{
  "@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-1836-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Kits:  1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775;   2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026;   3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673;   4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817;   5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245;   6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247;   7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928;   8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011;   9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273;   10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268;   11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097;   12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387;   13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435;   14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521;   15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743;   16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078;   17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542;   18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071;   19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254;   20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439;   21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773;   22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099;   23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653;   24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326;   25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148;   26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428;   27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135;   28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618;   29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531;   30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137;   31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661;   32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662;   33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001;   34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432;   35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312;   36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273;   37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202;   38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189;   39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014;   40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047;   41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503;   42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527;   43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712;   44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412;   45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712;   46) MTS PEDS LFT   RT HRT-SUNRISE HO, Model Number: 601905414;   47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072;   48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361;   49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411;   50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921;   51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581;   52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001;   53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A;   54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D;   55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B;   56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D;   57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C;   58) ANGIO TRAY, Model Number: DYNJ43278C;   59) CARDIAC LEG PACK, Model Number: DYNJ44065C;   60) EP PACK, Model Number: DYNJ55512A;   61) VASCULAR PACK, Model Number: DYNJ58522A;   62) PERIPHERAL CATH, Model Number: DYNJ59220C;   63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A;   64) C V MINOR PACK, Model Number: DYNJ64862B;   65) ENDOVASCULAR PACK, Model Number: DYNJ65926",
  "description": "FDA recall Z-1836-2026 — Medline Industries, LP is recalling Medline Kits:  1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775;   2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026;   3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673;   4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817;   5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245;   6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247;   7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928;   8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011;   9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273;   10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268;   11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097;   12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387;   13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435;   14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521;   15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743;   16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078;   17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542;   18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071;   19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254;   20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439;   21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773;   22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099;   23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653;   24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326;   25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148;   26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428;   27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135;   28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618;   29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531;   30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137;   31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661;   32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662;   33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001;   34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432;   35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312;   36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273;   37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202;   38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189;   39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014;   40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047;   41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503;   42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527;   43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712;   44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412;   45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712;   46) MTS PEDS LFT   RT HRT-SUNRISE HO, Model Number: 601905414;   47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072;   48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361;   49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411;   50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921;   51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581;   52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001;   53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A;   54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D;   55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B;   56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D;   57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C;   58) ANGIO TRAY, Model Number: DYNJ43278C;   59) CARDIAC LEG PACK, Model Number: DYNJ44065C;   60) EP PACK, Model Number: DYNJ55512A;   61) VASCULAR PACK, Model Number: DYNJ58522A;   62) PERIPHERAL CATH, Model Number: DYNJ59220C;   63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A;   64) C V MINOR PACK, Model Number: DYNJ64862B;   65) ENDOVASCULAR PACK, Model Number: DYNJ65926 (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-1836-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Kits:  1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775;   2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026;   3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673;   4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817;   5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245;   6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247;   7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928;   8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011;   9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273;   10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268;   11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097;   12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387;   13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435;   14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521;   15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743;   16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078;   17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542;   18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071;   19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254;   20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439;   21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773;   22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099;   23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653;   24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326;   25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148;   26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428;   27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135;   28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618;   29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531;   30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137;   31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661;   32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662;   33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001;   34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432;   35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312;   36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273;   37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202;   38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189;   39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014;   40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047;   41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503;   42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527;   43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712;   44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412;   45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712;   46) MTS PEDS LFT   RT HRT-SUNRISE HO, Model Number: 601905414;   47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072;   48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361;   49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411;   50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921;   51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581;   52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001;   53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A;   54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D;   55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B;   56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D;   57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C;   58) ANGIO TRAY, Model Number: DYNJ43278C;   59) CARDIAC LEG PACK, Model Number: DYNJ44065C;   60) EP PACK, Model Number: DYNJ55512A;   61) VASCULAR PACK, Model Number: DYNJ58522A;   62) PERIPHERAL CATH, Model Number: DYNJ59220C;   63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A;   64) C V MINOR PACK, Model Number: DYNJ64862B;   65) ENDOVASCULAR PACK, Model Number: DYNJ65926",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1836-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1836-2026: Medline Industries, LP is recalling Medline Kits:  1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775;   2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026;   3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673;   4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817;   5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245;   6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247;   7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928;   8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011;   9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273;   10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268;   11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097;   12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387;   13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435;   14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521;   15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743;   16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078;   17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542;   18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071;   19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254;   20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439;   21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773;   22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099;   23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653;   24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326;   25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148;   26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428;   27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135;   28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618;   29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531;   30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137;   31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661;   32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662;   33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001;   34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432;   35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312;   36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273;   37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202;   38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189;   39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014;   40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047;   41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503;   42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527;   43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712;   44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412;   45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712;   46) MTS PEDS LFT   RT HRT-SUNRISE HO, Model Number: 601905414;   47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072;   48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361;   49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411;   50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921;   51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581;   52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001;   53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A;   54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D;   55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B;   56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D;   57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C;   58) ANGIO TRAY, Model Number: DYNJ43278C;   59) CARDIAC LEG PACK, Model Number: DYNJ44065C;   60) EP PACK, Model Number: DYNJ55512A;   61) VASCULAR PACK, Model Number: DYNJ58522A;   62) PERIPHERAL CATH, Model Number: DYNJ59220C;   63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A;   64) C V MINOR PACK, Model Number: DYNJ64862B;   65) ENDOVASCULAR PACK, Model Number: DYNJ65926",
      "text": "The FDA logged enforcement record Z-1836-2026: Medline Industries, LP is voluntarily recalling Medline Kits:  1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775;   2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026;   3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673;   4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817;   5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245;   6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247;   7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928;   8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011;   9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273;   10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268;   11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097;   12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387;   13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435;   14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521;   15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743;   16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078;   17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542;   18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071;   19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254;   20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439;   21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773;   22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099;   23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653;   24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326;   25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148;   26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428;   27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135;   28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618;   29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531;   30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137;   31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661;   32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662;   33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001;   34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432;   35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312;   36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273;   37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202;   38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189;   39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014;   40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047;   41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503;   42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527;   43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712;   44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412;   45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712;   46) MTS PEDS LFT   RT HRT-SUNRISE HO, Model Number: 601905414;   47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072;   48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361;   49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411;   50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921;   51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581;   52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001;   53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A;   54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D;   55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B;   56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D;   57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C;   58) ANGIO TRAY, Model Number: DYNJ43278C;   59) CARDIAC LEG PACK, Model Number: DYNJ44065C;   60) EP PACK, Model Number: DYNJ55512A;   61) VASCULAR PACK, Model Number: DYNJ58522A;   62) PERIPHERAL CATH, Model Number: DYNJ59220C;   63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A;   64) C V MINOR PACK, Model Number: DYNJ64862B;   65) ENDOVASCULAR PACK, Model Number: DYNJ65926 — reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-25. Affected lots/codes: 1) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 183372; 2) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 185190; 3) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 106008; 4) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 117378; 5) 60022673, UDI-DI: 10193489041538(each), 20193489041535(case), Lot Number: 176180; 6) 60030817, UDI-DI: 10193489041972(each), 20193489041979(case), Lot Number: 185193; 7) 60031245, UDI-DI: 10193489042214(each), 20193489042211(case), Lot Number: 183374; 8) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 174370; 9) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 184424; 10) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 185080; 11) 60031928, UDI-DI: 10193489042276(each), 20193489042273(case), Lot Number: 185195; 12) 60033011, UDI-DI: 10193489042429(each), 20193489042426(case), Lot Number: 181365; 13) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 179872; 14) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 183375; 15) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 140365; 16) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 170084; 17) 60050097, UDI-DI: 10193489043242(each), 20193489043249(case), Lot Number: 176186; 18) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 183376; 19) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 185194; 20) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 187370; 21) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 183377; 22) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 187371; 23) 60070521, UDI-DI: 10193489044164(each), 20193489044161(case), Lot Number: 185196; 24) 60071743, UDI-DI: 10193489044348(each), 20193489044345(case), Lot Number: 176190; 25) 60090078, UDI-DI: 10193489044829(each), 20193489044826(case), Lot Number: 185197; 26) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 181373; 27) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 185198; 28) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 176193; 29) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 185189; 30) 60100254, UDI-DI: 10193489045024(each), 20193489045021(case), Lot Number: 185188; 31) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 181369; 32) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 185203; 33) 60101773, UDI-DI: 10193489045451(each), 20193489045458(case), Lot Number: 181364; 34) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 181370; 35) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 185204; 36) 60132653, UDI-DI: 10193489047332(each), 20193489047339(case), Lot Number: 181381; 37) 60138326, UDI-DI: 10193489047653(each), 20193489047650(case), Lot Number: 185205; 38) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 183382; 39) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 185207; 40) 60160428, UDI-DI: 10193489048773(each), 20193489048770(case), Lot Number: 181100; 41) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 177936; 42) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 185208; 43) 60163618, UDI-DI: 10193489049251(each), 20193489049258(case), Lot Number: 140392; 44) 60181531, UDI-DI: 10193489049619(each), 20193489049616(case), Lot Number: 185209; 45) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 185522; 46) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 187343; 47) 60182661, UDI-DI: 10193489049794(each), 20193489049791(case), Lot Number: 176203; 48) 60183662, UDI-DI: 10193489050080(each), 20193489050087(case), Lot Number: 181371; 49) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 177939; 50) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 185210; 51) 60185432, UDI-DI: 10193489050325(each), 20193489050322(case), Lot Number: 184739; 52) 60191312, UDI-DI: 10193489050820(each), 20193489050827(case), Lot Number: 185212; 53) 60194273, UDI-DI: 10193489051094(each), 20193489051091(case), Lot Number: 133064; 54) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 181368; 55) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 187374; 56) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 176208; 57) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 181375; 58) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 185213; 59) 60210014, UDI-DI: 10193489051766(each), 20193489051763(case), Lot Number: 187375; 60) 60210047, UDI-DI: 10193489051797(each), 20193489051794(case), Lot Number: 181378; 61) 60230503, UDI-DI: 10193489053098(each), 20193489053095(case), Lot Number: 185214; 62) 60700527, UDI-DI: 10193489057171(each), 20193489057178(case), Lot Number: 185215; 63) 600503712, UDI-DI: 10193489070095(each), 20193489070092(case), Lot Number: 185217; 64) 601010412, UDI-DI: 10193489070613(each), 20193489070610(case), Lot Number: 185220; 65) 601222712, UDI-DI: 10193489070910(each), 20193489070917(case), Lot Number: 176212; 66) 601905414, UDI-DI: 10193489072105(each), 20193489072102(case), Lot Number: 181379; 67) 601905414, UDI-DI: 10193489072105(each), 20193489072102(case), Lot Number: 185221; 68) 606119072, UDI-DI: 10193489073461(each), 20193489073468(case), Lot Number: 106750; 69) 6010030361, UDI-DI: 10193489108033(each), 20193489108030(case), Lot Number: 184480; 70) 6010128411, UDI-DI: 10193489093728(each), 20193489093725(case), Lot Number: 181376; 71) 6010128411, UDI-DI: 10193489093728(each), 20193489093725(case), Lot Number: 185223; 72) 6019705921, UDI-DI: 10193489096156(each), 20193489096153(case), Lot Number: 185352; 73) 6019705921, UDI-DI: 10193489096156(each), 20193489096153(case), Lot Number: 185354; 74) 6020410581, UDI-DI: 10193489131598(each), 20193489131595(case), Lot Number: 155372; 75) 6061073001, UDI-DI: 10193489095692(each), 20193489095699(case), Lot Number: 167702; 76) 6010088152A, UDI-DI: 10193489141276(each), 20193489141273(case), Lot Number: 185224; 77) DYNJVB1077D, UDI-DI: 10198459589270(each), 40198459589271(case), Lot Number: 25KLA735; 78) DYNJVB1302B, UDI-DI: 10195327625429(each), 40195327625420(case), Lot Number: 25LLA560; 79) DYNJVB1302B, UDI-DI: 10195327625429(each), 40195327625420(case), Lot Number: 25KLA369; 80) DYNJ40632D, UDI-DI: 10198459198212(each), 40198459198213(case), Lot Number: 25JML198; 81) DYNJ40633C, UDI-DI: 10198459198229(each), 40198459198220(case), Lot Number: 24KMG184; 82) DYNJ40633C, UDI-DI: 10198459198229(each), 40198459198220(case), Lot Number: 25EMF185; 83) DYNJ43278C, UDI-DI: 10193489957358(each), 40193489957359(case), Lot Number: 25DBU258; 84) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22ABO333; 85) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22DBN254; 86) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22IBJ531; 87) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23ABN017; 88) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23BBI303; 89) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23DBG355; 90) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23FBG335; 91) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23GBR632; 92) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23IBB714; 93) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23JBU288; 94) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24ABA045; 95) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24BBH849; 96) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24EBA787; 97) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24FBN083; 98) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24GBX937; 99) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24IBU804; 100) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24KBU070; 101) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25ABB637; 102) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25BBT277; 103) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25DBL306; 104) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22HBI765; 105) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24BBE157; 106) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25EBU657; 107) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 22FBI713; 108) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 22FBR989; 109) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 23DBR938; 110) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 23DBR937; 111) DYNJ58522A, UDI-DI: 10198459135781(each), 40198459135782(case), Lot Number: 25CBC459; 112) DYNJ59220C, UDI-DI: 10198459484551(each), 40198459484552(case), Lot Number: 25JLA710; 113) DYNJ62409A, UDI-DI: 10193489218671(each), 40193489218672(case), Lot Number: 25CBD234; 114) DYNJ64862B, UDI-DI: 10195327053703(each), 40195327053704(case), Lot Number: 24IBJ708; 115) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21HBB198; 116) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21IBK707; 117) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21LBH265; 118) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 22ABZ745; 119) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 22EBO031; 120) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 22FBK919; 121) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23ABG784; 122) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23BBM271; 123) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23DBJ192; 124) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23EBF015; 125) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23GBC290; 126) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24BBH874; 127) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24CBD055; 128) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24DBO541; 129) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24FBQ427; 130) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24IBL349; 131) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24KBE756; 132) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24KBR816; 133) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 25DBI909; 134) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21HBO230; 135) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23EBS139; 136) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 25GBJ642; 137) DYNJ82863C, UDI-DI: 10198459103315(each), 40198459103316(case), Lot Number: 25CBP219; 138) DYNJ83913D, UDI-DI: 10198459515378(each), 40198459515379(case), Lot Number: 25LMI880; 139) DYNJ85073B, UDI-DI: 10198459167164(each), 40198459167165(case), Lot Number: 25EMF051; 140) DYNJ88292, UDI-DI: 10198459142079(each), 40198459142070(case), Lot Number: 24JBQ452; 141) DYNJ88292, UDI-DI: 10198459142079(each), 40198459142070(case), Lot Number: 25EBR618; 142) DYNJ89865, UDI-DI: 10198459296765(each), 40198459296766(case), Lot Number: 25CBP998; 143) DYNJ906951D, UDI-DI: 10198459132490(each), 40198459132491(case), Lot Number: 25JBR478; 144) DYNJ908389B, UDI-DI: 10198459122903(each), 40198459122904(case), Lot Number: 25GBI395; 145) VASC1068, UDI-DI: 10889942527908(each), 40889942527909(case), Lot Number: 21ABE418; 146) VASC1068, UDI-DI: 10889942527908(each), 40889942527909(case), Lot Number: 21ABA917; 147) VASC1127, UDI-DI: 10889942834273(each), 40889942834274(case), Lot Number: 25HBQ004; 148) VASC1324, UDI-DI: 10195327126773(each), 40195327126774(case), Lot Number: 25FBD245; 149) VASC1509, UDI-DI: 10195327686581(each), 40195327686582(case), Lot Number: 24IBE174; 150) VASC1824, UDI-DI: 10198459435805(each), 40198459435806(case), Lot Number: 25GBT688; 151) 00-399024AC, UDI-DI: 10198459162442(each), 40198459162443(case), Lot Number: 25KMB256; 152) 00-399024AC, UDI-DI: 10198459162442(each), 40198459162443(case), Lot Number: 25HMD974. 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-1836-2026&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-1836-2026&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-1836-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1836-2026 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-1836-2026&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-1836-2026&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-1836-2026/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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1836-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1836-2026",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medline Industries, LP",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-02-25",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 183372; 2) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 185190; 3) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 106008; 4) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 117378; 5) 60022673, UDI-DI: 10193489041538(each), 20193489041535(case), Lot Number: 176180; 6) 60030817, UDI-DI: 10193489041972(each), 20193489041979(case), Lot Number: 185193; 7) 60031245, UDI-DI: 10193489042214(each), 20193489042211(case), Lot Number: 183374; 8) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 174370; 9) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 184424; 10) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 185080; 11) 60031928, UDI-DI: 10193489042276(each), 20193489042273(case), Lot Number: 185195; 12) 60033011, UDI-DI: 10193489042429(each), 20193489042426(case), Lot Number: 181365; 13) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 179872; 14) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 183375; 15) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 140365; 16) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 170084; 17) 60050097, UDI-DI: 10193489043242(each), 20193489043249(case), Lot Number: 176186; 18) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 183376; 19) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 185194; 20) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 187370; 21) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 183377; 22) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 187371; 23) 60070521, UDI-DI: 10193489044164(each), 20193489044161(case), Lot Number: 185196; 24) 60071743, UDI-DI: 10193489044348(each), 20193489044345(case), Lot Number: 176190; 25) 60090078, UDI-DI: 10193489044829(each), 20193489044826(case), Lot Number: 185197; 26) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 181373; 27) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 185198; 28) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 176193; 29) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 185189; 30) 60100254, UDI-DI: 10193489045024(each), 20193489045021(case), Lot Number: 185188; 31) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 181369; 32) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 185203; 33) 60101773, UDI-DI: 10193489045451(each), 20193489045458(case), Lot Number: 181364; 34) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 181370; 35) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 185204; 36) 60132653, UDI-DI: 10193489047332(each), 20193489047339(case), Lot Number: 181381; 37) 60138326, UDI-DI: 10193489047653(each), 20193489047650(case), Lot Number: 185205; 38) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 183382; 39) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 185207; 40) 60160428, UDI-DI: 10193489048773(each), 20193489048770(case), Lot Number: 181100; 41) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 177936; 42) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 185208; 43) 60163618, UDI-DI: 10193489049251(each), 20193489049258(case), Lot Number: 140392; 44) 60181531, UDI-DI: 10193489049619(each), 20193489049616(case), Lot Number: 185209; 45) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 185522; 46) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 187343; 47) 60182661, UDI-DI: 10193489049794(each), 20193489049791(case), Lot Number: 176203; 48) 60183662, UDI-DI: 10193489050080(each), 20193489050087(case), Lot Number: 181371; 49) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 177939; 50) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 185210; 51) 60185432, UDI-DI: 10193489050325(each), 20193489050322(case), Lot Number: 184739; 52) 60191312, UDI-DI: 10193489050820(each), 20193489050827(case), Lot Number: 185212; 53) 60194273, UDI-DI: 10193489051094(each), 20193489051091(case), Lot Number: 133064; 54) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 181368; 55) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 187374; 56) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 176208; 57) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 181375; 58) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 185213; 59) 60210014, UDI-DI: 10193489051766(each), 20193489051763(case), Lot Number: 187375; 60) 60210047, UDI-DI: 10193489051797(each), 20193489051794(case), Lot Number: 181378; 61) 60230503, UDI-DI: 10193489053098(each), 20193489053095(case), Lot Number: 185214; 62) 60700527, UDI-DI: 10193489057171(each), 20193489057178(case), Lot Number: 185215; 63) 600503712, UDI-DI: 10193489070095(each), 20193489070092(case), Lot Number: 185217; 64) 601010412, UDI-DI: 10193489070613(each), 20193489070610(case), Lot Number: 185220; 65) 601222712, UDI-DI: 10193489070910(each), 20193489070917(case), Lot Number: 176212; 66) 601905414, UDI-DI: 10193489072105(each), 20193489072102(case), Lot Number: 181379; 67) 601905414, UDI-DI: 10193489072105(each), 20193489072102(case), Lot Number: 185221; 68) 606119072, UDI-DI: 10193489073461(each), 20193489073468(case), Lot Number: 106750; 69) 6010030361, UDI-DI: 10193489108033(each), 20193489108030(case), Lot Number: 184480; 70) 6010128411, UDI-DI: 10193489093728(each), 20193489093725(case), Lot Number: 181376; 71) 6010128411, UDI-DI: 10193489093728(each), 20193489093725(case), Lot Number: 185223; 72) 6019705921, UDI-DI: 10193489096156(each), 20193489096153(case), Lot Number: 185352; 73) 6019705921, UDI-DI: 10193489096156(each), 20193489096153(case), Lot Number: 185354; 74) 6020410581, UDI-DI: 10193489131598(each), 20193489131595(case), Lot Number: 155372; 75) 6061073001, UDI-DI: 10193489095692(each), 20193489095699(case), Lot Number: 167702; 76) 6010088152A, UDI-DI: 10193489141276(each), 20193489141273(case), Lot Number: 185224; 77) DYNJVB1077D, UDI-DI: 10198459589270(each), 40198459589271(case), Lot Number: 25KLA735; 78) DYNJVB1302B, UDI-DI: 10195327625429(each), 40195327625420(case), Lot Number: 25LLA560; 79) DYNJVB1302B, UDI-DI: 10195327625429(each), 40195327625420(case), Lot Number: 25KLA369; 80) DYNJ40632D, UDI-DI: 10198459198212(each), 40198459198213(case), Lot Number: 25JML198; 81) DYNJ40633C, UDI-DI: 10198459198229(each), 40198459198220(case), Lot Number: 24KMG184; 82) DYNJ40633C, UDI-DI: 10198459198229(each), 40198459198220(case), Lot Number: 25EMF185; 83) DYNJ43278C, UDI-DI: 10193489957358(each), 40193489957359(case), Lot Number: 25DBU258; 84) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22ABO333; 85) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22DBN254; 86) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22IBJ531; 87) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23ABN017; 88) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23BBI303; 89) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23DBG355; 90) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23FBG335; 91) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23GBR632; 92) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23IBB714; 93) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 23JBU288; 94) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24ABA045; 95) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24BBH849; 96) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24EBA787; 97) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24FBN083; 98) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24GBX937; 99) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24IBU804; 100) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24KBU070; 101) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25ABB637; 102) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25BBT277; 103) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25DBL306; 104) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 22HBI765; 105) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 24BBE157; 106) DYNJ44065C, UDI-DI: 10195327080631(each), 40195327080632(case), Lot Number: 25EBU657; 107) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 22FBI713; 108) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 22FBR989; 109) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 23DBR938; 110) DYNJ55512A, UDI-DI: 10889942765003(each), 40889942765004(case), Lot Number: 23DBR937; 111) DYNJ58522A, UDI-DI: 10198459135781(each), 40198459135782(case), Lot Number: 25CBC459; 112) DYNJ59220C, UDI-DI: 10198459484551(each), 40198459484552(case), Lot Number: 25JLA710; 113) DYNJ62409A, UDI-DI: 10193489218671(each), 40193489218672(case), Lot Number: 25CBD234; 114) DYNJ64862B, UDI-DI: 10195327053703(each), 40195327053704(case), Lot Number: 24IBJ708; 115) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21HBB198; 116) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21IBK707; 117) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21LBH265; 118) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 22ABZ745; 119) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 22EBO031; 120) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 22FBK919; 121) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23ABG784; 122) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23BBM271; 123) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23DBJ192; 124) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23EBF015; 125) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23GBC290; 126) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24BBH874; 127) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24CBD055; 128) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24DBO541; 129) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24FBQ427; 130) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24IBL349; 131) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24KBE756; 132) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 24KBR816; 133) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 25DBI909; 134) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 21HBO230; 135) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 23EBS139; 136) DYNJ65926, UDI-DI: 10193489305456(each), 40193489305457(case), Lot Number: 25GBJ642; 137) DYNJ82863C, UDI-DI: 10198459103315(each), 40198459103316(case), Lot Number: 25CBP219; 138) DYNJ83913D, UDI-DI: 10198459515378(each), 40198459515379(case), Lot Number: 25LMI880; 139) DYNJ85073B, UDI-DI: 10198459167164(each), 40198459167165(case), Lot Number: 25EMF051; 140) DYNJ88292, UDI-DI: 10198459142079(each), 40198459142070(case), Lot Number: 24JBQ452; 141) DYNJ88292, UDI-DI: 10198459142079(each), 40198459142070(case), Lot Number: 25EBR618; 142) DYNJ89865, UDI-DI: 10198459296765(each), 40198459296766(case), Lot Number: 25CBP998; 143) DYNJ906951D, UDI-DI: 10198459132490(each), 40198459132491(case), Lot Number: 25JBR478; 144) DYNJ908389B, UDI-DI: 10198459122903(each), 40198459122904(case), Lot Number: 25GBI395; 145) VASC1068, UDI-DI: 10889942527908(each), 40889942527909(case), Lot Number: 21ABE418; 146) VASC1068, UDI-DI: 10889942527908(each), 40889942527909(case), Lot Number: 21ABA917; 147) VASC1127, UDI-DI: 10889942834273(each), 40889942834274(case), Lot Number: 25HBQ004; 148) VASC1324, UDI-DI: 10195327126773(each), 40195327126774(case), Lot Number: 25FBD245; 149) VASC1509, UDI-DI: 10195327686581(each), 40195327686582(case), Lot Number: 24IBE174; 150) VASC1824, UDI-DI: 10198459435805(each), 40198459435806(case), Lot Number: 25GBT688; 151) 00-399024AC, UDI-DI: 10198459162442(each), 40198459162443(case), Lot Number: 25KMB256; 152) 00-399024AC, UDI-DI: 10198459162442(each), 40198459162443(case), Lot Number: 25HMD974",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}