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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1788-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "COOK MEDICAL Spectrum¿ Central Venous Catheter Set:  Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983;   Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754;   Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986;   Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984;   Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752;   Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985;   Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995;   Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996;   Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997;   Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817;   Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537;   Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539;   Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005;   Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803;   Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008;   Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006;   Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007;   Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765;   Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825;   Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809;   Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599;   Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827;   Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829;   Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.",
  "description": "FDA recall Z-1788-2026 — Cook Incorporated is recalling COOK MEDICAL Spectrum¿ Central Venous Catheter Set:  Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983;   Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754;   Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986;   Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984;   Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752;   Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985;   Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995;   Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996;   Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997;   Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817;   Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537;   Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539;   Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005;   Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803;   Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008;   Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006;   Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007;   Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765;   Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825;   Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809;   Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599;   Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827;   Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829;   Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810. (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/",
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  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "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/",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1788-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "COOK MEDICAL Spectrum¿ Central Venous Catheter Set:  Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983;   Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754;   Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986;   Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984;   Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752;   Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985;   Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995;   Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996;   Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997;   Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817;   Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537;   Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539;   Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005;   Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803;   Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008;   Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006;   Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007;   Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765;   Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825;   Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809;   Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599;   Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827;   Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829;   Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cook Incorporated"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1788-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1788-2026: Cook Incorporated is recalling COOK MEDICAL Spectrum¿ Central Venous Catheter Set:  Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983;   Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754;   Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986;   Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984;   Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752;   Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985;   Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995;   Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996;   Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997;   Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817;   Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537;   Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539;   Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005;   Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803;   Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008;   Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006;   Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007;   Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765;   Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825;   Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809;   Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599;   Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827;   Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829;   Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.",
      "text": "The FDA logged enforcement record Z-1788-2026: Cook Incorporated is voluntarily recalling COOK MEDICAL Spectrum¿ Central Venous Catheter Set:  Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983;   Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754;   Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986;   Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984;   Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752;   Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985;   Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995;   Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996;   Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997;   Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817;   Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537;   Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539;   Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005;   Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803;   Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008;   Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006;   Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007;   Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765;   Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825;   Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809;   Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599;   Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827;   Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829;   Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810. — reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-05. Affected lots/codes: Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260424(10)15569919, Lot Number 15569919;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260403(10)15520378, Lot Number 15520378;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15487727, Lot Number 15487727;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15484947, Lot Number 15484947;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)16617145, Lot Number 16617145;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617419, Lot Number NS16617419;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617420, Lot Number NS16617420;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620091, Lot Number NS16620091;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620092, Lot Number NS16620092;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620093, Lot Number NS16620093;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620094, Lot Number NS16620094;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620414, Lot Number NS16620414;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620415, Lot Number NS16620415;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620416, Lot Number NS16620416;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622160, Lot Number NS16622160;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622161, Lot Number NS16622161;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622162, Lot Number NS16622162;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622163, Lot Number NS16622163;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622164, Lot Number NS16622164;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622165, Lot Number NS16622165;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622166, Lot Number NS16622166;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622167, Lot Number NS16622167;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622168, Lot Number NS16622168;  Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280602(10)NS16625835, Lot Number NS16625835;  Reference Part Number C-UDLM-401J-ABRM-HC-CAH, UDI (01)00827002247543(17)260619(10)NS15668028, Lot Number NS15668028;  Reference Part Number C-UDLM-401J-ABRM-HC-CAH, UDI (01)00827002247543(17)260227(10)NS15473245, Lot Number NS15473245;  Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15282739, Lot Number NS15282739;  Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15282763, Lot Number NS15282763;  Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15583873, Lot Number NS15583873;  Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)280714(10)NS16692824, Lot Number NS16692824;  Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260314(10)15557442, Lot Number 15557442;  Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260314(10)15520367, Lot Number 15520367;  Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260220(10)15518160, Lot Number 15518160;  Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260327(10)15594051, Lot Number 15594051;  Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280426(10)16576182, Lot Number 16576182;  Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280527(10)16617146, Lot Number 16617146;  Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280529(10)16622169, Lot Number 16622169;  Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280612(10)16642446, Lot Number 16642446;  Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260327(10)NS15583886, Lot Number NS15583886;  Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260314(10)NS15501647, Lot Number NS15501647;  Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260220(10)NS15514024, Lot Number NS15514024;  Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)280331(10)NS16534729, Lot Number NS16534729;  Reference Part Number C-UDLM-401J-RSC-ABRM-HC, UDI (01)00827002439856(17)280423(10)16572552, Lot Number 16572552;  Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280311(10)16505314, Lot Number 16505314;  Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280412(10)16554636, Lot Number 16554636;  Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280416(10)16559432, Lot Number 16559432;  Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280423(10)16572551, Lot Number 16572551;  Reference Part Number C-UDLM-501J-PED-ABRM-HC, UDI (01)00827002439962(17)260619(10)NS15582078, Lot Number NS15582078;  Reference Part Number C-UDLM-501J-RSC-ABRM-HC, UDI (01)00827002439979(17)280428(10)NS16577963, Lot Number NS16577963;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280206(10)NS16454754, Lot Number NS16454754;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280206(10)NS16454756, Lot Number NS16454756;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280505(10)NS16587983, Lot Number NS16587983;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280521(10)NS16612427, Lot Number NS16612427;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280528(10)NS16620419, Lot Number NS16620419;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280623(10)NS16657119, Lot Number NS16657119;  Reference Part Number C-UQLM-1001J-ABRM-HC-RD, UDI (01)00827002515376(17)260417(10)15478180, Lot Number 15478180;  Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, UDI (01)00827002515390(17)280402(10)16539971, Lot Number 16539971;  Reference Part Number C-UTLM-501J-ABRM-HC, UDI (01)00827002440050(17)260626(10)15628883, Lot Number 15628883;  Reference Part Number C-UTLM-501J-ABRM-HC, UDI (01)00827002440050(17)260130(10)15496521, Lot Number 15496521;  Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)260626(10)NS15660282, Lot Number NS15660282;  Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)260626(10)NS15628880, Lot Number NS15628880;  Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)280505(10)NS16588033, Lot Number NS16588033;  Reference Part Number C-UTLM-501J-LSC-ABRM-HC, UDI (01)00827002440081(17)280402(10)16539976, Lot Number 16539976;  Reference Part Number C-UTLM-501J-LSC-ABRM-HC, UDI (01)00827002440081(17)280416(10)NS16493943XX, Lot Number NS16493943XX;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260710(10)NS15643882, Lot Number NS15643882;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260626(10)NS15683399, Lot Number NS15683399;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260327(10)NS15559871, Lot Number NS15559871;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260327(10)NS15597521, Lot Number NS15597521;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260213(10)NS15489151, Lot Number NS15489151;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280303(10)NS16490614, Lot Number NS16490614;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280304(10)NS16493940, Lot Number NS16493940;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280417(10)NS16562685, Lot Number NS16562685; 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A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1788-2026&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-1788-2026&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-1788-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1788-2026 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-1788-2026&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-1788-2026&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-1788-2026/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",
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        "adjudged": false,
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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          "item": {
            "Field": "Recall number",
            "Value": "Z-1788-2026",
            "Status": "recorded"
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        },
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          "position": 2,
          "item": {
            "Field": "Product type",
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            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
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            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Cook Incorporated",
            "Status": "recorded"
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        },
        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-03-05",
            "Status": "recorded"
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 Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280416(10)16559432, Lot Number 16559432;  Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280423(10)16572551, Lot Number 16572551;  Reference Part Number C-UDLM-501J-PED-ABRM-HC, UDI (01)00827002439962(17)260619(10)NS15582078, Lot Number NS15582078;  Reference Part Number C-UDLM-501J-RSC-ABRM-HC, UDI (01)00827002439979(17)280428(10)NS16577963, Lot Number NS16577963;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280206(10)NS16454754, Lot Number NS16454754;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280206(10)NS16454756, Lot Number NS16454756;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280505(10)NS16587983, Lot Number NS16587983;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280521(10)NS16612427, Lot Number NS16612427;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280528(10)NS16620419, Lot Number NS16620419;  Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280623(10)NS16657119, Lot Number NS16657119;  Reference Part Number C-UQLM-1001J-ABRM-HC-RD, UDI (01)00827002515376(17)260417(10)15478180, Lot Number 15478180;  Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, UDI (01)00827002515390(17)280402(10)16539971, Lot Number 16539971;  Reference Part Number C-UTLM-501J-ABRM-HC, UDI (01)00827002440050(17)260626(10)15628883, Lot Number 15628883;  Reference Part Number C-UTLM-501J-ABRM-HC, UDI (01)00827002440050(17)260130(10)15496521, Lot Number 15496521;  Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)260626(10)NS15660282, Lot Number NS15660282;  Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)260626(10)NS15628880, Lot Number NS15628880;  Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)280505(10)NS16588033, Lot Number NS16588033;  Reference Part Number C-UTLM-501J-LSC-ABRM-HC, UDI (01)00827002440081(17)280402(10)16539976, Lot Number 16539976;  Reference Part Number C-UTLM-501J-LSC-ABRM-HC, UDI (01)00827002440081(17)280416(10)NS16493943XX, Lot Number NS16493943XX;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260710(10)NS15643882, Lot Number NS15643882;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260626(10)NS15683399, Lot Number NS15683399;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260327(10)NS15559871, Lot Number NS15559871;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260327(10)NS15597521, Lot Number NS15597521;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260213(10)NS15489151, Lot Number NS15489151;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280303(10)NS16490614, Lot Number NS16490614;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280304(10)NS16493940, Lot Number NS16493940;  Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280417(10)NS16562685, Lot Number NS16562685;  Reference Part Number C-UTLM-501J-RSC-ABRM-HC, UDI (01)00827002440074(17)260327(10)15484937, Lot Number 15484937;  Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, UDI (01)00827002247659(17)280328(10)NS16532973, Lot Number NS16532973;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15550737, Lot Number 15550737;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15553839, Lot Number 15553839;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15565537, Lot Number 15565537;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260327(10)15520384, Lot Number 15520384;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260713(10)15655329, Lot Number 15655329;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280318(10)16514973, Lot Number 16514973;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280331(10)16535286, Lot Number 16535286;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280411(10)16554189, Lot Number 16554189;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280414(10)16556349, Lot Number 16556349;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280430(10)16580721, Lot Number 16580721;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280502(10)16584953, Lot Number 16584953;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280602(10)16625683, Lot Number 16625683;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280602(10)16625826, Lot Number 16625826;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280606(10)16634342, Lot Number 16634342;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280609(10)16636211, Lot Number 16636211;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280609(10)16636220, Lot Number 16636220;  Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280611(10)16639240, Lot Number 16639240;  Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280318(10)16514972, Lot Number 16514972;  Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280328(10)16532975, Lot Number 16532975;  Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280412(10)16554638, Lot Number 16554638;  Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280417(10)16562523, Lot Number 16562523;  Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280429(10)16579251, Lot Number 16579251;  Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, UDI (01)00827002535992(17)260410(10)15518162, Lot Number 15518162;  Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, UDI (01)00827002535992(17)260822(10)15586027, Lot Number 15586027;  Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, UDI (01)00827002478275(17)280401(10)NS16537254, Lot Number NS16537254;  Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, UDI (01)00827002478275(17)280501(10)NS16582898, Lot Number NS16582898;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15660266, Lot Number 15660266;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15655331, Lot Number 15655331;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15683408, Lot Number 15683408;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280414(10)16556179, Lot Number 16556179;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280414(10)16556350, Lot Number 16556350;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280602(10)16625673, Lot Number 16625673;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280602(10)16625817, Lot Number 16625817;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678414, Lot Number 16678414;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678420, Lot Number 16678420;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678428, Lot Number 16678428;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280708(10)16683763, Lot Number 16683763;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280708(10)16683788, Lot Number 16683788;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)260403(10)15687199, Lot Number 15687199;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280412(10)16554639, Lot Number 16554639;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280415(10)16557470, Lot Number 16557470;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280602(10)16625682, Lot Number 16625682;  Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280612(10)16642011, Lot Number 16642011.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}