{
  "@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-3046-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) LAVH CDS, Pack Number CDS760049AB;  2) TUBAL LIGATION CDS, Pack Number CDS760053D ;  3) TUBAL LIGATION CDS, Pack Number CDS760053G ;  4) TUBAL LIGATION CDS, Pack Number CDS760053I ;  5) TUBAL LIGATION CDS, Pack Number CDS760053J ;  6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ;  7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ;  8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ;  9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ;  10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ;  11) GYN LAP , Pack Number CDS860087L ;  12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ;  13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ;  14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ;  15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ;  16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ;  17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ;  18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ;  19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ;  20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH;  21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ;  22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ;  23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ;  24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ;  25) LAVH CDS, Pack Number CDS920130J ;  26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ;  27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ;  28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ;  29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ;  30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ;  31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ;  32) GYN LAPAROSCOPIC, Pack Number CDS930224I ;  33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ;  34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ;  35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ;  36) ROBOTIC , Pack Number CDS980523M ;  37) ROBOTIC GYN , Pack Number CDS980647K ;  38) GYN LAP PROCEDURE , Pack Number CDS980810O ;  39) GYN LAP PROCEDURE , Pack Number CDS980810P ;  40) GYN LAP PROCEDURE , Pack Number CDS980810Q ;  41) GYN LAPAROSCOPY , Pack Number CDS980843G ;  42) GYN LAPAROSCOPY , Pack Number CDS980843I ;  43) DAVINCI PROCEDURE , Pack Number CDS980864O ;  44) DAVINCI PROCEDURE , Pack Number CDS980864P ;  45) GYN MAJOR CDS , Pack Number CDS980998J ;  46) GYN MAJOR , Pack Number CDS980998L ;  47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ;  48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ;  49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ;  50) PELVISCOPY CDS, Pack Number CDS981546F ;  51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ;  52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ;  53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ;  54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ;  55) GYN DAVINCI CDS , Pack Number CDS981606F ;  56) ROBOTIC PACK-LF , Pack Number CDS981757Q ;  57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ;  58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ;  59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ;  60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ;  61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ;  62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ;  63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ;  64) ROBOTIC CDS , Pack Number CDS981882W ;  65) ROBOTIC CDS , Pack Number CDS981882X ;  66) LITHOTOMY CDS , Pack Number CDS981897S ;  67) LITHOTOMY CDS , Pack Number CDS981897T ;  68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ;  69) GYN LAPAROSCOPY , Pack Number CDS982032U ;  70) GYN LAPAROSCOPY , Pack Number CDS982032V ;  71) GYN LAPAROSCOPY , Pack Number CDS982032W ;  72) GYN LAPAROSCOPY , Pack Number CDS982032X ;  73) GYN LAPAROSCOPY , Pack Number CDS982032Y ;  74) ROBOTIC , Pack Number CDS982046V ;  75) ROBOTIC MAJOR , Pack Number CDS982046X ;  76) ROBOTIC MAJOR , Pack Number CDS982046Y ;  77) LIVER PROCEDURE , Pack Number CDS982106J ;  78) ROBOTIC PROCEDURE , Pack Number CDS982128P ;  79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ;  80",
  "description": "FDA recall Z-3046-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) LAVH CDS, Pack Number CDS760049AB;  2) TUBAL LIGATION CDS, Pack Number CDS760053D ;  3) TUBAL LIGATION CDS, Pack Number CDS760053G ;  4) TUBAL LIGATION CDS, Pack Number CDS760053I ;  5) TUBAL LIGATION CDS, Pack Number CDS760053J ;  6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ;  7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ;  8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ;  9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ;  10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ;  11) GYN LAP , Pack Number CDS860087L ;  12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ;  13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ;  14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ;  15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ;  16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ;  17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ;  18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ;  19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ;  20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH;  21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ;  22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ;  23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ;  24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ;  25) LAVH CDS, Pack Number CDS920130J ;  26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ;  27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ;  28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ;  29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ;  30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ;  31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ;  32) GYN LAPAROSCOPIC, Pack Number CDS930224I ;  33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ;  34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ;  35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ;  36) ROBOTIC , Pack Number CDS980523M ;  37) ROBOTIC GYN , Pack Number CDS980647K ;  38) GYN LAP PROCEDURE , Pack Number CDS980810O ;  39) GYN LAP PROCEDURE , Pack Number CDS980810P ;  40) GYN LAP PROCEDURE , Pack Number CDS980810Q ;  41) GYN LAPAROSCOPY , Pack Number CDS980843G ;  42) GYN LAPAROSCOPY , Pack Number CDS980843I ;  43) DAVINCI PROCEDURE , Pack Number CDS980864O ;  44) DAVINCI PROCEDURE , Pack Number CDS980864P ;  45) GYN MAJOR CDS , Pack Number CDS980998J ;  46) GYN MAJOR , Pack Number CDS980998L ;  47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ;  48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ;  49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ;  50) PELVISCOPY CDS, Pack Number CDS981546F ;  51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ;  52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ;  53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ;  54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ;  55) GYN DAVINCI CDS , Pack Number CDS981606F ;  56) ROBOTIC PACK-LF , Pack Number CDS981757Q ;  57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ;  58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ;  59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ;  60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ;  61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ;  62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ;  63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ;  64) ROBOTIC CDS , Pack Number CDS981882W ;  65) ROBOTIC CDS , Pack Number CDS981882X ;  66) LITHOTOMY CDS , Pack Number CDS981897S ;  67) LITHOTOMY CDS , Pack Number CDS981897T ;  68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ;  69) GYN LAPAROSCOPY , Pack Number CDS982032U ;  70) GYN LAPAROSCOPY , Pack Number CDS982032V ;  71) GYN LAPAROSCOPY , Pack Number CDS982032W ;  72) GYN LAPAROSCOPY , Pack Number CDS982032X ;  73) GYN LAPAROSCOPY , Pack Number CDS982032Y ;  74) ROBOTIC , Pack Number CDS982046V ;  75) ROBOTIC MAJOR , Pack Number CDS982046X ;  76) ROBOTIC MAJOR , Pack Number CDS982046Y ;  77) LIVER PROCEDURE , Pack Number CDS982106J ;  78) ROBOTIC PROCEDURE , Pack Number CDS982128P ;  79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ;  80 (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-3046-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) LAVH CDS, Pack Number CDS760049AB;  2) TUBAL LIGATION CDS, Pack Number CDS760053D ;  3) TUBAL LIGATION CDS, Pack Number CDS760053G ;  4) TUBAL LIGATION CDS, Pack Number CDS760053I ;  5) TUBAL LIGATION CDS, Pack Number CDS760053J ;  6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ;  7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ;  8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ;  9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ;  10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ;  11) GYN LAP , Pack Number CDS860087L ;  12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ;  13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ;  14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ;  15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ;  16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ;  17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ;  18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ;  19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ;  20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH;  21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ;  22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ;  23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ;  24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ;  25) LAVH CDS, Pack Number CDS920130J ;  26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ;  27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ;  28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ;  29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ;  30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ;  31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ;  32) GYN LAPAROSCOPIC, Pack Number CDS930224I ;  33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ;  34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ;  35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ;  36) ROBOTIC , Pack Number CDS980523M ;  37) ROBOTIC GYN , Pack Number CDS980647K ;  38) GYN LAP PROCEDURE , Pack Number CDS980810O ;  39) GYN LAP PROCEDURE , Pack Number CDS980810P ;  40) GYN LAP PROCEDURE , Pack Number CDS980810Q ;  41) GYN LAPAROSCOPY , Pack Number CDS980843G ;  42) GYN LAPAROSCOPY , Pack Number CDS980843I ;  43) DAVINCI PROCEDURE , Pack Number CDS980864O ;  44) DAVINCI PROCEDURE , Pack Number CDS980864P ;  45) GYN MAJOR CDS , Pack Number CDS980998J ;  46) GYN MAJOR , Pack Number CDS980998L ;  47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ;  48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ;  49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ;  50) PELVISCOPY CDS, Pack Number CDS981546F ;  51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ;  52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ;  53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ;  54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ;  55) GYN DAVINCI CDS , Pack Number CDS981606F ;  56) ROBOTIC PACK-LF , Pack Number CDS981757Q ;  57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ;  58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ;  59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ;  60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ;  61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ;  62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ;  63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ;  64) ROBOTIC CDS , Pack Number CDS981882W ;  65) ROBOTIC CDS , Pack Number CDS981882X ;  66) LITHOTOMY CDS , Pack Number CDS981897S ;  67) LITHOTOMY CDS , Pack Number CDS981897T ;  68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ;  69) GYN LAPAROSCOPY , Pack Number CDS982032U ;  70) GYN LAPAROSCOPY , Pack Number CDS982032V ;  71) GYN LAPAROSCOPY , Pack Number CDS982032W ;  72) GYN LAPAROSCOPY , Pack Number CDS982032X ;  73) GYN LAPAROSCOPY , Pack Number CDS982032Y ;  74) ROBOTIC , Pack Number CDS982046V ;  75) ROBOTIC MAJOR , Pack Number CDS982046X ;  76) ROBOTIC MAJOR , Pack Number CDS982046Y ;  77) LIVER PROCEDURE , Pack Number CDS982106J ;  78) ROBOTIC PROCEDURE , Pack Number CDS982128P ;  79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ;  80",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3046-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3046-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) LAVH CDS, Pack Number CDS760049AB;  2) TUBAL LIGATION CDS, Pack Number CDS760053D ;  3) TUBAL LIGATION CDS, Pack Number CDS760053G ;  4) TUBAL LIGATION CDS, Pack Number CDS760053I ;  5) TUBAL LIGATION CDS, Pack Number CDS760053J ;  6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ;  7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ;  8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ;  9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ;  10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ;  11) GYN LAP , Pack Number CDS860087L ;  12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ;  13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ;  14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ;  15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ;  16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ;  17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ;  18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ;  19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ;  20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH;  21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ;  22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ;  23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ;  24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ;  25) LAVH CDS, Pack Number CDS920130J ;  26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ;  27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ;  28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ;  29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ;  30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ;  31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ;  32) GYN LAPAROSCOPIC, Pack Number CDS930224I ;  33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ;  34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ;  35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ;  36) ROBOTIC , Pack Number CDS980523M ;  37) ROBOTIC GYN , Pack Number CDS980647K ;  38) GYN LAP PROCEDURE , Pack Number CDS980810O ;  39) GYN LAP PROCEDURE , Pack Number CDS980810P ;  40) GYN LAP PROCEDURE , Pack Number CDS980810Q ;  41) GYN LAPAROSCOPY , Pack Number CDS980843G ;  42) GYN LAPAROSCOPY , Pack Number CDS980843I ;  43) DAVINCI PROCEDURE , Pack Number CDS980864O ;  44) DAVINCI PROCEDURE , Pack Number CDS980864P ;  45) GYN MAJOR CDS , Pack Number CDS980998J ;  46) GYN MAJOR , Pack Number CDS980998L ;  47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ;  48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ;  49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ;  50) PELVISCOPY CDS, Pack Number CDS981546F ;  51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ;  52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ;  53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ;  54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ;  55) GYN DAVINCI CDS , Pack Number CDS981606F ;  56) ROBOTIC PACK-LF , Pack Number CDS981757Q ;  57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ;  58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ;  59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ;  60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ;  61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ;  62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ;  63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ;  64) ROBOTIC CDS , Pack Number CDS981882W ;  65) ROBOTIC CDS , Pack Number CDS981882X ;  66) LITHOTOMY CDS , Pack Number CDS981897S ;  67) LITHOTOMY CDS , Pack Number CDS981897T ;  68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ;  69) GYN LAPAROSCOPY , Pack Number CDS982032U ;  70) GYN LAPAROSCOPY , Pack Number CDS982032V ;  71) GYN LAPAROSCOPY , Pack Number CDS982032W ;  72) GYN LAPAROSCOPY , Pack Number CDS982032X ;  73) GYN LAPAROSCOPY , Pack Number CDS982032Y ;  74) ROBOTIC , Pack Number CDS982046V ;  75) ROBOTIC MAJOR , Pack Number CDS982046X ;  76) ROBOTIC MAJOR , Pack Number CDS982046Y ;  77) LIVER PROCEDURE , Pack Number CDS982106J ;  78) ROBOTIC PROCEDURE , Pack Number CDS982128P ;  79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ;  80",
      "text": "The FDA logged enforcement record Z-3046-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) LAVH CDS, Pack Number CDS760049AB;  2) TUBAL LIGATION CDS, Pack Number CDS760053D ;  3) TUBAL LIGATION CDS, Pack Number CDS760053G ;  4) TUBAL LIGATION CDS, Pack Number CDS760053I ;  5) TUBAL LIGATION CDS, Pack Number CDS760053J ;  6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ;  7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ;  8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ;  9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ;  10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ;  11) GYN LAP , Pack Number CDS860087L ;  12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ;  13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ;  14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ;  15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ;  16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ;  17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ;  18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ;  19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ;  20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH;  21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ;  22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ;  23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ;  24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ;  25) LAVH CDS, Pack Number CDS920130J ;  26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ;  27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ;  28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ;  29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ;  30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ;  31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ;  32) GYN LAPAROSCOPIC, Pack Number CDS930224I ;  33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ;  34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ;  35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ;  36) ROBOTIC , Pack Number CDS980523M ;  37) ROBOTIC GYN , Pack Number CDS980647K ;  38) GYN LAP PROCEDURE , Pack Number CDS980810O ;  39) GYN LAP PROCEDURE , Pack Number CDS980810P ;  40) GYN LAP PROCEDURE , Pack Number CDS980810Q ;  41) GYN LAPAROSCOPY , Pack Number CDS980843G ;  42) GYN LAPAROSCOPY , Pack Number CDS980843I ;  43) DAVINCI PROCEDURE , Pack Number CDS980864O ;  44) DAVINCI PROCEDURE , Pack Number CDS980864P ;  45) GYN MAJOR CDS , Pack Number CDS980998J ;  46) GYN MAJOR , Pack Number CDS980998L ;  47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ;  48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ;  49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ;  50) PELVISCOPY CDS, Pack Number CDS981546F ;  51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ;  52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ;  53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ;  54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ;  55) GYN DAVINCI CDS , Pack Number CDS981606F ;  56) ROBOTIC PACK-LF , Pack Number CDS981757Q ;  57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ;  58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ;  59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ;  60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ;  61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ;  62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ;  63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ;  64) ROBOTIC CDS , Pack Number CDS981882W ;  65) ROBOTIC CDS , Pack Number CDS981882X ;  66) LITHOTOMY CDS , Pack Number CDS981897S ;  67) LITHOTOMY CDS , Pack Number CDS981897T ;  68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ;  69) GYN LAPAROSCOPY , Pack Number CDS982032U ;  70) GYN LAPAROSCOPY , Pack Number CDS982032V ;  71) GYN LAPAROSCOPY , Pack Number CDS982032W ;  72) GYN LAPAROSCOPY , Pack Number CDS982032X ;  73) GYN LAPAROSCOPY , Pack Number CDS982032Y ;  74) ROBOTIC , Pack Number CDS982046V ;  75) ROBOTIC MAJOR , Pack Number CDS982046X ;  76) ROBOTIC MAJOR , Pack Number CDS982046Y ;  77) LIVER PROCEDURE , Pack Number CDS982106J ;  78) ROBOTIC PROCEDURE , Pack Number CDS982128P ;  79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ;  80 — 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: CDS760049AB, Lot Number 19ABQ398 ;  CDS760049AB, Lot Number 19CBC288 ;  CDS760049AB, Lot Number 19DBJ667 ;  CDS760049AB, Lot Number 19FBS065 ;  CDS760049AB, Lot Number 19SBD646 ;  CDS760053D , Lot Number 19HBC984 ;  CDS760053D , Lot Number 19IBL466 ;  CDS760053D , Lot Number 19IBM566 ;  CDS760053D , Lot Number 19VBH599 ;  CDS760053G , Lot Number 20FBV500 ;  CDS760053G , Lot Number 20GBD263 ;  CDS760053G , Lot Number 20IBG285 ;  CDS760053G , Lot Number 20JBL101 ;  CDS760053G , Lot Number 20JBV510 ;  CDS760053G , Lot Number 20LBT279 ;  CDS760053G , Lot Number 21ABS479 ;  CDS760053I , Lot Number 21IBF786 ;  CDS760053I , Lot Number 21IBM006 ;  CDS760053J , Lot Number 21KBM517 ;  CDS760059F , Lot Number 19CBS256 ;  CDS760059F , Lot Number 19DBM571 ;  CDS760059F , Lot Number 19EBN367 ;  CDS760059F , Lot Number 19FBT995 ;  CDS760059F , Lot Number 19HBH102 ;  CDS760059F , Lot Number 19LBQ513 ;  CDS760059F , Lot Number 20CBN847 ;  CDS760059F , Lot Number 20DBJ096 ;  CDS760059G , Lot Number 21GBS677 ;  CDS760059G , Lot Number 20GBB111 ;  CDS760059G , Lot Number 20HBX520 ;  CDS760059G , Lot Number 20WBE693 ;  CDS760059G , Lot Number 21BBE952 ;  CDS760059G , Lot Number 21EBC923 ;  CDS760059I , Lot Number 21KBB608 ;  CDS760059I , Lot Number 21LBB521 ;  CDS760059I , Lot Number 22BBB650 ;  CDS760059I , Lot Number 22CBW321 ;  CDS760059I , Lot Number 22FBN206 ;  CDS760059I , Lot Number 22FBO228 ;  CDS760059I , Lot Number 22GBJ110 ;  CDS760059I , Lot Number 22KBT168 ;  CDS760059I , Lot Number 23ABK519 ;  CDS760059I , Lot Number 23ABM526 ;  CDS760059I , Lot Number 23CBR975 ;  CDS760059I , Lot Number 23EBJ924 ;  CDS760059I , Lot Number 23GBM698 ;  CDS760059I , Lot Number 23IBP654 ;  CDS760059J , Lot Number 23KBR541 ;  CDS760059J , Lot Number 24BBO441 ;  CDS860063R , Lot Number 19BBN586 ;  CDS860063R , Lot Number 19BBN863 ;  CDS860063R , Lot Number 19DBM867 ;  CDS860063R , Lot Number 19EBN792 ;  CDS860063R , Lot Number 19EBZ742 ;  CDS860063R , Lot Number 19FBS583 ;  CDS860087L , Lot Number 20JBM266 ;  CDS860087L , Lot Number 20JBP752 ;  CDS860087L , Lot Number 20KBM008 ;  CDS860087L , Lot Number 20LBH803 ;  CDS860087L , Lot Number 21BBA914 ;  CDS860087L , Lot Number 21CBM984 ;  CDS860119Q , Lot Number 19BBJ567 ;  CDS860119Q , Lot Number 19BBQ131 ;  CDS860119Q , Lot Number 19CBJ502 ;  CDS860119Q , Lot Number 19DBD471 ;  CDS860119Q , Lot Number 19EBC019 ;  CDS860119R , Lot Number 19GBP590 ;  CDS860119S , Lot Number 19JBR629 ;  CDS860119S , Lot Number 19LBQ678 ;  CDS860119S , Lot Number 20CBW864 ;  CDS860119S , Lot Number 20FBF035 ;  CDS860119S , Lot Number 20HBG759 ;  CDS860119S , Lot Number 20IBS603 ;  CDS860119S , Lot Number 20KBH282 ;  CDS860119S , Lot Number 20XBI611 ;  CDS860119S , Lot Number 21BBC179 ;  CDS860119U , Lot Number 21FBL080 ;  CDS860119U , Lot Number 21IBM843 ;  CDS860119U , Lot Number 21JBX733 ;  CDS860119U , Lot Number 22BBY071 ;  CDS860119U , Lot Number 22OBM413 ;  CDS860119U , Lot Number 22FBH802 ;  CDS860119U , Lot Number 22FBY081 ;  CDS860119U , Lot Number 22IBO356 ;  CDS860119U , Lot Number 22IBP080 ;  CDS860119U , Lot Number 22KBF557 ;  CDS860119U , Lot Number 23ABA012 ;  CDS860119U , Lot Number 23ABM771 ;  CDS860119U , Lot Number 23CBE954 ;  CDS860119U , Lot Number 23FBU676 ;  CDS860119U , Lot Number 23HBV063 ;  CDS860119U , Lot Number 23KBD267 ;  CDS860119U , Lot Number 23KBP700 ;  CDS860119U , Lot Number 24BBI127 ;  CDS860119U , Lot Number 21CBO475 ;  CDS860119U , Lot Number 21EBA100 ;  CDS920074X , Lot Number 21HBA528 ;  CDS920074X , Lot Number 21JBH454 ;  CDS920074X , Lot Number 21LBR954 ;  CDS920074X , Lot Number 22ABP698 ;  CDS920074X , Lot Number 22BBF528 ;  CDS920074X , Lot Number 22BBN752 ;  CDS920074X , Lot Number 19CBD372 ;  CDS920074X , Lot Number 22EBN076 ;  CDS920074X , Lot Number 19EBZ739 ;  CDS920074X , Lot Number 22GBJ020 ;  CDS920074X , Lot Number 22GBJ558 ;  CDS920074X , Lot Number 22GBQ814 ;  CDS920074X , Lot Number 19GBS447 ;  CDS920074X , Lot Number 22KBE741 ;  CDS920074X , Lot Number 23BBD060 ;  CDS920074X , Lot Number 23BBG507 ;  CDS920074X , Lot Number 19KBM252 ;  CDS920074X , Lot Number 23CBD877 ;  CDS920074X , Lot Number 19LBQ677 ;  CDS920074X , Lot Number 23EBC471 ;  CDS920074X , Lot Number 20BBH342 ;  CDS920074X , Lot Number 20CBC150 ;  CDS920074X , Lot Number 23GBU814 ;  CDS920074X , Lot Number 20EBF653 ;  CDS920074X , Lot Number 23IBN679 ;  CDS920074X , Lot Number 23JBT302 ;  CDS920074X , Lot Number 20GBF060 ;  CDS920074X , Lot Number 23LBI424 ;  CDS920074X , Lot Number 20HBV919 ;  CDS920074X , Lot Number 23LBS873 ;  CDS920074X , Lot Number 20JBF665 ;  CDS920074X , Lot Number 20JBL124 ;  CDS920074X , Lot Number 20KBJ558 ;  CDS920074X , Lot Number 20XBC454 ;  CDS920074X , Lot Number 21BBI322 ;  CDS920099Q , Lot Number 19CBA005 ;  CDS920099Q , Lot Number 19CBS467 ;  CDS920099Q , Lot Number 19EBH184 ;  CDS920099Q , Lot Number 19EBO250 ;  CDS920099Q , Lot Number 19QBD028 ;  CDS920099Q , Lot Number 19GBS429 ;  CDS920099Q , Lot Number 19JBT795 ;  CDS920099Q , Lot Number 19KBR706 ;  CDS920099Q , Lot Number 20ABQ652 ;  CDS920099Q , Lot Number 20EBS162 ;  CDS920099Q , Lot Number 20HBC293 ;  CDS920099Q , Lot Number 20WBC015 ;  CDS920099Q , Lot Number 21ABQ824 ;  CDS920099Q , Lot Number 21CBD914 ;  CDS920099R , Lot Number 21JBZ840 ;  CDS920099R , Lot Number 21KBX774 ;  CDS920099R , Lot Number 21EBD431 ;  CDS920099S , Lot Number 22EBA153 ;  CDS920099S , Lot Number 22GBP098 ;  CDS920099S , Lot Number 22IBE827 ;  CDS920099S , Lot Number 23ABC459 ;  CDS920099S , Lot Number 23ABE852 ;  CDS920099S , Lot Number 23ABF835 ;  CDS920099S , Lot Number 23GBT006 ;  CDS920099S , Lot Number 23HBS831 ;  CDS920099S , Lot Number 23KBC357 ;  CDS920099S , Lot Number 23LBV707 ;  CDS920099SH, Lot Number 22EBA153 ;  CDS920099SH, Lot Number 22GBP098 ;  CDS920099SH, Lot Number 22IBE827 ;  CDS920099SH, Lot Number 23ABC459 ;  CDS920099SH, Lot Number 23ABE852 ;  CDS920099SH, Lot Number 23ABF835 ;  CDS920099SH, Lot Number 23GBT006 ;  CDS920099SH, Lot Number 23HBS831 ;  CDS920099SH, Lot Number 23KBC357 ;  CDS920099SH, Lot Number 23LBV707 ;  CDS920105D , Lot Number 19BBR799 ;  CDS920105D , Lot Number 19CBT362 ;  CDS920105F , Lot Number 21GBS242 ;  CDS920105F , Lot Number 21JBJ712 ;  CDS920105F , Lot Number 21KBB689 ;  CDS920105F , Lot Number 22ABI243 ;  CDS920105F , Lot Number 19FBW776 ;  CDS920105F , Lot Number 22GBX678 ;  CDS920105F , Lot Number 19HBF314 ;  CDS920105F , Lot Number 22JBH938 ;  CDS920105F , Lot Number 19IBR339 ;  CDS920105F , Lot Number 19JBC612 ;  CDS920105F , Lot Number 20ABU784 ;  CDS920105F , Lot Number 20JBH426 ;  CDS920105F , Lot Number 21BBE893 ;  CDS920105F , Lot Number 21BBG015 ;  CDS920105F , Lot Number 21CBI396 ;  CDS920105F , Lot Number 21CBI815 ;  CDS920105I , Lot Number 23LBO229 ;  CDS920124J , Lot Number 21EME085 ;  CDS920124J , Lot Number 21FMC610 ;  CDS920124J , Lot Number 21GMF550 ;  CDS920124J , Lot Number 22CMB819 ;  CDS920124J , Lot Number 22DME300 ;  CDS920124J , Lot Number 22EMF278 ;  CDS920124J , Lot Number 22HME576 ;  CDS920124J , Lot Number 22HMH620 ;  CDS920124J , Lot Number 22IMD617 ;  CDS920124J , Lot Number 22KMG737 ;  CDS920124J , Lot Number 22LMH598 ;  CDS920124J , Lot Number 23GMH968 ;  CDS920124J , Lot Number 23HMI080 ;  CDS920124J , Lot Number 23IMF066 ;  CDS920124J , Lot Number 24AME652 ;  CDS920124J , Lot Number 19HKB135 ;  CDS920124J , Lot Number 19JKA538 ;  CDS920124J , Lot Number 19LKB632 ;  CDS920124J , Lot Number 20GKA088 ;  CDS920124J , Lot Number 20GKB281 ;  CDS920124J , Lot Number 20HKA339 ;  CDS920124J , Lot Number 20IKA353 ;  CDS920124J , Lot Number 20KKB205 ;  CDS920124J , Lot Number 20LKB219 ;  CDS920124J , Lot Number 21BKA412 ;  CDS920124J , Lot Number 21CKA221 ;  CDS920130J , Lot Number 21HMC146 ;  CDS920130J , Lot Number 21HMD897 ;  CDS920130J , Lot Number 21JMA960 ;  CDS920130J , Lot Number 22EMB969 ;  CDS920130J , Lot Number 22EMH738 ;  CDS920130J , Lot Number 22JMF356 ;  CDS920130J , Lot Number 22LMC714 ;  CDS920130J , Lot Number 19DKA020 ;  CDS920130J , Lot Number 19DKA968 ;  CDS920130J , Lot Number 19EKB184 ;  CDS920130J , Lot Number 19GKA794 ;  CDS920130J , Lot Number 19HKB922 ;  CDS920130J , Lot Number 19JKB113 ;  CDS920130J , Lot Number 19LKA109 ;  CDS920130J , Lot Number 20AKB399 ;  CDS920130J , Lot Number 20BKA490 ;  CDS920130J , Lot Number 20CKA894 ;  CDS930198S , Lot Number 19ABO166 ;  CDS930198S , Lot Number 19CBB270 ;  CDS930198T , Lot Number 19GBM575 ;  CDS930198T , Lot Number 19GBS038 ;  CDS930198T , Lot Number 19HBG585 ;  CDS930198U , Lot Number 21GBN145 ;  CDS930198U , Lot Number 21HBV220 ;  CDS930198U , Lot Number 21IBP939 ;  CDS930198U , Lot Number 19SBE763 ;  CDS930198U , Lot Number 19HBG803 ;  CDS930198U , Lot Number 19UBA584 ;  CDS930198U , Lot Number 19VBG617 ;  CDS930198U , Lot Number 19WBA858 ;  CDS930198U , Lot Number 20ABH023 ;  CDS930198U , Lot Number 20BBK653 ;  CDS930198U , Lot Number 20CBP667 ;  CDS930198U , Lot Number 20EBS253 ;  CDS930198U , Lot Number 20GBR022 ;  CDS930198U , Lot Number 20IBG999 ;  CDS930198U , Lot Number 21ABH875 ;  CDS930198U , Lot Number 21DBP237 ;  CDS930198V , Lot Number 22NBF707 ;  CDS930198V , Lot Number 22CBE776 ;  CDS930198V , Lot Number 22DMB434 ;  CDS930198V , Lot Number 22DMH535 ;  CDS930198W , Lot Number 22FME537 ;  CDS930198X , Lot Number 22FMG585 ;  CDS930198X , Lot Number 22GMA941 ;  CDS930198X , Lot Number 22HMB061 ;  CDS930198X , Lot Number 22JMG032 ;  CDS930198X , Lot Number 22KMF952 ;  CDS930198X , Lot Number 22KMG582 ;  CDS930198X , Lot Number 22LMH721 ;  CDS930224I , Lot Number 21GBF946 ;  CDS930224I , Lot Number 21IBJ244 ;  CDS930224I , Lot Number 21VBB238 ;  CDS930224I , Lot Number 21LBE719 ;  CDS930224I , Lot Number 22ABV308 ;  CDS930224I , Lot Number 19BBD507 ;  CDS930224I , Lot Number 22CBY820 ;  CDS930224I , Lot Number 19CBM450 ;  CDS930224I , Lot Number 22EBK617 ;  CDS930224I , Lot Number 19EBP765 ;  CDS930224I , Lot Number 22FBU431 ;  CDS930224I , Lot Number 19GBB612 ;  CDS930224I , Lot Number 22HBH502 ;  CDS930224I , Lot Number 22IBF740 ;  CDS930224I , Lot Number 19HBW096 ;  CDS930224I , Lot Number 19IBF804 ;  CDS930224I , Lot Number 22KBC726 ;  CDS930224I , Lot Number 22LBG980 ;  CDS930224I , Lot Number 23ABC564 ;  CDS930224I , Lot Number 19KBE823 ;  CDS930224I , Lot Number 23DBF763 ;  CDS930224I , Lot Number 23EBL736 ;  CDS930224I , Lot Number 20BBA099 ;  CDS930224I , Lot Number 23FBK859 ;  CDS930224I , Lot Number 23HBE231 ;  CDS930224I , Lot Number 20GBC048 ;  CDS930224I , Lot Number 20HBI367 ;  CDS930224I , Lot Number 20LBU687 ;  CDS930224I , Lot Number 21BBO952 ;  CDS930224I , Lot Number 21EBC126 ;  CDS930224I , Lot Number 21FBD430 ;  CDS980258S , Lot Number 19CBJ659 ;  CDS980258S , Lot Number 19DBN291 ;  CDS980258S , Lot Number 19FBG007 ;  CDS980258S , Lot Number 19HBK996 ;  CDS980258S , Lot Number 19KBA964 ;  CDS980258S , Lot Number 20ABN385 ;  CDS980258S , Lot Number 20DBD350 ;  CDS980258S , Lot Number 20EBS117 ;  CDS980258T , Lot Number 21FBI700 ;  CDS980258T , Lot Number 21HBE579 ;  CDS980258T , Lot Number 21KBO013 ;  CDS980258T , Lot Number 21LBQ120 ;  CDS980258T , Lot Number 22BBY077 ;  CDS980258T , Lot Number 22BBY079 ; 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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-3046-2024&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-3046-2024&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-3046-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3046-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3046-2024&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-3046-2024&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-3046-2024/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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        "adjudged": false,
        "operative": true
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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          "item": {
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            "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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 CDS920105D , Lot Number 19BBR799 ;  CDS920105D , Lot Number 19CBT362 ;  CDS920105F , Lot Number 21GBS242 ;  CDS920105F , Lot Number 21JBJ712 ;  CDS920105F , Lot Number 21KBB689 ;  CDS920105F , Lot Number 22ABI243 ;  CDS920105F , Lot Number 19FBW776 ;  CDS920105F , Lot Number 22GBX678 ;  CDS920105F , Lot Number 19HBF314 ;  CDS920105F , Lot Number 22JBH938 ;  CDS920105F , Lot Number 19IBR339 ;  CDS920105F , Lot Number 19JBC612 ;  CDS920105F , Lot Number 20ABU784 ;  CDS920105F , Lot Number 20JBH426 ;  CDS920105F , Lot Number 21BBE893 ;  CDS920105F , Lot Number 21BBG015 ;  CDS920105F , Lot Number 21CBI396 ;  CDS920105F , Lot Number 21CBI815 ;  CDS920105I , Lot Number 23LBO229 ;  CDS920124J , Lot Number 21EME085 ;  CDS920124J , Lot Number 21FMC610 ;  CDS920124J , Lot Number 21GMF550 ;  CDS920124J , Lot Number 22CMB819 ;  CDS920124J , Lot Number 22DME300 ;  CDS920124J , Lot Number 22EMF278 ;  CDS920124J , Lot Number 22HME576 ;  CDS920124J , Lot Number 22HMH620 ;  CDS920124J , Lot Number 22IMD617 ; 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 CDS982046Y , Lot Number 23LBQ700 ;  CDS982106J , Lot Number 19BLA549 ;  CDS982128P , Lot Number 23IBP272 ;  CDS982128P , Lot Number 23JBH258 ;  CDS982128P , Lot Number 23JBP789 ;  CDS982128P , Lot Number 23JBV057 ;  CDS982128P , Lot Number 23KBX238 ;  CDS982245K , Lot Number 21IBG401 ;  CDS982245K , Lot Number 19BBO450 ;  CDS982245K , Lot Number 19EBA751 ;  CDS982245K , Lot Number 19FBH182 ;  CDS982245K , Lot Number 19SBA844 ;  CDS982245K , Lot Number 19HBB359 ;  CDS982245K , Lot Number 19IBC891 ;  CDS982245K , Lot Number 19WBB686 ;  CDS982245K , Lot Number 19LBA098 ;  CDS982245K , Lot Number 20ABI380 ;  CDS982245K , Lot Number 20CBA330 ;  CDS982245K , Lot Number 20DBD324 ;  CDS982245K , Lot Number 20GBB070 ;  CDS982245K , Lot Number 20GBF875 ;  CDS982245K , Lot Number 20JBG037 ;  CDS982245K , Lot Number 20JBL114 ;  CDS982245K , Lot Number 20KBA320 ;  CDS982245K , Lot Number 20WBF664 ;  CDS982245K , Lot Number 21CBV967 ;  CDS982245K , Lot Number 21DBT242 ;  CDS982245K , Lot Number 21EBK792 ;  CDS982245K , Lot Number 21EBR788 ;  CDS982245L , Lot Number 21JBP592 ;  CDS982245L , Lot Number 22ABF479 ;  CDS982245L , Lot Number 22ABH941 ;  CDS982245L , Lot Number 22CBL561 ;  CDS982245L , Lot Number 22CBX888 ;  CDS982245L , Lot Number 22OBE752 ;  CDS982245L , Lot Number 22EBN207 ;  CDS982245L , Lot Number 22FBR888 ;  CDS982245L , Lot Number 22GBF357 ;  CDS982245L , Lot Number 22IBB520 ;  CDS982245L , Lot Number 22KBJ794 ;  CDS982245L , Lot Number 22LBF250 ;  CDS982245L , Lot Number 23ABT181 ;  CDS982245L , Lot Number 23BBB697 ;  CDS982245L , Lot Number 23CBJ972 ;  CDS982245L , Lot Number 23CBV030 ;  CDS982245L , Lot Number 23EBD368 ;  CDS982273P , Lot Number 19SBD292 ;  CDS982273P , Lot Number 19LBK602 ;  CDS982273P , Lot Number 20BBD356 ;  CDS982273P , Lot Number 20EBS071 ;  CDS982273P , Lot Number 20FBI355 ;  CDS982273P , Lot Number 20HBJ892 ;  CDS982273P , Lot Number 21ABU052 ;  CDS982273P , Lot Number 21CBM463 ;  CDS982273P , Lot Number 21EBD103 ;  CDS982284M , Lot Number 21GMA031 ;  CDS982284M , Lot Number 21HMB423 ;  CDS982284M , Lot Number 21JMB056 ;  CDS982284M , Lot Number 21KMB049 ;  CDS982284M , Lot Number 21LMA964 ;  CDS982284M , Lot Number 22CMH034 ;  CDS982284M , Lot Number 22DMH537 ;  CDS982284M , Lot Number 22EMF286 ;  CDS982284M , Lot Number 22GMD547 ;  CDS982284M , Lot Number 22KME514 ;  CDS982284M , Lot Number 23AMB708 ;  CDS982284M , Lot Number 23BMB977 ;  CDS982284M , Lot Number 23CME819 ;  CDS982284M , Lot Number 23FMD784 ;  CDS982284M , Lot Number 23GME982 ;  CDS982284M , Lot Number 23GMI475 ;  CDS982284M , Lot Number 19EKB231 ;  CDS982284M , Lot Number 19GKA637 ;  CDS982284M , Lot Number 19HKD128 ;  CDS982284M , Lot Number 19KKA961 ;  CDS982284M , Lot Number 20AKA926 ;  CDS982284M , Lot Number 20BKB105 ;  CDS982284M , Lot Number 20JKA188 ;  CDS982284M , Lot Number 20LKA595 ;  CDS982284M , Lot Number 20LKB222 ;  CDS982284N , Lot Number 23IMB940 ;  CDS982284N , Lot Number 23IMD670 ;  CDS982284N , Lot Number 24AMD074 ;  CDS982295D , Lot Number 19CBJ645 ;  CDS982295D , Lot Number 19EBI215 ;  CDS982295D , Lot Number 19FBL870 ;  CDS982407O , Lot Number 21KBX749 ;  CDS982407O , Lot Number 21LBO660 ;  CDS982407O , Lot Number 22BBU815 ;  CDS982407P , Lot Number 22DBJ061 ;  CDS982407P , Lot Number 22FBU838 ;  CDS982407P , Lot Number 22HBW089 ;  CDS982407P , Lot Number 22JBD293 ;  CDS982407P , Lot Number 22LBC410 ;  CDS982407P , Lot Number 23ABA808 ;  CDS982407P , Lot Number 23BBJ995 ;  CDS982407P , Lot Number 23EBE997 ;  CDS982407P , Lot Number 23GBL921 ;  CDS982407P , Lot Number 23GBO574 ;  CDS982407P , Lot Number 23IBC607 ;  CDS982407P , Lot Number 23JBQ095 ;  CDS982407P , Lot Number 24BBP684 ;  CDS982407P , Lot Number 23GBO574Z;  CDS982409B , Lot Number 21FBI692 ;  CDS982409B , Lot Number 21HBF497 ;  CDS982409B , Lot Number 21JBD216 ;  CDS982409B , Lot Number 21KBV871 ;  CDS982409B , Lot Number 22CBD908 ;  CDS982409B , Lot Number 19BBN118 ;  CDS982409B , Lot Number 19CBH599 ;  CDS982409B , Lot Number 22DBS500 ;  CDS982409B , Lot Number 19EBK186 ;  CDS982409B , Lot Number 22GBF547 ;  CDS982409B , Lot Number 19GBO671 ;  CDS982409B , Lot Number 22IBF601 ;  CDS982409B , Lot Number 22JBB909 ;  CDS982409B , Lot Number 19IBD012 ;  CDS982409B , Lot Number 22KBN942 ;  CDS982409B , Lot Number 19JBZ634 ;  CDS982409B , Lot Number 23BBU074 ;  CDS982409B , Lot Number 19LBG155 ;  CDS982409B , Lot Number 23CBU290 ;  CDS982409B , Lot Number 20ABR783 ;  CDS982409B , Lot Number 23EBT905 ;  CDS982409B , Lot Number 20CBW979 ;  CDS982409B , Lot Number 23GBV747 ;  CDS982409B , Lot Number 23HBU564 ;  CDS982409B , Lot Number 20EBI819 ;  CDS982409B , Lot Number 20FBW336 ;  CDS982409B , Lot Number 23JBS906 ;  CDS982409B , Lot Number 23LBJ470 ;  CDS982409B , Lot Number 20IBD964 ;  CDS982409B , Lot Number 24BBI062 ;  CDS982409B , Lot Number 20LBF051 ;  CDS982409B , Lot Number 21ABS082 ;  CDS982409B , Lot Number 21DBG121 ;  CDS982488K , Lot Number 19BDA592 ;  CDS982488K , Lot Number 19CDD202 ;  CDS982488K , Lot Number 19EDB205 ;  CDS982488K , Lot Number 19GDA248 ;  CDS982488K , Lot Number 19IDB186 ;  CDS982488K , Lot Number 19IDB558 ;  CDS982488K , Lot Number 19KDC371 ;  CDS982488K , Lot Number 20BDA894 ;  CDS982591K , Lot Number 21LMA320 ;  CDS982606I , Lot Number 21KMH201 ;  CDS982607K , Lot Number 21KMG877 ;  CDS982662M , Lot Number 19BBN663 ;  CDS982662M , Lot Number 19DBJ801 ;  CDS982662N , Lot Number 19QBA183 ;  CDS982662N , Lot Number 19GBO321 ;  CDS982662N , Lot Number 19HBA532 ;  CDS982662O , Lot Number 19JBE326 ;  CDS982662O , Lot Number 19KBF420 ;  CDS982662O , Lot Number 19KBT842 ;  CDS982662O , Lot Number 19LBV462 ;  CDS982662O , Lot Number 20CBV696 ;  CDS982662O , Lot Number 20CBY267 ;  CDS982662O , Lot Number 20DBU554 ;  CDS982662O , Lot Number 20FBU283 ;  CDS982662O , Lot Number 20GBU942 ;  CDS982662O , Lot Number 20HBU664 ;  CDS982662O , Lot Number 20IBS595 ;  CDS982662O , Lot Number 20JBO712 ;  CDS982662O , Lot Number 20KBR862 ;  CDS982662O , Lot Number 21ABP688 ;  CDS982662O , Lot Number 21ABW355 ;  CDS982679L , Lot Number 21FME047 ;  CDS982679L , Lot Number 21IMA034 ;  CDS982679L , Lot Number 21LME776 ;  CDS982679L , Lot Number 19AKA700 ;  CDS982679L , Lot Number 19CKA534 ;  CDS982679L , Lot Number 19EKC220 ;  CDS982679L , Lot Number 19HKA043 ;  CDS982679L , Lot Number 19IKA718 ;  CDS982679L , Lot Number 19IKA890 ;  CDS982679L , Lot Number 19JKB869 ;  CDS982679L , Lot Number 20AKB226 ;  CDS982679L , Lot Number 20CKA734 ;  CDS982679L , Lot Number 20IKB337 ;  CDS982679L , Lot Number 20LKA128 ;  CDS982679L , Lot Number 21DKA075 ;  CDS982725L , Lot Number 19IBS888 ;  CDS982725L , Lot Number 19LBN315 ;  CDS982725L , Lot Number 20BBN575 ;  CDS982725L , Lot Number 20OBA201 ;  CDS982725L , Lot Number 20DBP910 ;  CDS982725L , Lot Number 20FBC059 ;  CDS982725L , Lot Number 20GBB099 ;  CDS982725L , Lot Number 20IBQ467 ;  CDS982725O , Lot Number 22JBR891 ;  CDS982725O , Lot Number 22KBC304 ;  CDS982725O , Lot Number 22KBT277 ;  CDS982725O , Lot Number 23CBJ502 ;  CDS982725O , Lot Number 23CBX465 ;  CDS982725O , Lot Number 23DBM973 ;  CDS982725O , Lot Number 23GBL984 ;  CDS982725O , Lot Number 23KBF949 ;  CDS982725O , Lot Number 23KBW247 ;  CDS982725O , Lot Number 24BBL544 ;  CDS982727J , Lot Number 21FBL935 ;  CDS982727J , Lot Number 21HBT610 ;  CDS982727J , Lot Number 21IBM955 ;  CDS982727J , Lot Number 21KBG314 ;  CDS982727J , Lot Number 22BBH036 ;  CDS982727J , Lot Number 22DBN463 ;  CDS982727J , Lot Number 21DBO223 ;  CDS982727J , Lot Number 21DBU891 ;  CDS982727K , Lot Number 22FBG590 ;  CDS982727K , Lot Number 22GBV038 ;  CDS982727K , Lot Number 22HBT918 ;  CDS982727L , Lot Number 22KBR933 ;  CDS982727L , Lot Number 23ABI378 ;  CDS982727L , Lot Number 23BBM211 ;  CDS982727L , Lot Number 23CBO776 ;  CDS982727L , Lot Number 23DBF746 ;  CDS982727L , Lot Number 23DBQ561 ;  CDS982727L , Lot Number 23FBB707 ;  CDS982727L , Lot Number 23FBP579 ;  CDS982727L , Lot Number 23IBU402 ;  CDS982727L , Lot Number 23JBU722 ;  CDS982727L , Lot Number 23KBL302 ;  CDS982727L , Lot Number 24BBC548 ;  CDS982731O , Lot Number 22BMF647 ;  CDS982731O , Lot Number 22DMB456 ;  CDS982731O , Lot Number 22FMD337 ;  CDS982731O , Lot Number 22HMA004 ;  CDS982731O , Lot Number 23AMB748 ;  CDS982731O , Lot Number 23BMI326 ;  CDS982731O , Lot Number 23CMG432 ;  CDS982731O , Lot Number 23GMA378 ;  CDS982731O , Lot Number 23HME853 ;  CDS982731O , Lot Number 23JMI275 ;  CDS982731O , Lot Number 23LMB991 ;  CDS982731O , Lot Number 24AME925 ;  CDS982732K , Lot Number 19BKD747 ;  CDS982732K , Lot Number 19EKA119 ;  CDS982732L , Lot Number 21KMB553 ;  CDS982732L , Lot Number 21KMH399 ;  CDS982732L , Lot Number 21LMG806 ;  CDS982748D , Lot Number 19ABQ272 ;  CDS982748D , Lot Number 19BBN162 ;  CDS982748D , Lot Number 19DBN531 ;  CDS982748D , Lot Number 19EBI584 ;  CDS982748D , Lot Number 19FBD106 ;  CDS982748F , Lot Number 19GBD577 ;  CDS982748G , Lot Number 19HBP057 ;  CDS982748G , Lot Number 19IBD260 ;  CDS982748G , Lot Number 19LBW332 ;  CDS982780Q , Lot Number 19PBC856 ;  CDS982780Q , Lot Number 19GBW299 ;  CDS982780R , Lot Number 19HBW385 ;  CDS982780R , Lot Number 19IBC640 ;  CDS982780R , Lot Number 19KBA649 ;  CDS982780R , Lot Number 19KBB917 ;  CDS982780R , Lot Number 20ABH028 ;  CDS982780R , Lot Number 20OBA202 ;  CDS982780R , Lot Number 20DBO903 ;  CDS982780R , Lot Number 20EBC262 ;  CDS982780R , Lot Number 20EBI785 ;  CDS982780R , Lot Number 20EBV319 ;  CDS982780R , Lot Num",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}