{
  "@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-1444-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline procedure kits labeled as:   1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D;  2) ABD CLOSURE PACK, Pack Number DYNJ56987B;  3) ADULT PERC PACK-LF, Pack Number PHS170994005A;  4) BASIC PACK, Pack Number DYNJ54836B;  5) BASIC PACK, Pack Number DYNJ58678A;  6) BASIC PACK, Pack Number DYNJ63532;  7) BASIC PACK, Pack Number DYNJ81702;  8) BASIC PACK, Pack Number DYNJ36595D;  9) BASIC PACK, Pack Number DYNJ69250A;  10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C;  11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A;  12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A;  13) CABG PACK, Pack Number DYNJ20114Q;  14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L;  15) CHEST PACK SC-LF, Pack Number DYNJ38051F;  16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B;  17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B;  18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C;  19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B;  20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385;  21) CT BASIC PACK, Pack Number DYNJ51617A;  22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I;  23) CYSTO, Pack Number DYNJ24351D;  24) CYSTO PACK, Pack Number DYNJ62359A;  25) DAVINCI PACK, Pack Number DYNJ04113C;  26) DUPYTRENS PACK, Pack Number DYNJ60496;  27) EH PACEMAKER PACK, Pack Number DYNJ55734C;  28) EVLT PACK, Pack Number DYNJ45997C;  29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G;  30) GENERAL BASIC PACK, Pack Number DYNJ82039;  31) GENERAL PURPOSE CV, Pack Number DYNJ904395F;  32) GENERAL UTILITY PACK, Pack Number DYNJ45093B;  33) HP DEVICE-LF, Pack Number DYNJ62255A;  34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B;  35) IR PACK, Pack Number DYNJ32080L;  36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857;  37) IR TABLE PACK II, Pack Number DYNJ56298B;  38) JVL-PACK TUNNELED, Pack Number DYNJ66065;  39) LITHOTOMY PACK, Pack Number DYNJ66490B;  40) LITHOTOMY PACK, Pack Number DYNJ65380A;  41) LOOP RECORDER PACK, Pack Number DYNJ53221B;  42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A;  43) MAJOR BASIN PACK, Pack Number DYNJ67484A;  44) MAJOR PACK, Pack Number DYNJ51996;  45) MAJOR PACK-LF, Pack Number DYNJ24599I;  46) MINI PACK, Pack Number DYNJ52305D;  47) MINI SET UP KIT, Pack Number DYNJ81562;  48) MINOR BASIN, Pack Number DYNJ43021B;  49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286;  50) MINOR PACK-LF, Pack Number DYNJ0551383P;  51) MINOR PK-LF, Pack Number DYNJ21408D;  52) MINOR WAKEFIELD, Pack Number DYNJ58872A;  53) MYELOGRAM TRAY, Pack Number DYNDH1775A;  54) OB PACK, Pack Number DYNJ32216B;  55) OPEN STERILE PACK, Pack Number DYNJ62104A;  56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B;  57) PACK URO-BASIC, Pack Number DYNJ38246A;  58) PACK,LTD BODY SSP, Pack Number DYNJ65488B;  59) PARACENTESIS, Pack Number DYNJ44505B;  60) PBMS NECK PACK-LF, Pack Number DYNJ64961A;  61) PEDI MAJOR PACK, Pack Number DYNJ40062K;  62) PEDI PK-LF, Pack Number DYNJ21240J;  63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B;  64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B;  65) PK, GEN-MINOR, Pack Number DYNJ59461C;  66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B;  67) PK, URO-CYSTO-MH, Pack Number DYNJ62501;  68) PK-GEN-BASIC, Pack Number DYNJ42382B;  69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B;  70) PODIATRY PACK, Pack Number DYNJ37297D;  71) PST PACK, Pack Number DYNJ62666;  72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J;  73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A;  74) SHUNT PACK-LF, Pack Number PHS967363W;  75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242;  76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X;  77) STANDARD ICL PACK-LF, Pack Number PHS895675B;  78) T & A PK-LF, Pack Number DYNJT2408C;  79) THORACIC PACK SHD, Pack Number DYNJ68416C;  80) TONSIL PACK-LF, Pack Number DYNJ0553334I;  81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I;  82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M;  83) VASECTOMY PACK, Pack Number DYNJ65326;  84) VASECTOMY PACK,",
  "description": "FDA recall Z-1444-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as:   1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D;  2) ABD CLOSURE PACK, Pack Number DYNJ56987B;  3) ADULT PERC PACK-LF, Pack Number PHS170994005A;  4) BASIC PACK, Pack Number DYNJ54836B;  5) BASIC PACK, Pack Number DYNJ58678A;  6) BASIC PACK, Pack Number DYNJ63532;  7) BASIC PACK, Pack Number DYNJ81702;  8) BASIC PACK, Pack Number DYNJ36595D;  9) BASIC PACK, Pack Number DYNJ69250A;  10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C;  11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A;  12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A;  13) CABG PACK, Pack Number DYNJ20114Q;  14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L;  15) CHEST PACK SC-LF, Pack Number DYNJ38051F;  16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B;  17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B;  18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C;  19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B;  20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385;  21) CT BASIC PACK, Pack Number DYNJ51617A;  22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I;  23) CYSTO, Pack Number DYNJ24351D;  24) CYSTO PACK, Pack Number DYNJ62359A;  25) DAVINCI PACK, Pack Number DYNJ04113C;  26) DUPYTRENS PACK, Pack Number DYNJ60496;  27) EH PACEMAKER PACK, Pack Number DYNJ55734C;  28) EVLT PACK, Pack Number DYNJ45997C;  29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G;  30) GENERAL BASIC PACK, Pack Number DYNJ82039;  31) GENERAL PURPOSE CV, Pack Number DYNJ904395F;  32) GENERAL UTILITY PACK, Pack Number DYNJ45093B;  33) HP DEVICE-LF, Pack Number DYNJ62255A;  34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B;  35) IR PACK, Pack Number DYNJ32080L;  36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857;  37) IR TABLE PACK II, Pack Number DYNJ56298B;  38) JVL-PACK TUNNELED, Pack Number DYNJ66065;  39) LITHOTOMY PACK, Pack Number DYNJ66490B;  40) LITHOTOMY PACK, Pack Number DYNJ65380A;  41) LOOP RECORDER PACK, Pack Number DYNJ53221B;  42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A;  43) MAJOR BASIN PACK, Pack Number DYNJ67484A;  44) MAJOR PACK, Pack Number DYNJ51996;  45) MAJOR PACK-LF, Pack Number DYNJ24599I;  46) MINI PACK, Pack Number DYNJ52305D;  47) MINI SET UP KIT, Pack Number DYNJ81562;  48) MINOR BASIN, Pack Number DYNJ43021B;  49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286;  50) MINOR PACK-LF, Pack Number DYNJ0551383P;  51) MINOR PK-LF, Pack Number DYNJ21408D;  52) MINOR WAKEFIELD, Pack Number DYNJ58872A;  53) MYELOGRAM TRAY, Pack Number DYNDH1775A;  54) OB PACK, Pack Number DYNJ32216B;  55) OPEN STERILE PACK, Pack Number DYNJ62104A;  56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B;  57) PACK URO-BASIC, Pack Number DYNJ38246A;  58) PACK,LTD BODY SSP, Pack Number DYNJ65488B;  59) PARACENTESIS, Pack Number DYNJ44505B;  60) PBMS NECK PACK-LF, Pack Number DYNJ64961A;  61) PEDI MAJOR PACK, Pack Number DYNJ40062K;  62) PEDI PK-LF, Pack Number DYNJ21240J;  63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B;  64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B;  65) PK, GEN-MINOR, Pack Number DYNJ59461C;  66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B;  67) PK, URO-CYSTO-MH, Pack Number DYNJ62501;  68) PK-GEN-BASIC, Pack Number DYNJ42382B;  69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B;  70) PODIATRY PACK, Pack Number DYNJ37297D;  71) PST PACK, Pack Number DYNJ62666;  72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J;  73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A;  74) SHUNT PACK-LF, Pack Number PHS967363W;  75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242;  76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X;  77) STANDARD ICL PACK-LF, Pack Number PHS895675B;  78) T & A PK-LF, Pack Number DYNJT2408C;  79) THORACIC PACK SHD, Pack Number DYNJ68416C;  80) TONSIL PACK-LF, Pack Number DYNJ0553334I;  81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I;  82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M;  83) VASECTOMY PACK, Pack Number DYNJ65326;  84) VASECTOMY PACK, (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1444-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline procedure kits labeled as:   1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D;  2) ABD CLOSURE PACK, Pack Number DYNJ56987B;  3) ADULT PERC PACK-LF, Pack Number PHS170994005A;  4) BASIC PACK, Pack Number DYNJ54836B;  5) BASIC PACK, Pack Number DYNJ58678A;  6) BASIC PACK, Pack Number DYNJ63532;  7) BASIC PACK, Pack Number DYNJ81702;  8) BASIC PACK, Pack Number DYNJ36595D;  9) BASIC PACK, Pack Number DYNJ69250A;  10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C;  11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A;  12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A;  13) CABG PACK, Pack Number DYNJ20114Q;  14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L;  15) CHEST PACK SC-LF, Pack Number DYNJ38051F;  16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B;  17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B;  18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C;  19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B;  20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385;  21) CT BASIC PACK, Pack Number DYNJ51617A;  22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I;  23) CYSTO, Pack Number DYNJ24351D;  24) CYSTO PACK, Pack Number DYNJ62359A;  25) DAVINCI PACK, Pack Number DYNJ04113C;  26) DUPYTRENS PACK, Pack Number DYNJ60496;  27) EH PACEMAKER PACK, Pack Number DYNJ55734C;  28) EVLT PACK, Pack Number DYNJ45997C;  29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G;  30) GENERAL BASIC PACK, Pack Number DYNJ82039;  31) GENERAL PURPOSE CV, Pack Number DYNJ904395F;  32) GENERAL UTILITY PACK, Pack Number DYNJ45093B;  33) HP DEVICE-LF, Pack Number DYNJ62255A;  34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B;  35) IR PACK, Pack Number DYNJ32080L;  36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857;  37) IR TABLE PACK II, Pack Number DYNJ56298B;  38) JVL-PACK TUNNELED, Pack Number DYNJ66065;  39) LITHOTOMY PACK, Pack Number DYNJ66490B;  40) LITHOTOMY PACK, Pack Number DYNJ65380A;  41) LOOP RECORDER PACK, Pack Number DYNJ53221B;  42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A;  43) MAJOR BASIN PACK, Pack Number DYNJ67484A;  44) MAJOR PACK, Pack Number DYNJ51996;  45) MAJOR PACK-LF, Pack Number DYNJ24599I;  46) MINI PACK, Pack Number DYNJ52305D;  47) MINI SET UP KIT, Pack Number DYNJ81562;  48) MINOR BASIN, Pack Number DYNJ43021B;  49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286;  50) MINOR PACK-LF, Pack Number DYNJ0551383P;  51) MINOR PK-LF, Pack Number DYNJ21408D;  52) MINOR WAKEFIELD, Pack Number DYNJ58872A;  53) MYELOGRAM TRAY, Pack Number DYNDH1775A;  54) OB PACK, Pack Number DYNJ32216B;  55) OPEN STERILE PACK, Pack Number DYNJ62104A;  56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B;  57) PACK URO-BASIC, Pack Number DYNJ38246A;  58) PACK,LTD BODY SSP, Pack Number DYNJ65488B;  59) PARACENTESIS, Pack Number DYNJ44505B;  60) PBMS NECK PACK-LF, Pack Number DYNJ64961A;  61) PEDI MAJOR PACK, Pack Number DYNJ40062K;  62) PEDI PK-LF, Pack Number DYNJ21240J;  63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B;  64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B;  65) PK, GEN-MINOR, Pack Number DYNJ59461C;  66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B;  67) PK, URO-CYSTO-MH, Pack Number DYNJ62501;  68) PK-GEN-BASIC, Pack Number DYNJ42382B;  69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B;  70) PODIATRY PACK, Pack Number DYNJ37297D;  71) PST PACK, Pack Number DYNJ62666;  72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J;  73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A;  74) SHUNT PACK-LF, Pack Number PHS967363W;  75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242;  76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X;  77) STANDARD ICL PACK-LF, Pack Number PHS895675B;  78) T & A PK-LF, Pack Number DYNJT2408C;  79) THORACIC PACK SHD, Pack Number DYNJ68416C;  80) TONSIL PACK-LF, Pack Number DYNJ0553334I;  81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I;  82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M;  83) VASECTOMY PACK, Pack Number DYNJ65326;  84) VASECTOMY PACK,",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1444-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1444-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as:   1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D;  2) ABD CLOSURE PACK, Pack Number DYNJ56987B;  3) ADULT PERC PACK-LF, Pack Number PHS170994005A;  4) BASIC PACK, Pack Number DYNJ54836B;  5) BASIC PACK, Pack Number DYNJ58678A;  6) BASIC PACK, Pack Number DYNJ63532;  7) BASIC PACK, Pack Number DYNJ81702;  8) BASIC PACK, Pack Number DYNJ36595D;  9) BASIC PACK, Pack Number DYNJ69250A;  10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C;  11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A;  12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A;  13) CABG PACK, Pack Number DYNJ20114Q;  14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L;  15) CHEST PACK SC-LF, Pack Number DYNJ38051F;  16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B;  17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B;  18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C;  19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B;  20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385;  21) CT BASIC PACK, Pack Number DYNJ51617A;  22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I;  23) CYSTO, Pack Number DYNJ24351D;  24) CYSTO PACK, Pack Number DYNJ62359A;  25) DAVINCI PACK, Pack Number DYNJ04113C;  26) DUPYTRENS PACK, Pack Number DYNJ60496;  27) EH PACEMAKER PACK, Pack Number DYNJ55734C;  28) EVLT PACK, Pack Number DYNJ45997C;  29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G;  30) GENERAL BASIC PACK, Pack Number DYNJ82039;  31) GENERAL PURPOSE CV, Pack Number DYNJ904395F;  32) GENERAL UTILITY PACK, Pack Number DYNJ45093B;  33) HP DEVICE-LF, Pack Number DYNJ62255A;  34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B;  35) IR PACK, Pack Number DYNJ32080L;  36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857;  37) IR TABLE PACK II, Pack Number DYNJ56298B;  38) JVL-PACK TUNNELED, Pack Number DYNJ66065;  39) LITHOTOMY PACK, Pack Number DYNJ66490B;  40) LITHOTOMY PACK, Pack Number DYNJ65380A;  41) LOOP RECORDER PACK, Pack Number DYNJ53221B;  42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A;  43) MAJOR BASIN PACK, Pack Number DYNJ67484A;  44) MAJOR PACK, Pack Number DYNJ51996;  45) MAJOR PACK-LF, Pack Number DYNJ24599I;  46) MINI PACK, Pack Number DYNJ52305D;  47) MINI SET UP KIT, Pack Number DYNJ81562;  48) MINOR BASIN, Pack Number DYNJ43021B;  49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286;  50) MINOR PACK-LF, Pack Number DYNJ0551383P;  51) MINOR PK-LF, Pack Number DYNJ21408D;  52) MINOR WAKEFIELD, Pack Number DYNJ58872A;  53) MYELOGRAM TRAY, Pack Number DYNDH1775A;  54) OB PACK, Pack Number DYNJ32216B;  55) OPEN STERILE PACK, Pack Number DYNJ62104A;  56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B;  57) PACK URO-BASIC, Pack Number DYNJ38246A;  58) PACK,LTD BODY SSP, Pack Number DYNJ65488B;  59) PARACENTESIS, Pack Number DYNJ44505B;  60) PBMS NECK PACK-LF, Pack Number DYNJ64961A;  61) PEDI MAJOR PACK, Pack Number DYNJ40062K;  62) PEDI PK-LF, Pack Number DYNJ21240J;  63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B;  64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B;  65) PK, GEN-MINOR, Pack Number DYNJ59461C;  66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B;  67) PK, URO-CYSTO-MH, Pack Number DYNJ62501;  68) PK-GEN-BASIC, Pack Number DYNJ42382B;  69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B;  70) PODIATRY PACK, Pack Number DYNJ37297D;  71) PST PACK, Pack Number DYNJ62666;  72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J;  73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A;  74) SHUNT PACK-LF, Pack Number PHS967363W;  75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242;  76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X;  77) STANDARD ICL PACK-LF, Pack Number PHS895675B;  78) T & A PK-LF, Pack Number DYNJT2408C;  79) THORACIC PACK SHD, Pack Number DYNJ68416C;  80) TONSIL PACK-LF, Pack Number DYNJ0553334I;  81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I;  82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M;  83) VASECTOMY PACK, Pack Number DYNJ65326;  84) VASECTOMY PACK,",
      "text": "The FDA logged enforcement record Z-1444-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline procedure kits labeled as:   1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D;  2) ABD CLOSURE PACK, Pack Number DYNJ56987B;  3) ADULT PERC PACK-LF, Pack Number PHS170994005A;  4) BASIC PACK, Pack Number DYNJ54836B;  5) BASIC PACK, Pack Number DYNJ58678A;  6) BASIC PACK, Pack Number DYNJ63532;  7) BASIC PACK, Pack Number DYNJ81702;  8) BASIC PACK, Pack Number DYNJ36595D;  9) BASIC PACK, Pack Number DYNJ69250A;  10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C;  11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A;  12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A;  13) CABG PACK, Pack Number DYNJ20114Q;  14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L;  15) CHEST PACK SC-LF, Pack Number DYNJ38051F;  16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B;  17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B;  18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C;  19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B;  20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385;  21) CT BASIC PACK, Pack Number DYNJ51617A;  22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I;  23) CYSTO, Pack Number DYNJ24351D;  24) CYSTO PACK, Pack Number DYNJ62359A;  25) DAVINCI PACK, Pack Number DYNJ04113C;  26) DUPYTRENS PACK, Pack Number DYNJ60496;  27) EH PACEMAKER PACK, Pack Number DYNJ55734C;  28) EVLT PACK, Pack Number DYNJ45997C;  29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G;  30) GENERAL BASIC PACK, Pack Number DYNJ82039;  31) GENERAL PURPOSE CV, Pack Number DYNJ904395F;  32) GENERAL UTILITY PACK, Pack Number DYNJ45093B;  33) HP DEVICE-LF, Pack Number DYNJ62255A;  34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B;  35) IR PACK, Pack Number DYNJ32080L;  36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857;  37) IR TABLE PACK II, Pack Number DYNJ56298B;  38) JVL-PACK TUNNELED, Pack Number DYNJ66065;  39) LITHOTOMY PACK, Pack Number DYNJ66490B;  40) LITHOTOMY PACK, Pack Number DYNJ65380A;  41) LOOP RECORDER PACK, Pack Number DYNJ53221B;  42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A;  43) MAJOR BASIN PACK, Pack Number DYNJ67484A;  44) MAJOR PACK, Pack Number DYNJ51996;  45) MAJOR PACK-LF, Pack Number DYNJ24599I;  46) MINI PACK, Pack Number DYNJ52305D;  47) MINI SET UP KIT, Pack Number DYNJ81562;  48) MINOR BASIN, Pack Number DYNJ43021B;  49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286;  50) MINOR PACK-LF, Pack Number DYNJ0551383P;  51) MINOR PK-LF, Pack Number DYNJ21408D;  52) MINOR WAKEFIELD, Pack Number DYNJ58872A;  53) MYELOGRAM TRAY, Pack Number DYNDH1775A;  54) OB PACK, Pack Number DYNJ32216B;  55) OPEN STERILE PACK, Pack Number DYNJ62104A;  56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B;  57) PACK URO-BASIC, Pack Number DYNJ38246A;  58) PACK,LTD BODY SSP, Pack Number DYNJ65488B;  59) PARACENTESIS, Pack Number DYNJ44505B;  60) PBMS NECK PACK-LF, Pack Number DYNJ64961A;  61) PEDI MAJOR PACK, Pack Number DYNJ40062K;  62) PEDI PK-LF, Pack Number DYNJ21240J;  63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B;  64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B;  65) PK, GEN-MINOR, Pack Number DYNJ59461C;  66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B;  67) PK, URO-CYSTO-MH, Pack Number DYNJ62501;  68) PK-GEN-BASIC, Pack Number DYNJ42382B;  69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B;  70) PODIATRY PACK, Pack Number DYNJ37297D;  71) PST PACK, Pack Number DYNJ62666;  72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J;  73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A;  74) SHUNT PACK-LF, Pack Number PHS967363W;  75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242;  76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X;  77) STANDARD ICL PACK-LF, Pack Number PHS895675B;  78) T & A PK-LF, Pack Number DYNJT2408C;  79) THORACIC PACK SHD, Pack Number DYNJ68416C;  80) TONSIL PACK-LF, Pack Number DYNJ0553334I;  81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I;  82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M;  83) VASECTOMY PACK, Pack Number DYNJ65326;  84) VASECTOMY PACK, — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-11. Affected lots/codes: 1) Pack Number DYNJHS0136D:  UDI/DI 10889942848973 (each) 40889942848974 (case), Lot Number 22JBC557Z;  2) Pack Number DYNJ56987B:  UDI/DI 10889942868193 (each) 40889942868194 (case), Lot Number 21EBN072A;  3) Pack Number PHS170994005A:  UDI/DI 10888277754379 (each) 40888277754370 (case), Lot Number 21IMG402A;  4) Pack Number DYNJ54836B:  UDI/DI 10193489574128 (each) 40193489574129 (case), Lot Number 21BBH689A;  5) Pack Number DYNJ58678A:  UDI/DI 10888277781207 (each) 40888277781208 (case), Lot Number 21GMF677A;  6) Pack Number DYNJ63532:  UDI/DI 10193489748468 (each) 40193489748469 (case), Lot Number 22CMB574A;  7) Pack Number DYNJ81702:  UDI/DI 10195327135447 (each) 40195327135448 (case), Lot Number 23CBF695A;  8) Pack Number DYNJ36595D:  UDI/DI 10193489928976 (each) 40193489928977 (case), Lot Number 23CBL653A;  9) Pack Number DYNJ69250A:  UDI/DI 10195327142315 (each) 40195327142316 (case), Lot Number 23HME051A;  10) Pack Number DYNJ50470C:  UDI/DI 10889942922611 (each) 40889942922612 (case), Lot Number 23FME520A;  11) Pack Number DYNJ0115839A:  UDI/DI 10193489901764 (each) 40193489901765 (case), Lot Number 23FME450A;  12) Pack Number PHS396134006A:  UDI/DI 10889942694303 (each) 40889942694304 (case), Lot Number 23DDA331A;  13) Pack Number DYNJ20114Q:  UDI/DI 10193489549249 (each) 40193489549240 (case), Lot Number 22JBF822Z;  14) Pack Number DYNJ0375705L:  UDI/DI 10193489544138 (each) 40193489544139 (case), Lot Number 22GBP901M;  15) Pack Number DYNJ38051F:  UDI/DI 10193489909319 (each) 40193489909310 (case), Lot Number 23EMC825A;  16) Pack Number DYNJ0161358B:  UDI/DI 10889942213269 (each) 40889942213260 (case), Lot Number 23DDA354A;  17) Pack Number DYNJ50844B:  UDI/DI 10889942883271 (each) 40889942883272 (case), Lot Number 22GMD340Z;  18) Pack Number DYNJ46776C:  UDI/DI 10889942893218 (each) 40889942893219 (case), Lot Number 21BBE822A;  19) Pack Number DYNJ40640B:  UDI/DI 10193489292145 (each) 40193489292146 (case), Lot Number 21IME326A;  20) Pack Number DYNJ39385:  UDI/DI 10884389765067 (each) 40884389765068 (case), Lot Number 21IMD121A;  21) Pack Number DYNJ51617A:  UDI/DI 10889942448616 (each) 40889942448617 (case), Lot Number 20LKB440A;  22) Pack Number DYNJ06672I:  UDI/DI 10889942725830 (each) 40889942725831 (case), Lot Number 23BBU700A;  23) Pack Number DYNJ24351D:  UDI/DI 10193489738841 (each) 40193489738842 (case), Lot Number 21LBD180A;  24) Pack Number DYNJ62359A:  UDI/DI 10193489202571 (each) 40193489202572 (case), Lot Number 20AKB925A;  25) Pack Number DYNJ04113C:  UDI/DI 10889942934102 (each) 40889942934103 (case), Lot Number 21EBP303A;  26) Pack Number DYNJ60496:  UDI/DI 10193489506174 (each) 40193489506175 (case), Lot Number 22GBU071Z;  27) Pack Number DYNJ55734C:  UDI/DI 10889942779093 (each) 40889942779094 (case), Lot Number 20FMA632A;  28) Pack Number DYNJ45997C:  UDI/DI 10889942684366 (each) 40889942684367 (case), Lot Number 23GBF502A;  29) Pack Number DYNJ51799G:  UDI/DI 10193489475944 (each) 40193489475945 (case), Lot Number 22CDB465A;  30) Pack Number DYNJ82039:  UDI/DI 10195327163877 (each) 40195327163878 (case), Lot Number 23EBE702A;  31) Pack Number DYNJ904395F:  UDI/DI 10193489701333 (each) 40193489701334 (case), Lot Number 22FBS141Z;  32) Pack Number DYNJ45093B:  UDI/DI 10195327044213 (each) 40195327044214 (case), Lot Number 23BLB075A;  33) Pack Number DYNJ62255A:  UDI/DI 10193489276671 (each) 40193489276672 (case), Lot Number 22GBU775A;  34) Pack Number DYNJ42231B:  UDI/DI 10193489948165 (each) 40193489948166 (case), Lot Number 21HMB550A;  35) Pack Number DYNJ32080L:  UDI/DI 10193489691900 (each) 40193489691901 (case), Lot Number 21BBJ386A;  36) Pack Number DYNJ64857:  UDI/DI 10193489223361 (each) 40193489223362 (case), Lot Number 21IME211A;  37) Pack Number DYNJ56298B:  UDI/DI 10193489415902 (each) 40193489415903 (case), Lot Number 21HME360A;  38) Pack Number DYNJ66065:  UDI/DI 10193489319187 (each) 40193489319188 (case), Lot Number 23LMG850A;  39) Pack Number DYNJ66490B:  UDI/DI 10195327472962 (each) 40195327472963 (case), Lot Number 23HMC391A;  40) Pack Number DYNJ65380A:  UDI/DI 10195327418083 (each) 40195327418084 (case), Lot Number 23LMF918A;  41) Pack Number DYNJ53221B:  UDI/DI 10193489922288 (each) 40193489922289 (case), Lot Number 23GMC211A;  42) Pack Number DYNJ48058A:  UDI/DI 10193489325669 (each) 40193489325660 (case), Lot Number 21JMH979A;  43) Pack Number DYNJ67484A:  UDI/DI 10195327020743 (each) 40195327020744 (case), Lot Number 23DME735A;  44) Pack Number DYNJ51996:  UDI/DI 10889942233205 (each) 40889942233206 (case), Lot Number 21BBG178A;  45) Pack Number DYNJ24599I:  UDI/DI 10193489315141 (each) 40193489315142 (case), Lot Number 21IMH674A;  46) Pack Number DYNJ52305D:  UDI/DI 10195327028572 (each) 40195327028573 (case), Lot Number 22JBU974A;  47) Pack Number DYNJ81562:  UDI/DI 10195327122539 (each) 40195327122530 (case), Lot Number 22JBW597A;  48) Pack Number DYNJ43021B:  UDI/DI 10193489258851 (each) 40193489258852 (case), Lot Number 21GMC689A;  49) Pack Number DYNJ69286:  UDI/DI 10193489922189 (each) 40193489922180 (case), Lot Number 23IMF699A;  50) Pack Number DYNJ0551383P:  UDI/DI 10889942962143 (each) 40889942962144 (case), Lot Number 21GMB523A;  51) Pack Number DYNJ21408D:  UDI/DI 10195327053642 (each) 40195327053643 (case), Lot Number 21LMF738A;  52) Pack Number DYNJ58872A:  UDI/DI 10193489751871 (each) 40193489751872 (case), Lot Number 23JBW564A;  53) Pack Number DYNDH1775A:  UDI/DI 10195327362218 (each) 40195327362219 (case), Lot Number 23LBM803Z;  54) Pack Number DYNJ32216B:  UDI/DI 10193489546101 (each) 40193489546102 (case), Lot Number 21BBF074A;  55) Pack Number DYNJ62104A:  UDI/DI 10193489763713 (each) 40193489763714 (case), Lot Number 23FBO390A;  56) Pack Number DYNJ60124B:  UDI/DI 10193489982855 (each) 40193489982856 (case), Lot Number 21LMG031A;  57) Pack Number DYNJ38246A:  UDI/DI 10884389757772 (each) 40884389757773 (case), Lot Number 23BBQ828A;  58) Pack Number DYNJ65488B:  UDI/DI 10193489443646 (each) 40193489443647 (case), Lot Number 23LMG039A;  59) Pack Number DYNJ44505B:  UDI/DI 10889942379248 (each) 40889942379249 (case), Lot Number 20BDB430A;  60) Pack Number DYNJ64961A:  UDI/DI 10193489416039 (each) 40193489416030 (case), Lot Number 23IMF244A;  61) Pack Number DYNJ40062K:  UDI/DI 10195327493325 (each) 40195327493326 (case), Lot Number 23LMF453A;  62) Pack Number DYNJ21240J:  UDI/DI 10889942931378 (each) 40889942931379 (case), Lot Number 21IMH809A;  63) Pack Number DYNJ51725B:  UDI/DI 10193489538731 (each) 40193489538732 (case), Lot Number 21KBJ357A;  64) Pack Number DYNJ55355B:  UDI/DI 10195327173784 (each) 40195327173785 (case), Lot Number 23CBN280A;  65) Pack Number DYNJ59461C:  UDI/DI 10195327510107 (each) 40195327510108 (case), Lot Number 24ABA333Z;  66) Pack Number DYNJ43754B:  UDI/DI 10193489808964 (each) 40193489808965 (case), Lot Number 20HMD448A;  67) Pack Number DYNJ62501:  UDI/DI 10193489664829 (each) 40193489664820 (case), Lot Number 21LBB961A;  68) Pack Number DYNJ42382B:  UDI/DI 10195327253288 (each) 40195327253289 (case), Lot Number 23LMG144A;  69) Pack Number DYNJ41824B:  UDI/DI 10889942933488 (each) 40889942933489 (case), Lot Number 21LBW098A;  70) Pack Number DYNJ37297D:  UDI/DI 10193489566567 (each) 40193489566568 (case), Lot Number 21JMH963A;  71) Pack Number DYNJ62666:  UDI/DI 10193489679663 (each) 40193489679664 (case), Lot Number 23BBR333A;  72) Pack Number DYNJ0785683J:  UDI/DI 10193489709315 (each) 40193489709316 (case), Lot Number 23LMD781A;  73) Pack Number DYNJ43502A:  UDI/DI 10193489767858 (each) 40193489767859 (case), Lot Number 21BBI542A;  74) Pack Number PHS967363W:  UDI/DI 10889942924561 (each) 40889942924562 (case), Lot Number 21LME249A;  75) Pack Number DYNJ30242:  UDI/DI 10080196785834 (each) 40080196785835 (case), Lot Number 23LMG145A;  76) Pack Number DYNJ0129513X:  UDI/DI 10195327511876 (each) 40195327511877 (case), Lot Number 23LMG678A;  77) Pack Number PHS895675B:  UDI/DI 10193489418316 (each) 40193489418317 (case), Lot Number 22IMB409A;  78) Pack Number DYNJT2408C:  UDI/DI 10884389367643 (each) 40884389367644 (case), Lot Number 21AMA394A;  79) Pack Number DYNJ68416C:  UDI/DI 10195327341688 (each) 40195327341689 (case), Lot Number 23LBS810Z;  80) Pack Number DYNJ0553334I:  UDI/DI 10193489513646 (each) 40193489513647 (case), Lot Number 23HME093A;  81) Pack Number DYNJ0375928I:  UDI/DI 10193489544220 (each) 40193489544221 (case), Lot Number 23CBB970A;  82) Pack Number DYNJ0416615M:  UDI/DI 10195327518936 (each) 40195327518937 (case), Lot Number 24DMC685Z;  83) Pack Number DYNJ65326:  UDI/DI 10193489267587 (each) 40193489267588 (case), Lot Number 21LBG918A;  84) Pack Number DYNJ84729:  UDI/DI 10195327407247 (each) 40195327407248 (case), Lot Number 23GBV524A;  85) Pack Number DYNJ57459A:  UDI/DI 10888277759596 (each) 40888277759597 (case), Lot Number 22GBE165A;  86) Pack Number LINQKIT:  10193489709827 (each) 40193489709828 (case), Lot Number 22GDB223A;  87) Pack Number LINQKIT:  10193489709827 (each) 40193489709828 (case), Lot Number 23EDA439A. 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-1444-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1444-2025&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1444-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1444-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1444-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1444-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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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
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      "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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