Number 22CBZ082 ;  CDS930089AA, Lot Number 22OBI153 ;  CDS930089AA, Lot Number 19CBO430 ;  CDS930089AA, Lot Number 19PBB793 ;  CDS930089AA, Lot Number 22FBR220 ;  CDS930089AA, Lot Number 22GBM173 ;  CDS930089AA, Lot Number 19FBT057 ;  CDS930089AA, Lot Number 19HBV784 ;  CDS930089AA, Lot Number 19IBZ336 ;  CDS930089AA, Lot Number 22LBG829 ;  CDS930089AA, Lot Number 23ABM683 ;  CDS930089AA, Lot Number 19VBF797 ;  CDS930089AA, Lot Number 19LBU147 ;  CDS930089AA, Lot Number 23DBQ286 ;  CDS930089AA, Lot Number 20BBB545 ;  CDS930089AA, Lot Number 23FBC727 ;  CDS930089AA, Lot Number 23FBU034 ;  CDS930089AA, Lot Number 23GBN307 ;  CDS930089AA, Lot Number 20CBW907 ;  CDS930089AA, Lot Number 20EBE543 ;  CDS930089AA, Lot Number 20EBI717 ;  CDS930089AA, Lot Number 23JBD587 ;  CDS930089AA, Lot Number 20GBB110 ;  CDS930089AA, Lot Number 20GBJ929 ;  CDS930089AA, Lot Number 23KBH971 ;  CDS930089AA, Lot Number 23LBF456 ;  CDS930089AA, Lot Number 20JBD444 ;  CDS930089AA, Lot Number 20JBM306 ;  CDS930089AA, Lot Number 21BBS512 ;  CDS930089AA, Lot Number 21DBP220 ;  CDS930089AA, Lot Number 21EBK873 ;  CDS930111AA, Lot Number 20ABL112 ;  CDS930111AA, Lot Number 20CBC241 ;  CDS930111AA, Lot Number 20GBB526 ;  CDS930111AA, Lot Number 20HBO487 ;  CDS930111AA, Lot Number 20LBS202 ;  CDS930111AA, Lot Number 21CBP654 ;  CDS930111AB, Lot Number 21IBJ205 ;  CDS930111AB, Lot Number 21IBK117 ;  CDS930111AB, Lot Number 21IBW760 ;  CDS930111AB, Lot Number 21JBF950 ;  CDS930111AB, Lot Number 21KBI384 ;  CDS930111AB, Lot Number 21LBV273 ;  CDS930111AB, Lot Number 22BBN366 ;  CDS930111AB, Lot Number 22CBX116 ;  CDS930111AB, Lot Number 22OBM495 ;  CDS930111AB, Lot Number 22EBK391 ;  CDS930111AB, Lot Number 22FBS263 ;  CDS930111AB, Lot Number 22HBS336 ;  CDS930111AB, Lot Number 22JBP072 ;  CDS930111AB, Lot Number 22KBN952 ;  CDS930111AB, Lot Number 23ABS830 ;  CDS930111AB, Lot Number 23DBE031 ;  CDS930111AB, Lot Number 23FBA347 ;  CDS930111AB, Lot Number 23GBV748 ;  CDS930111AB, Lot Number 23HBY074 ;  CDS930111AB, Lot Number 23JBW674 ;  CDS930111AB, Lot Number 24ABB946 ;  CDS930117J , Lot Number 21FBJ128 ;  CDS930117J , Lot Number 21HBC602 ;  CDS930117J , Lot Number 21KBF379 ;  CDS930117J , Lot Number 21LBC688 ;  CDS930117J , Lot Number 22MBA147 ;  CDS930117J , Lot Number 19ABV527 ;  CDS930117J , Lot Number 19CBA601 ;  CDS930117J , Lot Number 22OBB425 ;  CDS930117J , Lot Number 22OBJ624 ;  CDS930117J , Lot Number 19DBD054 ;  CDS930117J , Lot Number 19EBH984 ;  CDS930117J , Lot Number 22FBG748 ;  CDS930117J , Lot Number 22FBN280 ;  CDS930117J , Lot Number 19FBN226 ;  CDS930117J , Lot Number 22GBS430 ;  CDS930117J , Lot Number 22HBO683 ;  CDS930117J , Lot Number 19HBW390 ;  CDS930117J , Lot Number 22JBL434 ;  CDS930117J , Lot Number 22LBH539 ;  CDS930117J , Lot Number 23ABD136 ;  CDS930117J , Lot Number 19VBF652 ;  CDS930117J , Lot Number 19LBE159 ;  CDS930117J , Lot Number 20BBE291 ;  CDS930117J , Lot Number 20DBB687 ;  CDS930117J , Lot Number 20FBJ067 ;  CDS930117J , Lot Number 20HBG826 ;  CDS930117J , Lot Number 20JBU664 ;  CDS930117J , Lot Number 20LBG120 ;  CDS930117J , Lot Number 21CBI120 ;  CDS930120G , Lot Number 21JBX687 ;  CDS930120G , Lot Number 21KBO560 ;  CDS930120G , Lot Number 21LBI714 ;  CDS930120G , Lot Number 22OBD872 ;  CDS930120G , Lot Number 22FBF472 ;  CDS930120G , Lot Number 22FBV562 ;  CDS930120G , Lot Number 22HBE369 ;  CDS930120G , Lot Number 22HBS333 ;  CDS930120G , Lot Number 22IBU622 ;  CDS930120G , Lot Number 22JBG904 ;  CDS930120G , Lot Number 22JBL442 ;  CDS930120G , Lot Number 22KBI260 ;  CDS930120G , Lot Number 22LBT330 ;  CDS930120G , Lot Number 23ABQ984 ;  CDS930120G , Lot Number 23BBG709 ;  CDS930120G , Lot Number 23EBD647 ;  CDS930120G , Lot Number 23HBS779 ;  CDS930120G , Lot Number 23HBS920 ;  CDS930120G , Lot Number 23JBJ078 ;  CDS930120I , Lot Number 23KBP659 ;  CDS930125R , Lot Number 19ABX208 ;  CDS930125R , Lot Number 19BBU623 ;  CDS930125R , Lot Number 19PBB795 ;  CDS930125R , Lot Number 19FBO219 ;  CDS930125R , Lot Number 19TBC174 ;  CDS930125R , Lot Number 19IBE433 ;  CDS930125R , Lot Number 19JBT783 ;  CDS930125R , Lot Number 19KBH808 ;  CDS930125R , Lot Number 19LBL963 ;  CDS930125R , Lot Number 20ABZ988 ;  CDS930125R , Lot Number 20CBF694 ;  CDS930125R , Lot Number 20DBB574 ;  CDS930125R , Lot Number 20EBM625 ;  CDS930125R , Lot Number 20EBO407 ;  CDS930125S , Lot Number 20HBJ896 ;  CDS930125T , Lot Number 21FBP666 ;  CDS930125T , Lot Number 21HBK248 ;  CDS930125T , Lot Number 21HBV013 ;  CDS930125T , Lot Number 21ABO338 ;  CDS930125T , Lot Number 21CBD702 ;  CDS930125T , Lot Number 21DBT977 ;  CDS930125T , Lot Number 21EBO614 ;  CDS930125U , Lot Number 22ABW424 ;  CDS930125U , Lot Number 22DBS504 ;  CDS930125U , Lot Number 22FBV303 ;  CDS930125U , Lot Number 22GBU110 ;  CDS930125V , Lot Number 22JBA038 ;  CDS930125V , Lot Number 22JBH334 ;  CDS930125V , Lot Number 23BBA847 ;  CDS930125V , Lot Number 23BBA853 ;  CDS930125V , Lot Number 23BBG453 ;  CDS930125V , Lot Number 23DBE116 ;  CDS930125V , Lot Number 23GBJ662 ;  CDS930125V , Lot Number 23HBL229 ;  CDS930125V , Lot Number 23JBB241 ;  CDS930137G , Lot Number 19BBU032 ;  CDS930161C , Lot Number 21IBG798 ;  CDS930161C , Lot Number 21KBH053 ;  CDS930161C , Lot Number 22ABC108 ;  CDS930161C , Lot Number 19ABP758 ;  CDS930161C , Lot Number 19BBS825 ;  CDS930161C , Lot Number 19DBO528 ;  CDS930161C , Lot Number 22EBN080 ;  CDS930161C , Lot Number 19EBR982 ;  CDS930161C , Lot Number 22GBP737 ;  CDS930161C , Lot Number 19FBZ168 ;  CDS930161C , Lot Number 19VBA661 ;  CDS930161C , Lot Number 20ABI300 ;  CDS930161C , Lot Number 20ABX988 ;  CDS930161C , Lot Number 20CBA339 ;  CDS930161C , Lot Number 20DBD796 ;  CDS930161C , Lot Number 20EBO424 ;  CDS930161C , Lot Number 20FBR036 ;  CDS930161C , Lot Number 20GBQ391 ;  CDS930161C , Lot Number 20VBB224 ;  CDS930161C , Lot Number 20KBL968 ;  CDS930161C , Lot Number 21DBS567 ;  CDS930161C , Lot Number 21EBE941 ;  CDS930161C , Lot Number 21EBQ935 ;  CDS930161C , Lot Number 22IMD546 ;  CDS930161C , Lot Number 23AMF086 ;  CDS930161C , Lot Number 23FMI179 ;  CDS930161C , Lot Number 23GMI714 ;  CDS930161D , Lot Number 23KMH438 ;  CDS930161D , Lot Number 24AMH879 ;  CDS930191R , Lot Number 19ABX734 ;  CDS930191R , Lot Number 19BBL857 ;  CDS930191R , Lot Number 19CBJ262 ;  CDS930191R , Lot Number 19PBB306 ;  CDS930191S , Lot Number 19FBA457 ;  CDS930191T , Lot Number 19HBH294 ;  CDS930191T , Lot Number 19IBY458 ;  CDS930191T , Lot Number 19VBF320 ;  CDS930191T , Lot Number 19LBN303 ;  CDS930191T , Lot Number 19LBY064 ;  CDS930191T , Lot Number 20CBJ831 ;  CDS930191T , Lot Number 20DBB180 ;  CDS930191T , Lot Number 20DBD283 ;  CDS930191T , Lot Number 20",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}