{
  "@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"
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2301-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D;     b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J;   c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G;   d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C;   e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567;   f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N;   g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880;   h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K;   i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067;   j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F;   k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D;   l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F;   m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C;   n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489;   o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A;   p. ENDOVENOUS PACK, Model Number: DYNJ83606;   q. ENT FREE FLAP, Model Number: SYNJ910018B;   r. EP ANGIO PACK, Model Number: DYNJ25749S;   s. EP DRAPE PACK-LF, Model Number: DYNJ47645C;   t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F;   u. EP PACER PACK, Model Number: DYNJ67770;   v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B;   w. EP PROCEDURE PACK, Model Number: DYNJ67771;   x. EP TRAY, Model Number: DYNJ31928D;   y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F;   z. FEM POP PACK, Model Number: DYNJ67487C;   aa. FISTULA PACK, Model Number: DYNJ82711;   bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A;   cc. GENERAL HEART, Model Number: DYNJ907915;   dd. GROTH LASER VEIN CDS, Model Number: CDS984193O;   ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K;   ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198;   gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F;   hh. HEART A PACK, Model Number: DYNJ0541930N;   ii. HEART FAILURE PACK, Model Number: DYNJ64877B;   jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C;   kk. HEART PACK, Model Number: DYNJ48424A;   ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J;   mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B;   nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A;   oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F;   pp. HMT VEIN PACK, Model Number: DYNJ38756B;   qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B;   rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C;   ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A;   tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B;   uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A;   vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A;   ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076;   xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C;   yy. KIT LB OPEN HEART, Model Number: CDS840487G;   zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B;   aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A;   bbb. KIT OPEN HEART, Model Number: DYNJ906113;   ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B;   ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23;   eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A;   fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A;   ggg. KIT VASCULAR RF, Model Number: DYNJ906960A;   hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F;   iii. LASER ABLATION, Model Number: DYNJ48962B;   jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725;   kkk. LASER PACK, Model Number: DYNJ65294;   lll. LB OPEN HEART BOX, Model Number: DYNJ905859B;   mmm. LEE VEIN PACK, Model Number: DYNJ54906B;   nnn. LEG VASCULAR SUPPLY -LF, Model Number: D",
  "description": "FDA recall Z-2301-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D;     b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J;   c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G;   d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C;   e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567;   f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N;   g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880;   h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K;   i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067;   j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F;   k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D;   l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F;   m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C;   n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489;   o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A;   p. ENDOVENOUS PACK, Model Number: DYNJ83606;   q. ENT FREE FLAP, Model Number: SYNJ910018B;   r. EP ANGIO PACK, Model Number: DYNJ25749S;   s. EP DRAPE PACK-LF, Model Number: DYNJ47645C;   t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F;   u. EP PACER PACK, Model Number: DYNJ67770;   v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B;   w. EP PROCEDURE PACK, Model Number: DYNJ67771;   x. EP TRAY, Model Number: DYNJ31928D;   y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F;   z. FEM POP PACK, Model Number: DYNJ67487C;   aa. FISTULA PACK, Model Number: DYNJ82711;   bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A;   cc. GENERAL HEART, Model Number: DYNJ907915;   dd. GROTH LASER VEIN CDS, Model Number: CDS984193O;   ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K;   ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198;   gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F;   hh. HEART A PACK, Model Number: DYNJ0541930N;   ii. HEART FAILURE PACK, Model Number: DYNJ64877B;   jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C;   kk. HEART PACK, Model Number: DYNJ48424A;   ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J;   mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B;   nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A;   oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F;   pp. HMT VEIN PACK, Model Number: DYNJ38756B;   qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B;   rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C;   ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A;   tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B;   uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A;   vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A;   ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076;   xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C;   yy. KIT LB OPEN HEART, Model Number: CDS840487G;   zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B;   aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A;   bbb. KIT OPEN HEART, Model Number: DYNJ906113;   ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B;   ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23;   eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A;   fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A;   ggg. KIT VASCULAR RF, Model Number: DYNJ906960A;   hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F;   iii. LASER ABLATION, Model Number: DYNJ48962B;   jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725;   kkk. LASER PACK, Model Number: DYNJ65294;   lll. LB OPEN HEART BOX, Model Number: DYNJ905859B;   mmm. LEE VEIN PACK, Model Number: DYNJ54906B;   nnn. LEG VASCULAR SUPPLY -LF, Model Number: D (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-2301-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D;     b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J;   c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G;   d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C;   e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567;   f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N;   g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880;   h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K;   i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067;   j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F;   k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D;   l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F;   m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C;   n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489;   o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A;   p. ENDOVENOUS PACK, Model Number: DYNJ83606;   q. ENT FREE FLAP, Model Number: SYNJ910018B;   r. EP ANGIO PACK, Model Number: DYNJ25749S;   s. EP DRAPE PACK-LF, Model Number: DYNJ47645C;   t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F;   u. EP PACER PACK, Model Number: DYNJ67770;   v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B;   w. EP PROCEDURE PACK, Model Number: DYNJ67771;   x. EP TRAY, Model Number: DYNJ31928D;   y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F;   z. FEM POP PACK, Model Number: DYNJ67487C;   aa. FISTULA PACK, Model Number: DYNJ82711;   bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A;   cc. GENERAL HEART, Model Number: DYNJ907915;   dd. GROTH LASER VEIN CDS, Model Number: CDS984193O;   ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K;   ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198;   gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F;   hh. HEART A PACK, Model Number: DYNJ0541930N;   ii. HEART FAILURE PACK, Model Number: DYNJ64877B;   jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C;   kk. HEART PACK, Model Number: DYNJ48424A;   ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J;   mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B;   nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A;   oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F;   pp. HMT VEIN PACK, Model Number: DYNJ38756B;   qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B;   rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C;   ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A;   tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B;   uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A;   vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A;   ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076;   xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C;   yy. KIT LB OPEN HEART, Model Number: CDS840487G;   zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B;   aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A;   bbb. KIT OPEN HEART, Model Number: DYNJ906113;   ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B;   ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23;   eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A;   fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A;   ggg. KIT VASCULAR RF, Model Number: DYNJ906960A;   hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F;   iii. LASER ABLATION, Model Number: DYNJ48962B;   jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725;   kkk. LASER PACK, Model Number: DYNJ65294;   lll. LB OPEN HEART BOX, Model Number: DYNJ905859B;   mmm. LEE VEIN PACK, Model Number: DYNJ54906B;   nnn. LEG VASCULAR SUPPLY -LF, Model Number: D",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2301-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2301-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D;     b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J;   c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G;   d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C;   e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567;   f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N;   g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880;   h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K;   i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067;   j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F;   k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D;   l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F;   m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C;   n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489;   o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A;   p. ENDOVENOUS PACK, Model Number: DYNJ83606;   q. ENT FREE FLAP, Model Number: SYNJ910018B;   r. EP ANGIO PACK, Model Number: DYNJ25749S;   s. EP DRAPE PACK-LF, Model Number: DYNJ47645C;   t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F;   u. EP PACER PACK, Model Number: DYNJ67770;   v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B;   w. EP PROCEDURE PACK, Model Number: DYNJ67771;   x. EP TRAY, Model Number: DYNJ31928D;   y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F;   z. FEM POP PACK, Model Number: DYNJ67487C;   aa. FISTULA PACK, Model Number: DYNJ82711;   bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A;   cc. GENERAL HEART, Model Number: DYNJ907915;   dd. GROTH LASER VEIN CDS, Model Number: CDS984193O;   ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K;   ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198;   gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F;   hh. HEART A PACK, Model Number: DYNJ0541930N;   ii. HEART FAILURE PACK, Model Number: DYNJ64877B;   jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C;   kk. HEART PACK, Model Number: DYNJ48424A;   ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J;   mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B;   nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A;   oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F;   pp. HMT VEIN PACK, Model Number: DYNJ38756B;   qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B;   rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C;   ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A;   tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B;   uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A;   vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A;   ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076;   xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C;   yy. KIT LB OPEN HEART, Model Number: CDS840487G;   zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B;   aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A;   bbb. KIT OPEN HEART, Model Number: DYNJ906113;   ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B;   ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23;   eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A;   fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A;   ggg. KIT VASCULAR RF, Model Number: DYNJ906960A;   hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F;   iii. LASER ABLATION, Model Number: DYNJ48962B;   jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725;   kkk. LASER PACK, Model Number: DYNJ65294;   lll. LB OPEN HEART BOX, Model Number: DYNJ905859B;   mmm. LEE VEIN PACK, Model Number: DYNJ54906B;   nnn. LEG VASCULAR SUPPLY -LF, Model Number: D",
      "text": "The FDA logged enforcement record Z-2301-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D;     b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J;   c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G;   d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C;   e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567;   f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N;   g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880;   h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K;   i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067;   j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F;   k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D;   l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F;   m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C;   n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489;   o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A;   p. ENDOVENOUS PACK, Model Number: DYNJ83606;   q. ENT FREE FLAP, Model Number: SYNJ910018B;   r. EP ANGIO PACK, Model Number: DYNJ25749S;   s. EP DRAPE PACK-LF, Model Number: DYNJ47645C;   t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F;   u. EP PACER PACK, Model Number: DYNJ67770;   v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B;   w. EP PROCEDURE PACK, Model Number: DYNJ67771;   x. EP TRAY, Model Number: DYNJ31928D;   y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F;   z. FEM POP PACK, Model Number: DYNJ67487C;   aa. FISTULA PACK, Model Number: DYNJ82711;   bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A;   cc. GENERAL HEART, Model Number: DYNJ907915;   dd. GROTH LASER VEIN CDS, Model Number: CDS984193O;   ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K;   ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198;   gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F;   hh. HEART A PACK, Model Number: DYNJ0541930N;   ii. HEART FAILURE PACK, Model Number: DYNJ64877B;   jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C;   kk. HEART PACK, Model Number: DYNJ48424A;   ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J;   mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B;   nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A;   oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F;   pp. HMT VEIN PACK, Model Number: DYNJ38756B;   qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B;   rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C;   ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A;   tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B;   uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A;   vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A;   ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076;   xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C;   yy. KIT LB OPEN HEART, Model Number: CDS840487G;   zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B;   aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A;   bbb. KIT OPEN HEART, Model Number: DYNJ906113;   ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B;   ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23;   eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A;   fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A;   ggg. KIT VASCULAR RF, Model Number: DYNJ906960A;   hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F;   iii. LASER ABLATION, Model Number: DYNJ48962B;   jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725;   kkk. LASER PACK, Model Number: DYNJ65294;   lll. LB OPEN HEART BOX, Model Number: DYNJ905859B;   mmm. LEE VEIN PACK, Model Number: DYNJ54906B;   nnn. LEG VASCULAR SUPPLY -LF, Model Number: D — reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-15. Affected lots/codes: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023:    a. Model Number: DYNJ0842825D, UPC Number: 019532728861.  b. Model Number: DYNJ49933I, UPC Number: 019348947168; Model Number: DYNJ49933J, UPC Number: 019532706561.  c. Model Number: DYNJ44808G, UPC Number: 019348987585.  d. Model Number: DYNJ51304B, UPC Number: 088994236595; Model Number: DYNJ51304C, UPC Number: 019348946098.  e. Model Number: DYNJ0678934D, UPC Number: 019348956435; Model Number: DYNJ0678934F, UPC Number: 019348956435; Model Number: DYNJ82567, UPC Number: 019532719803.   f. Model Number: DYNJ0676055N, UPC Number: 019348956435.  g. Model Number: DYNJ63343A, UPC Number: 019348929199; Model Number: DYNJ63343B, UPC Number: 019348947045; Model Number: DYNJ63343D, UPC Number: 019348996760; Model Number: DYNJ63343F, UPC Number: 019532708613; Model Number: DYNJ908880, UPC Number: 019532720343.  h. Model Number: CDS983394I, UPC Number: 019348981995; Model Number: CDS983394J, UPC Number: 019532706987; Model Number: CDS983394K, UPC Number: 019532729258.  i. Model Number: DYNJVB91067, UPC Number: 019348980153.   j. Model Number: DYNJ906354D, UPC Number: 019348998657; Model Number: DYNJ906354F, UPC Number: 019532702150.  k. Model Number: DYNJ0678934I, UPC Number: 019348999786; Model Number: DYNJ44934F, UPC Number: 019348944613; Model Number: DYNJ905726C, UPC Number: 019348994337; Model Number: DYNJ905726D, UPC Number: 019532716151.  l. Model Number: DYNJ42831F, UPC Number: 019348988032.  m. Model Number: DYNJ67750, UPC Number: 019348942917, Model Number: DYNJ67750A, UPC Number: 019348983224, Model Number: DYNJ67750B, UPC Number: 019348991204, Model Number: DYNJ67750C, UPC Number: 019532734136.  n. Model Number: DYNJ80489, UPC Number: 019532704584.   o. Model Number: DYNJ48456C, UPC Number: 019532701586; Model Number: DYNJ69108A, UPC Number: 019532702571.   p. Model Number: DYNJ83606, UPC Number: 019532728485.  q. Model Number: SYNJ910018B, UPC Number: 019532700730.  r. Model Number: DYNJ25749S, UPC Number: 019532705970.  s. Model Number: DYNJ47645C, UPC Number: 019532735517.  t. Model Number: DYNJ59392D, UPC Number: 019532705357; Model Number: DYNJ59392F, UPC Number: 019532713598.  u. Model Number: DYNJ67770, UPC Number: 019348943071.  v. Model Number: DYNJ23456K, UPC Number: 019348996776; Model Number: DYNJ68019, UPC Number: 019348946784; Model Number: DYNJ81716, UPC Number: 019532713806;  Model Number: DYNJ81716A, UPC Number: 019532720385; Model Number: DYNJ81716B, UPC Number: 019532727726.  w. Model Number: DYNJ67771, UPC Number: 019348943072.  x. Model Number: DYNJ31928D, UPC Number: 019532733528.  y. Model Number: DYNJ53480F, UPC Number: 019348942488.  z. Model Number: DYNJ67487C, UPC Number: 019532726074.  aa. Model Number: DYNJ82711, UPC Number: 019532720362.  bb. Model Number: DYNJ69943A, UPC Number: 019532728463.  cc. Model Number: DYNJ907915, UPC Number: 019348994368.  dd. Model Number: CDS984193O, UPC Number: 019348937708.  ee. Model Number: DYNJ46590I, UPC Number: 019348975763; Model Number: DYNJ46590J, UPC Number: 019348947369; Model Number: DYNJ46590K, UPC Number: 019532709400.  ff. Model Number: DYNJ68198, UPC Number: 019348949917.  gg. Model Number: DYNJ51925F, UPC Number: 019532715339.  hh. Model Number: DYNJ0541930N, UPC Number: 019348971892.   ii. Model Number: DYNJ64877B, UPC Number: 019348941589.   jj. Model Number: DYNJ55528A, UPC Number: 088994297663; Model Number: DYNJ55528B, UPC Number: 019532704649; Model Number: DYNJ55528C, UPC Number: 019532724820.  kk. Model Number: DYNJ48424A, UPC Number: 088827792129.  ll. Model Number: DYNJ58365C, UPC Number: 019348945985; Model Number: DYNJ58365F, UPC Number: 019348982057; Model Number: DYNJ58365G, UPC Number: 019348988393; Model Number: DYNJ58365J, UPC Number: 019532701909.  mm. Model Number: DYNJ62851B, UPC Number: 019348927121.  nn. Model Number: DYNJ62850A, UPC Number: 019348978423.  oo. Model Number: DYNJ905495D, UPC Number: 019348983924; Model Number: DYNJ905495F, UPC Number: 019348992493.  pp. Model Number: DYNJ38756B, UPC Number: 019348956435.  qq. Model Number: DYNJ907571A, UPC Number: 019348992612; Model Number: DYNJ907571B, UPC Number: 019532726241.  rr. Model Number: DYNJ40215C, UPC Number: 019532717650.  ss. Model Number: DYNJ52756A, UPC Number: 019348941383.   tt. Model Number: DYNJ47138B, UPC Number: 088994227421.  uu. Model Number: DYNJ82858A, UPC Number: 019532724489.  vv. Model Number: DYNJ82859A, UPC Number: 019532724490.  ww. Model Number: DYNJ66076, UPC Number: 019348931923.  xx. Model Number: DYKMBNDL22C, UPC Number: 019532724096.  yy. Model Number: CDS840487G, UPC Number: 019348967442.  zz. Model Number: DYNJ907262, UPC Number: 019348938515, Model Number: DYNJ907262B, UPC Number: 019532711641.  aaa. Model Number: DYKMBNDL148A, UPC Number: 019532724129.  bbb. Model Number: DYNJ906113, UPC Number: 019348965872.  ccc. Model Number: DYNJ906086B, UPC Number: 019532704635.  ddd. Model Number: DYKMBNDL23, UPC Number: 019348947918.  eee. Model Number: DYNJ906098, UPC Number: 019348963877; Model Number: DYNJ906098A, UPC Number: 019348920945.  fff. Model Number: DYKMBNDL118A, UPC Number: 019532724067.  ggg. Model Number: DYNJ906960A, UPC Number: 019532700259.  hhh.  Model Number: DYNJ56283C, UPC Number: 019348926872; Model Number: DYNJ56283D, UPC Number: 019532709387; Model Number: DYNJ56283F, UPC Number: 019532721185.  iii. Model Number: DYNJ48962B, UPC Number: 088994212967.  jjj. Model Number: DYNJ38995C, UPC Number: 019348971314, Model Number: DYNJ67725, UPC Number: 019348942584.   kkk. Model Number: DYNJ65294, UPC Number: 019348926426.  lll. Model Number: DYNJ905859B, UPC Number: 019348941786.  mmm. Model Number: DYNJ54906B, UPC Number: 019348928963.  nnn. Model Number: DYNJ905626B, UPC Number: 019348963423.  ooo. Model Number: DYNJ81407, UPC Number: 019532711766.  ppp. Model Number: DYNJ41100C, UPC Number: 019348989982.  qqq. Model Number: DYNJ0678934G, UPC Number: 019348956435.  rrr. Model Number: DYNJ902168C, UPC Number: 019348945421.    sss. Model Number: DYNJ908687, UPC Number: 019532714092.  ttt. Model Number: DYNJ61373, UPC Number: 019348957669.  uuu. Model Number: DYNJ901062D, UPC Number: 019348921181; Model Number: DYNJ905641, UPC Number: 019348952766; Model Number: DYNJ905641A, UPC Number: 019532703927; Model Number: DYNJ906371B, UPC Number: 019348981669; Model Number: DYNJ906371C, UPC Number: 019532702146; Model Number: DYNJ906951, UPC Number: 019348929999; Model Number: DYNJ906951A, UPC Number: 019532712835; Model Number: DYNJ908390, UPC Number: 019532708832.  vvv. Model Number: CDS840368M, UPC Number: 019348949162; Model Number: CDS840368N, UPC Number: 019532702036; Model Number: CDS840368P, UPC Number: 019532732286.  www. Model Number: DYNJ45515D, UPC Number: 019348936735; Model Number: DYNJ81610A, UPC Number: 019532731504.  xxx. Model Number: DYNJC9307F, UPC Number: 019348926312; Model Number: DYNJC9307G, UPC Number: 019532703329.  yyy. Model Number: DYNJ82988, UPC Number: 019532722220; Model Number: DYNJ82988A, UPC Number: 019532729331.  zzz. Model Number: DYNJ82987, UPC Number: 019532722211.   aaaa. Model Number: DYNJ0622403O, UPC Number: 088994221921.   bbbb. Model Number: DYNJ66916A, UPC Number: 019348999322.   cccc. Model Number: DYNJ903705I, UPC Number: 019348997955.   dddd. Model Number: DYNJ903706K, UPC Number: 019348999413.   eeee. Model Number: DYNJ53433G, UPC Number: 019532704243; Model Number: DYNJ53433I, UPC Number: 019532707449; Model Number: DYNJ53433J, UPC Number: 019532722292.   ffff. Model Number: DYNJ44122B, UPC Number: 019348923136.   gggg.Model Number: DYNJ904171D, UPC Number: 019348945094; Model Number: DYNJ904171F, UPC Number: 019348943924; Model Number: DYNJ907063A, UPC Number: 019348983381; Model Number: DYNJ908391, UPC Number: 019532708831.   hhhh. Model Number: DYNJ60713, UPC Number: 019348952003; Model Number: DYNJ60713A, UPC Number: 019532701206; Model Number: DYNJ68616, UPC Number: 019348983858; Model Number: DYNJ69036, UPC Number: 019348988394.   iiii. Model Number: DYNJ0349727D, UPC Number: 019532700015.   jjjj. Model Number: DYNJ31148I, UPC Number: 019348956435.   kkkk. Model Number: DYNJ61584A, UPC Number: 019348981281.   llll. Model Number: CDS984231T, UPC Number: 019348962640.   mmmm. Model Number: CDS984241L, UPC Number: 019348996186; Model Number: CDS984241M, UPC Number: 019532716563.   nnnn. Model Number: DYNJ63892A, UPC Number: 019532717651.   oooo. Model Number: DYNJ62735, UPC Number: 019348968528.   pppp. Model Number: 00-401185Q, UPC Number: 019348948908.   qqqq. Model Number: DYNJ52056C, UPC Number: 019348936944; Model Number: DYNJ52056D, UPC Number: 019532709613.   rrrr. Model Number: DYNJ904261B, UPC Number: 019348947953; Model Number: DYNJ905311D, UPC Number: 019348926126; Model Number: DYNJ906760C, UPC Number: 019348999431; Model Number: DYNJ906760D, UPC Number: 019532724695; Model Number: DYNJ9718008AS, UPC Number: 019348926312; Model Number: CDS981161AC, UPC Number: 019532727643.     ssss. Model Number: CDS985105N, UPC Number: 019348990229; Model Number: CDS985105O, UPC Number: 019532703624.   tttt. Model Number: DYNJ0450131AI, UPC Number: 019348946612.   uuuu. Model Number: DYNJ20888K, UPC Number: 019532736012.   vvvv. Model Number: DYNJ23533B, UPC Number: 019348956435; Model Number: DYNJ23533D, UPC Number: 019348947065.   wwww. Model Number: CDS983849D, UPC Number: 019348927823, Model Number: CDS983849F, UPC Number: 019532722831.   xxxx. Model Number: DYNJ55836A, UPC Number: 019348955285.   yyyy. Model Number: DYNJ0149567B, UPC Number: 088827773796; Model Number: DYNJ0149567C, UPC Number: 019532723552.   zzzz. Model Number: CDS983513F, UPC Number: 019348984372; Model Number: CDS984355F, UPC Number: 088827777034; Model Number: CDS984355G, UPC Number: 019348948463; Model Number: DYNJ905311F, UPC Number: 019348990224; Model Number: DYNJ905311I, UPC Number: 019532714621; Model Number: DYNJ907607A, UPC Number: 019348987340; Model Number: DYNJ907607B, UPC Number: 019532717419.. 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-2301-2023&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-2301-2023&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-2301-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2301-2023 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-2301-2023&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-2301-2023&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-2301-2023/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-2301-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2301-2023",
            "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 - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-15",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
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Model Number: CDS983394I, UPC Number: 019348981995; Model Number: CDS983394J, UPC Number: 019532706987; Model Number: CDS983394K, UPC Number: 019532729258.  i. Model Number: DYNJVB91067, UPC Number: 019348980153.   j. Model Number: DYNJ906354D, UPC Number: 019348998657; Model Number: DYNJ906354F, UPC Number: 019532702150.  k. Model Number: DYNJ0678934I, UPC Number: 019348999786; Model Number: DYNJ44934F, UPC Number: 019348944613; Model Number: DYNJ905726C, UPC Number: 019348994337; Model Number: DYNJ905726D, UPC Number: 019532716151.  l. Model Number: DYNJ42831F, UPC Number: 019348988032.  m. Model Number: DYNJ67750, UPC Number: 019348942917, Model Number: DYNJ67750A, UPC Number: 019348983224, Model Number: DYNJ67750B, UPC Number: 019348991204, Model Number: DYNJ67750C, UPC Number: 019532734136.  n. Model Number: DYNJ80489, UPC Number: 019532704584.   o. Model Number: DYNJ48456C, UPC Number: 019532701586; Model Number: DYNJ69108A, UPC Number: 019532702571.   p. Model Number: DYNJ83606, UPC Number: 019532728485.  q. Model Number: SYNJ910018B, UPC Number: 019532700730.  r. Model Number: DYNJ25749S, UPC Number: 019532705970.  s. Model Number: DYNJ47645C, UPC Number: 019532735517.  t. Model Number: DYNJ59392D, UPC Number: 019532705357; Model Number: DYNJ59392F, UPC Number: 019532713598.  u. Model Number: DYNJ67770, UPC Number: 019348943071.  v. Model Number: DYNJ23456K, UPC Number: 019348996776; Model Number: DYNJ68019, UPC Number: 019348946784; Model Number: DYNJ81716, UPC Number: 019532713806;  Model Number: DYNJ81716A, UPC Number: 019532720385; Model Number: DYNJ81716B, UPC Number: 019532727726.  w. Model Number: DYNJ67771, UPC Number: 019348943072.  x. Model Number: DYNJ31928D, UPC Number: 019532733528.  y. Model Number: DYNJ53480F, UPC Number: 019348942488.  z. Model Number: DYNJ67487C, UPC Number: 019532726074.  aa. Model Number: DYNJ82711, UPC Number: 019532720362.  bb. Model Number: DYNJ69943A, UPC Number: 019532728463.  cc. Model Number: DYNJ907915, UPC Number: 019348994368.  dd. Model Number: CDS984193O, UPC Number: 019348937708.  ee. Model Number: DYNJ46590I, UPC Number: 019348975763; Model Number: DYNJ46590J, UPC Number: 019348947369; Model Number: DYNJ46590K, UPC Number: 019532709400.  ff. Model Number: DYNJ68198, UPC Number: 019348949917.  gg. Model Number: DYNJ51925F, UPC Number: 019532715339.  hh. Model Number: DYNJ0541930N, UPC Number: 019348971892.   ii. Model Number: DYNJ64877B, UPC Number: 019348941589.   jj. Model Number: DYNJ55528A, UPC Number: 088994297663; Model Number: DYNJ55528B, UPC Number: 019532704649; Model Number: DYNJ55528C, UPC Number: 019532724820.  kk. Model Number: DYNJ48424A, UPC Number: 088827792129.  ll. Model Number: DYNJ58365C, UPC Number: 019348945985; Model Number: DYNJ58365F, UPC Number: 019348982057; Model Number: DYNJ58365G, UPC Number: 019348988393; Model Number: DYNJ58365J, UPC Number: 019532701909.  mm. Model Number: DYNJ62851B, UPC Number: 019348927121.  nn. Model Number: DYNJ62850A, UPC Number: 019348978423.  oo. Model Number: DYNJ905495D, UPC Number: 019348983924; Model Number: DYNJ905495F, UPC Number: 019348992493.  pp. Model Number: DYNJ38756B, UPC Number: 019348956435.  qq. Model Number: DYNJ907571A, UPC Number: 019348992612; Model Number: DYNJ907571B, UPC Number: 019532726241.  rr. Model Number: DYNJ40215C, UPC Number: 019532717650.  ss. Model Number: DYNJ52756A, UPC Number: 019348941383.   tt. Model Number: DYNJ47138B, UPC Number: 088994227421.  uu. Model Number: DYNJ82858A, UPC Number: 019532724489.  vv. Model Number: DYNJ82859A, UPC Number: 019532724490.  ww. Model Number: DYNJ66076, UPC Number: 019348931923.  xx. Model Number: DYKMBNDL22C, UPC Number: 019532724096.  yy. Model Number: CDS840487G, UPC Number: 019348967442.  zz. Model Number: DYNJ907262, UPC Number: 019348938515, Model Number: DYNJ907262B, UPC Number: 019532711641.  aaa. Model Number: DYKMBNDL148A, UPC Number: 019532724129.  bbb. Model Number: DYNJ906113, UPC Number: 019348965872.  ccc. Model Number: DYNJ906086B, UPC Number: 019532704635.  ddd. Model Number: DYKMBNDL23, UPC Number: 019348947918.  eee. Model Number: DYNJ906098, UPC Number: 019348963877; Model Number: DYNJ906098A, UPC Number: 019348920945.  fff. Model Number: DYKMBNDL118A, UPC Number: 019532724067.  ggg. Model Number: DYNJ906960A, UPC Number: 019532700259.  hhh.  Model Number: DYNJ56283C, UPC Number: 019348926872; Model Number: DYNJ56283D, UPC Number: 019532709387; Model Number: DYNJ56283F, UPC Number: 019532721185.  iii. Model Number: DYNJ48962B, UPC Number: 088994212967.  jjj. Model Number: DYNJ38995C, UPC Number: 019348971314, Model Number: DYNJ67725, UPC Number: 019348942584.   kkk. Model Number: DYNJ65294, UPC Number: 019348926426.  lll. Model Number: DYNJ905859B, UPC Number: 019348941786.  mmm. Model Number: DYNJ54906B, UPC Number: 019348928963.  nnn. Model Number: DYNJ905626B, UPC Number: 019348963423.  ooo. Model Number: DYNJ81407, UPC Number: 019532711766.  ppp. Model Number: DYNJ41100C, UPC Number: 019348989982.  qqq. Model Number: DYNJ0678934G, UPC Number: 019348956435.  rrr. Model Number: DYNJ902168C, UPC Number: 019348945421.    sss. Model Number: DYNJ908687, UPC Number: 019532714092.  ttt. Model Number: DYNJ61373, UPC Number: 019348957669.  uuu. Model Number: DYNJ901062D, UPC Number: 019348921181; Model Number: DYNJ905641, UPC Number: 019348952766; Model Number: DYNJ905641A, UPC Number: 019532703927; Model Number: DYNJ906371B, UPC Number: 019348981669; Model Number: DYNJ906371C, UPC Number: 019532702146; Model Number: DYNJ906951, UPC Number: 019348929999; Model Number: DYNJ906951A, UPC Number: 019532712835; Model Number: DYNJ908390, UPC Number: 019532708832.  vvv. Model Number: CDS840368M, UPC Number: 019348949162; Model Number: CDS840368N, UPC Number: 019532702036; Model Number: CDS840368P, UPC Number: 019532732286.  www. Model Number: DYNJ45515D, UPC Number: 019348936735; Model Number: DYNJ81610A, UPC Number: 019532731504.  xxx. Model Number: DYNJC9307F, UPC Number: 019348926312; Model Number: DYNJC9307G, UPC Number: 019532703329.  yyy. Model Number: DYNJ82988, UPC Number: 019532722220; Model Number: DYNJ82988A, UPC Number: 019532729331.  zzz. Model Number: DYNJ82987, UPC Number: 019532722211.   aaaa. Model Number: DYNJ0622403O, UPC Number: 088994221921.   bbbb. Model Number: DYNJ66916A, UPC Number: 019348999322.   cccc. Model Number: DYNJ903705I, UPC Number: 019348997955.   dddd. Model Number: DYNJ903706K, UPC Number: 019348999413.   eeee. Model Number: DYNJ53433G, UPC Number: 019532704243; Model Number: DYNJ53433I, UPC Number: 019532707449; Model Number: DYNJ53433J, UPC Number: 019532722292.   ffff. Model Number: DYNJ44122B, UPC Number: 019348923136.   gggg.Model Number: DYNJ904171D, UPC Number: 019348945094; Model Number: DYNJ904171F, UPC Number: 019348943924; Model Number: DYNJ907063A, UPC Number: 019348983381; Model Number: DYNJ908391, UPC Number: 019532708831.   hhhh. Model Number: DYNJ60713, UPC Number: 019348952003; Model Number: DYNJ60713A, UPC Number: 019532701206; Model Number: DYNJ68616, UPC Number: 019348983858; Model Number: DYNJ69036, UPC Number: 019348988394.   iiii. Model Number: DYNJ0349727D, UPC Number: 019532700015.   jjjj. Model Number: DYNJ31148I, UPC Number: 019348956435.   kkkk. Model Number: DYNJ61584A, UPC Number: 019348981281.   llll. Model Number: CDS984231T, UPC Number: 019348962640.   mmmm. Model Number: CDS984241L, UPC Number: 019348996186; Model Number: CDS984241M, UPC Number: 019532716563.   nnnn. Model Number: DYNJ63892A, UPC Number: 019532717651.   oooo. Model Number: DYNJ62735, UPC Number: 019348968528.   pppp. Model Number: 00-401185Q, UPC Number: 019348948908.   qqqq. Model Number: DYNJ52056C, UPC Number: 019348936944; Model Number: DYNJ52056D, UPC Number: 019532709613.   rrrr. Model Number: DYNJ904261B, UPC Number: 019348947953; Model Number: DYNJ905311D, UPC Number: 019348926126; Model Number: DYNJ906760C, UPC Number: 019348999431; Model Number: DYNJ906760D, UPC Number: 019532724695; Model Number: DYNJ9718008AS, UPC Number: 019348926312; Model Number: CDS981161AC, UPC Number: 019532727643.     ssss. Model Number: CDS985105N, UPC Number: 019348990229; Model Number: CDS985105O, UPC Number: 019532703624.   tttt. Model Number: DYNJ0450131AI, UPC Number: 019348946612.   uuuu. Model Number: DYNJ20888K, UPC Number: 019532736012.   vvvv. Model Number: DYNJ23533B, UPC Number: 019348956435; Model Number: DYNJ23533D, UPC Number: 019348947065.   wwww. Model Number: CDS983849D, UPC Number: 019348927823, Model Number: CDS983849F, UPC Number: 019532722831.   xxxx. Model Number: DYNJ55836A, UPC Number: 019348955285.   yyyy. Model Number: DYNJ0149567B, UPC Number: 088827773796; Model Number: DYNJ0149567C, UPC Number: 019532723552.   zzzz. Model Number: CDS983513F, UPC Number: 019348984372; Model Number: CDS984355F, UPC Number: 088827777034; Model Number: CDS984355G, UPC Number: 019348948463; Model Number: DYNJ905311F, UPC Number: 019348990224; Model Number: DYNJ905311I, UPC Number: 019532714621; Model Number: DYNJ907607A, UPC Number: 019348987340; Model Number: DYNJ907607B, UPC Number: 019532717419.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}