{
  "@context": {
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    "occurred": "au:occurred",
    "supported": "au:supported",
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    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
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    "falsifier": "au:falsifier"
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0513-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "MEDLINE convenience kits labeled as:    1) GENERAL AAA #11-RF, REF CDS840261AB;   2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I;   3) PERIPHERAL VASCULAR CDS, REF CDS983723J;   4) ACH OPEN HEART, REF CDS983773J;   5) VASCULAR, REF CDS984255K;   6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C;   7) VASCULAR PACK-LF, REF DYNJ0421380P;   8) GEN FEM POP #14-RF, REF DYNJ21877W;   9) VASCULAR PACK, REF DYNJ22350L;   10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC;   11) OPEN HEART PACK, REF DYNJ37284K;   12) ACH CABG ADD-ON, REF DYNJ38175L;   13) CARDIOVASCULAR PACK, REF DYNJ42921G;   14) CABG PACK-LF, REF DYNJ43207K;   15) HEART DRAPING PACK-LF, REF DYNJ43214F;   16) AAA PACK, REF DYNJ44847I;   17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U;   18) FISTULA PACK, REF DYNJ44869K;   19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K;   20) PERMANENT PACING, REF DYNJ44886M;   21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M;   22) DR DANIELSON AC PACK, REF DYNJ51038R;   23) VASCULAR CAROTID PACK, REF DYNJ56838F;   24) VASCULAR FEM PACK, REF DYNJ56839D;   25) PK CUST OPEN HEART A AND B, REF DYNJ60548B;   26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B;   27) CAROTID PACK, REF DYNJ61659A;   28) VASCULAR MINOR PACK, REF DYNJ62097C;   29) VASCULAR PACK-LF, REF DYNJ65039C;   30) PACEMAKER PACK, REF DYNJ66033B;   31) DR MELLINGER AC PACK, REF DYNJ80609D;   32) HEART PACK II, REF DYNJ81581B;   33) AV FISTULA PACK, REF DYNJ81605;   34) MAJOR VASCULAR PACK, REF DYNJ81610B;   35) CABG ACCESSORY PACK, REF DYNJ82166;   36) VALVE ACCESSORY PACK, REF DYNJ82217;   37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B;   38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109;   39) ACH OPEN HEART A&B PK, REF DYNJ85110;   40) VASCULAR ABDOMINAL PACK, REF DYNJ85118;   41) AV FISTULA PACK-LF, REF DYNJ85121;   42) CARDIAC - DEEIK PACK, REF DYNJ85637;   43) VASCULAR, REF DYNJ900293K;   44) VASCULAR-LF, REF DYNJ900714C;   45) HEART/MAJOR VASCULAR, REF DYNJ901066K;   46) MODULE OPEN HEART, REF DYNJ903042P;   47) VASCULAR/OR ANGIO, REF DYNJ905079F;   48) OPEN HEART, REF DYNJ905497B;   49) AAA, REF DYNJ906175B;   50) VASCULAR ABDOMINAL, REF DYNJ907105D;   51) CV COMPLETE, REF DYNJ907904A;   52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820;   53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A.",
  "description": "FDA recall Z-0513-2026 — Medline Industries, LP is recalling MEDLINE convenience kits labeled as:    1) GENERAL AAA #11-RF, REF CDS840261AB;   2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I;   3) PERIPHERAL VASCULAR CDS, REF CDS983723J;   4) ACH OPEN HEART, REF CDS983773J;   5) VASCULAR, REF CDS984255K;   6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C;   7) VASCULAR PACK-LF, REF DYNJ0421380P;   8) GEN FEM POP #14-RF, REF DYNJ21877W;   9) VASCULAR PACK, REF DYNJ22350L;   10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC;   11) OPEN HEART PACK, REF DYNJ37284K;   12) ACH CABG ADD-ON, REF DYNJ38175L;   13) CARDIOVASCULAR PACK, REF DYNJ42921G;   14) CABG PACK-LF, REF DYNJ43207K;   15) HEART DRAPING PACK-LF, REF DYNJ43214F;   16) AAA PACK, REF DYNJ44847I;   17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U;   18) FISTULA PACK, REF DYNJ44869K;   19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K;   20) PERMANENT PACING, REF DYNJ44886M;   21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M;   22) DR DANIELSON AC PACK, REF DYNJ51038R;   23) VASCULAR CAROTID PACK, REF DYNJ56838F;   24) VASCULAR FEM PACK, REF DYNJ56839D;   25) PK CUST OPEN HEART A AND B, REF DYNJ60548B;   26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B;   27) CAROTID PACK, REF DYNJ61659A;   28) VASCULAR MINOR PACK, REF DYNJ62097C;   29) VASCULAR PACK-LF, REF DYNJ65039C;   30) PACEMAKER PACK, REF DYNJ66033B;   31) DR MELLINGER AC PACK, REF DYNJ80609D;   32) HEART PACK II, REF DYNJ81581B;   33) AV FISTULA PACK, REF DYNJ81605;   34) MAJOR VASCULAR PACK, REF DYNJ81610B;   35) CABG ACCESSORY PACK, REF DYNJ82166;   36) VALVE ACCESSORY PACK, REF DYNJ82217;   37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B;   38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109;   39) ACH OPEN HEART A&B PK, REF DYNJ85110;   40) VASCULAR ABDOMINAL PACK, REF DYNJ85118;   41) AV FISTULA PACK-LF, REF DYNJ85121;   42) CARDIAC - DEEIK PACK, REF DYNJ85637;   43) VASCULAR, REF DYNJ900293K;   44) VASCULAR-LF, REF DYNJ900714C;   45) HEART/MAJOR VASCULAR, REF DYNJ901066K;   46) MODULE OPEN HEART, REF DYNJ903042P;   47) VASCULAR/OR ANGIO, REF DYNJ905079F;   48) OPEN HEART, REF DYNJ905497B;   49) AAA, REF DYNJ906175B;   50) VASCULAR ABDOMINAL, REF DYNJ907105D;   51) CV COMPLETE, REF DYNJ907904A;   52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820;   53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A. (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-0513-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MEDLINE convenience kits labeled as:    1) GENERAL AAA #11-RF, REF CDS840261AB;   2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I;   3) PERIPHERAL VASCULAR CDS, REF CDS983723J;   4) ACH OPEN HEART, REF CDS983773J;   5) VASCULAR, REF CDS984255K;   6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C;   7) VASCULAR PACK-LF, REF DYNJ0421380P;   8) GEN FEM POP #14-RF, REF DYNJ21877W;   9) VASCULAR PACK, REF DYNJ22350L;   10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC;   11) OPEN HEART PACK, REF DYNJ37284K;   12) ACH CABG ADD-ON, REF DYNJ38175L;   13) CARDIOVASCULAR PACK, REF DYNJ42921G;   14) CABG PACK-LF, REF DYNJ43207K;   15) HEART DRAPING PACK-LF, REF DYNJ43214F;   16) AAA PACK, REF DYNJ44847I;   17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U;   18) FISTULA PACK, REF DYNJ44869K;   19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K;   20) PERMANENT PACING, REF DYNJ44886M;   21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M;   22) DR DANIELSON AC PACK, REF DYNJ51038R;   23) VASCULAR CAROTID PACK, REF DYNJ56838F;   24) VASCULAR FEM PACK, REF DYNJ56839D;   25) PK CUST OPEN HEART A AND B, REF DYNJ60548B;   26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B;   27) CAROTID PACK, REF DYNJ61659A;   28) VASCULAR MINOR PACK, REF DYNJ62097C;   29) VASCULAR PACK-LF, REF DYNJ65039C;   30) PACEMAKER PACK, REF DYNJ66033B;   31) DR MELLINGER AC PACK, REF DYNJ80609D;   32) HEART PACK II, REF DYNJ81581B;   33) AV FISTULA PACK, REF DYNJ81605;   34) MAJOR VASCULAR PACK, REF DYNJ81610B;   35) CABG ACCESSORY PACK, REF DYNJ82166;   36) VALVE ACCESSORY PACK, REF DYNJ82217;   37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B;   38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109;   39) ACH OPEN HEART A&B PK, REF DYNJ85110;   40) VASCULAR ABDOMINAL PACK, REF DYNJ85118;   41) AV FISTULA PACK-LF, REF DYNJ85121;   42) CARDIAC - DEEIK PACK, REF DYNJ85637;   43) VASCULAR, REF DYNJ900293K;   44) VASCULAR-LF, REF DYNJ900714C;   45) HEART/MAJOR VASCULAR, REF DYNJ901066K;   46) MODULE OPEN HEART, REF DYNJ903042P;   47) VASCULAR/OR ANGIO, REF DYNJ905079F;   48) OPEN HEART, REF DYNJ905497B;   49) AAA, REF DYNJ906175B;   50) VASCULAR ABDOMINAL, REF DYNJ907105D;   51) CV COMPLETE, REF DYNJ907904A;   52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820;   53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0513-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0513-2026: Medline Industries, LP is recalling MEDLINE convenience kits labeled as:    1) GENERAL AAA #11-RF, REF CDS840261AB;   2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I;   3) PERIPHERAL VASCULAR CDS, REF CDS983723J;   4) ACH OPEN HEART, REF CDS983773J;   5) VASCULAR, REF CDS984255K;   6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C;   7) VASCULAR PACK-LF, REF DYNJ0421380P;   8) GEN FEM POP #14-RF, REF DYNJ21877W;   9) VASCULAR PACK, REF DYNJ22350L;   10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC;   11) OPEN HEART PACK, REF DYNJ37284K;   12) ACH CABG ADD-ON, REF DYNJ38175L;   13) CARDIOVASCULAR PACK, REF DYNJ42921G;   14) CABG PACK-LF, REF DYNJ43207K;   15) HEART DRAPING PACK-LF, REF DYNJ43214F;   16) AAA PACK, REF DYNJ44847I;   17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U;   18) FISTULA PACK, REF DYNJ44869K;   19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K;   20) PERMANENT PACING, REF DYNJ44886M;   21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M;   22) DR DANIELSON AC PACK, REF DYNJ51038R;   23) VASCULAR CAROTID PACK, REF DYNJ56838F;   24) VASCULAR FEM PACK, REF DYNJ56839D;   25) PK CUST OPEN HEART A AND B, REF DYNJ60548B;   26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B;   27) CAROTID PACK, REF DYNJ61659A;   28) VASCULAR MINOR PACK, REF DYNJ62097C;   29) VASCULAR PACK-LF, REF DYNJ65039C;   30) PACEMAKER PACK, REF DYNJ66033B;   31) DR MELLINGER AC PACK, REF DYNJ80609D;   32) HEART PACK II, REF DYNJ81581B;   33) AV FISTULA PACK, REF DYNJ81605;   34) MAJOR VASCULAR PACK, REF DYNJ81610B;   35) CABG ACCESSORY PACK, REF DYNJ82166;   36) VALVE ACCESSORY PACK, REF DYNJ82217;   37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B;   38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109;   39) ACH OPEN HEART A&B PK, REF DYNJ85110;   40) VASCULAR ABDOMINAL PACK, REF DYNJ85118;   41) AV FISTULA PACK-LF, REF DYNJ85121;   42) CARDIAC - DEEIK PACK, REF DYNJ85637;   43) VASCULAR, REF DYNJ900293K;   44) VASCULAR-LF, REF DYNJ900714C;   45) HEART/MAJOR VASCULAR, REF DYNJ901066K;   46) MODULE OPEN HEART, REF DYNJ903042P;   47) VASCULAR/OR ANGIO, REF DYNJ905079F;   48) OPEN HEART, REF DYNJ905497B;   49) AAA, REF DYNJ906175B;   50) VASCULAR ABDOMINAL, REF DYNJ907105D;   51) CV COMPLETE, REF DYNJ907904A;   52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820;   53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A.",
      "text": "The FDA logged enforcement record Z-0513-2026: Medline Industries, LP is voluntarily recalling MEDLINE convenience kits labeled as:    1) GENERAL AAA #11-RF, REF CDS840261AB;   2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I;   3) PERIPHERAL VASCULAR CDS, REF CDS983723J;   4) ACH OPEN HEART, REF CDS983773J;   5) VASCULAR, REF CDS984255K;   6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C;   7) VASCULAR PACK-LF, REF DYNJ0421380P;   8) GEN FEM POP #14-RF, REF DYNJ21877W;   9) VASCULAR PACK, REF DYNJ22350L;   10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC;   11) OPEN HEART PACK, REF DYNJ37284K;   12) ACH CABG ADD-ON, REF DYNJ38175L;   13) CARDIOVASCULAR PACK, REF DYNJ42921G;   14) CABG PACK-LF, REF DYNJ43207K;   15) HEART DRAPING PACK-LF, REF DYNJ43214F;   16) AAA PACK, REF DYNJ44847I;   17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U;   18) FISTULA PACK, REF DYNJ44869K;   19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K;   20) PERMANENT PACING, REF DYNJ44886M;   21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M;   22) DR DANIELSON AC PACK, REF DYNJ51038R;   23) VASCULAR CAROTID PACK, REF DYNJ56838F;   24) VASCULAR FEM PACK, REF DYNJ56839D;   25) PK CUST OPEN HEART A AND B, REF DYNJ60548B;   26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B;   27) CAROTID PACK, REF DYNJ61659A;   28) VASCULAR MINOR PACK, REF DYNJ62097C;   29) VASCULAR PACK-LF, REF DYNJ65039C;   30) PACEMAKER PACK, REF DYNJ66033B;   31) DR MELLINGER AC PACK, REF DYNJ80609D;   32) HEART PACK II, REF DYNJ81581B;   33) AV FISTULA PACK, REF DYNJ81605;   34) MAJOR VASCULAR PACK, REF DYNJ81610B;   35) CABG ACCESSORY PACK, REF DYNJ82166;   36) VALVE ACCESSORY PACK, REF DYNJ82217;   37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B;   38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109;   39) ACH OPEN HEART A&B PK, REF DYNJ85110;   40) VASCULAR ABDOMINAL PACK, REF DYNJ85118;   41) AV FISTULA PACK-LF, REF DYNJ85121;   42) CARDIAC - DEEIK PACK, REF DYNJ85637;   43) VASCULAR, REF DYNJ900293K;   44) VASCULAR-LF, REF DYNJ900714C;   45) HEART/MAJOR VASCULAR, REF DYNJ901066K;   46) MODULE OPEN HEART, REF DYNJ903042P;   47) VASCULAR/OR ANGIO, REF DYNJ905079F;   48) OPEN HEART, REF DYNJ905497B;   49) AAA, REF DYNJ906175B;   50) VASCULAR ABDOMINAL, REF DYNJ907105D;   51) CV COMPLETE, REF DYNJ907904A;   52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820;   53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A. — reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-30. Affected lots/codes: 1) CDS840261AB:  UDI/DI 10195327104535 (each), 40195327104536 (case),  Lot Numbers:   23FBF165, 23JBM632.     2) CDS983637I:  UDI/DI 10195327228125 (each), 40195327228126 (case),  Lot Numbers:  23GBU191.     3) CDS983723J:  UDI/DI 10195327327828 (each), 40195327327829 (case),  Lot Numbers:  23FBA013, 23FBH486, 23GBE805.      4) CDS983773J:  UDI/DI 10195327233617 (each), 40195327233618 (case),  Lot Numbers:  23GBT133, 23HBH924, 23HBL135, 23HBV936.      5) CDS984255K:  UDI/DI 10193489288605 (each), 40193489288606 (case),  Lot Numbers:  23KBU348, 24ABB883, 24ABS338.      6) DYNJ0161262C:  UDI/DI 10195327357283 (each), 40195327357284 (case),  Lot Numbers:  23GDB197, 23GDB757.    7) DYNJ0421380P:  UDI/DI 10195327084271 (each), 40195327084272 (case),  Lot Numbers:  23DMI590, 23FMJ656.    8) DYNJ21877W:  UDI/DI 10195327104542 (each), 40195327104543 (case),  Lot Numbers:  23FBT682, 23GBF898, 23IBC645, 24ABR316.      9) DYNJ22350L:  UDI/DI 10193489445251 (each), 40193489445252 (case),  Lot Numbers:  23LBU055, 24BBQ300.      10) DYNJ27432AC:  UDI/DI 10195327104511 (each), 40195327104512 (case),  Lot Numbers:  23EBU150, 23GBF873, 23HBQ650, 23IBB637.    11) DYNJ37284K:  UDI/DI 10195327401030 (each), 40195327401031 (case),  Lot Numbers:   23IBP124, 23KBF938, 24ABS487.    12) DYNJ38175L:  UDI/DI 10195327227906 (each), 40195327227907 (case),  Lot Numbers:  23FLA915, 23ILA168.     13) DYNJ42921G:  UDI/DI 10193489981384 (each), 40193489981385 (case),  Lot Numbers:  23FBU282, 23IBT172.          14) DYNJ43207K:  UDI/DI 10193489952926 (each), 40193489952927 (case),  Lot Numbers:  23EME962.     15) DYNJ43214F:  UDI/DI 10193489953077 (each), 40193489953078 (case),  Lot Numbers:  23EMA158.      16) DYNJ44847I:  UDI/DI 10195327127558 (each), 40195327127559 (case),  Lot Numbers: 23HLA758, 23HLB101, 23LLA759.     17) DYNJ44857U:  UDI/DI 10195327298067 (each), 40195327298068 (case),  Lot Numbers:  23GBI967, 23GBQ950.     18) DYNJ44869K:  UDI/DI 10195327127657 (each), 40195327127658 (case),  Lot Numbers:   23GBI967, 23GBQ950, 23KMC104.     19) DYNJ44879K:  UDI/DI 10195327282233 (each), 40195327282234 (case),  Lot Numbers:   23DBI854, 23EBH319, 23GBT541.     20) DYNJ44886M:  UDI/DI 10195327127749 (each), 40195327127740 (case),  Lot Numbers:  23DBN895, 23EBU129, 23FBQ134, 23GBQ953, 23HBT951.      21) DYNJ50528M:  UDI/DI 10195327129699 (each), 40195327129690 (case),  Lot Numbers:  23EBA780, 23EBS770, 23GBT274.      22) DYNJ51038R:  UDI/DI 10195327298258 (each), 40195327298259 (case),  Lot Numbers:  23HBD834.      23) DYNJ56838F:  UDI/DI 10195327277857 (each), 40195327277858 (case),  Lot Numbers:  23GDA228, 23HDA839.      24) DYNJ56839D:  UDI/DI 10195327277864 (each), 40195327277865 (case),  Lot Numbers:  23GDA320.      25) DYNJ60548B:  UDI/DI 10195327361761 (each), 40195327361762 (case),  Lot Numbers:  23EBD777, 23IBS545, 23JBJ740.     26) DYNJ60783B:  UDI/DI 10195327361846 (each), 40195327361847 (case),  Lot Numbers :  23EBR616, 23GBW384, 23IBV398.    27) DYNJ61659A:  UDI/DI 10193489929638 (each), 40193489929639 (case),  Lot Numbers:  23HBI627.     28) DYNJ62097C:  UDI/DI 10195327189839 (each), 40195327189830 (case),  Lot Numbers:  23DBJ117, 23EBD473, 23HBQ663, 23IBB641.    29) DYNJ65039C:  UDI/DI 10195327528256 (each), 40195327528257 (case),  Lot Numbers:  24BMF955, 24CMB409, 24CME382, 24FMH176.      30) DYNJ66033B:  UDI/DI 10195327680589 (each), 40195327680580 (case),  Lot Numbers:  24EBA176.     31) DYNJ80609D:  UDI/DI 10195327298296 (each), 40195327298297 (case),  Lot Numbers:  23HBR318, 23HBZ183.      32) DYNJ81581B:  UDI/DI 10195327379254 (each), 40195327379255 (case),  Lot Numbers: 23EBO537, 23GBQ499, 23HBG425.        33) DYNJ81605:  UDI/DI 10195327123888 (each), 40195327123889 (case),  Lot Numbers:  23DBL829, 23EBI374, 23EBM656.     34) DYNJ81610B:  UDI/DI 10195327398316 (each), 40195327398317 (case),  Lot Numbers:   23EBA748, 23IBP506.     35) DYNJ82166:  UDI/DI 10195327182564 (each), 40195327182565 (case),  Lot Numbers:  23FDA955.      36) DYNJ82217:  UDI/DI 10195327183585 (each), 40195327183586 (case),  Lot Numbers:  23DDB931, 23HDA667.      37) DYNJ84017B:  UDI/DI 10198459253089 (each), 40198459253080 (case),  Lot Numbers:  25CMF132.      38) DYNJ85109:  UDI/DI 10195327460594 (each), 40195327460595 (case),  Lot Numbers:  23JBD986.    39) DYNJ85110:  UDI/DI 10195327460792 (each), 40195327460793 (case),  Lot Numbers: 23KBF140.     40) DYNJ85118:  UDI/DI 10195327460730 (each), 40195327460731 (case),  Lot Numbers: 23KBI277.     41) DYNJ85121:  UDI/DI 10195327460853 (each), 40195327460854 (case),  Lot Numbers:  23IBR236, 23JBC564.    42) DYNJ85637:  UDI/DI 10195327528188 (each), 40195327528189 (case),  Lot Numbers: 24CBL150.     43) DYNJ900293K:  UDI/DI 10195327554064 (each), 40195327554065 (case),  Lot Numbers:  24ABE610, 24BBT270, 24DBU219.     44) DYNJ900714C:  UDI/DI 10193489951363 (each), 40193489951364 (case),  Lot Numbers:  23FBL767, 23HBW562, 23JBF697.    45) DYNJ901066K:  UDI/DI 10195327239282 (each), 40195327239283 (case),  Lot Numbers:  23HBB464, 23HBC020, 23JBF553, 23JBW634.    46) DYNJ903042P:  UDI/DI 10195327438388 (each), 40195327438389 (case),  Lot Numbers:  23JBL424, 23LBL094, 24ABS138.    47) DYNJ905079F:  UDI/DI 10195327209001 (each), 40195327209002 (case),  Lot Numbers:  23GBV464, 23HBO354.    48) DYNJ905497B:  UDI/DI 10193489951639 (each), 40193489951630 (case),  Lot Numbers:  23GBB505, 23HBN192, 23JBV542, 23JBV684.    49) DYNJ906175B:  UDI/DI 10195327480127 (each), 40195327480128 (case),  Lot Numbers:  24FMI570.    50) DYNJ907105D:  UDI/DI 10195327233624 (each), 40195327233625 (case),  Lot Numbers:  23EBG144, 23EBT013, 23FBI805, 23FBQ992.    51) DYNJ907904A:  UDI/DI 10193489992434 (each), 40193489992435 (case),  Lot Numbers:  23JME513, 23KMD522.    52) DYNJ908820:  UDI/DI 10195327185671 (each), 40195327185672 (case),  Lot Numbers:  23JMG465, 23KMI460.     53) DYNJ908820A:  UDI/DI 10195327546045 (each), 40195327546046 (case),  Lot Numbers:  23LMH559, 24CMA145, 24DMF994, 24DMI666.. 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-0513-2026&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-0513-2026&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-0513-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0513-2026 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-0513-2026&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-0513-2026&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-0513-2026/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-0513-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0513-2026",
            "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": "Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-09-30",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) CDS840261AB:  UDI/DI 10195327104535 (each), 40195327104536 (case),  Lot Numbers:   23FBF165, 23JBM632.     2) CDS983637I:  UDI/DI 10195327228125 (each), 40195327228126 (case),  Lot Numbers:  23GBU191.     3) CDS983723J:  UDI/DI 10195327327828 (each), 40195327327829 (case),  Lot Numbers:  23FBA013, 23FBH486, 23GBE805.      4) CDS983773J:  UDI/DI 10195327233617 (each), 40195327233618 (case),  Lot Numbers:  23GBT133, 23HBH924, 23HBL135, 23HBV936.      5) CDS984255K:  UDI/DI 10193489288605 (each), 40193489288606 (case),  Lot Numbers:  23KBU348, 24ABB883, 24ABS338.      6) DYNJ0161262C:  UDI/DI 10195327357283 (each), 40195327357284 (case),  Lot Numbers:  23GDB197, 23GDB757.    7) DYNJ0421380P:  UDI/DI 10195327084271 (each), 40195327084272 (case),  Lot Numbers:  23DMI590, 23FMJ656.    8) DYNJ21877W:  UDI/DI 10195327104542 (each), 40195327104543 (case),  Lot Numbers:  23FBT682, 23GBF898, 23IBC645, 24ABR316.      9) DYNJ22350L:  UDI/DI 10193489445251 (each), 40193489445252 (case),  Lot Numbers:  23LBU055, 24BBQ300.      10) DYNJ27432AC:  UDI/DI 10195327104511 (each), 40195327104512 (case),  Lot Numbers:  23EBU150, 23GBF873, 23HBQ650, 23IBB637.    11) DYNJ37284K:  UDI/DI 10195327401030 (each), 40195327401031 (case),  Lot Numbers:   23IBP124, 23KBF938, 24ABS487.    12) DYNJ38175L:  UDI/DI 10195327227906 (each), 40195327227907 (case),  Lot Numbers:  23FLA915, 23ILA168.     13) DYNJ42921G:  UDI/DI 10193489981384 (each), 40193489981385 (case),  Lot Numbers:  23FBU282, 23IBT172.          14) DYNJ43207K:  UDI/DI 10193489952926 (each), 40193489952927 (case),  Lot Numbers:  23EME962.     15) DYNJ43214F:  UDI/DI 10193489953077 (each), 40193489953078 (case),  Lot Numbers:  23EMA158.      16) DYNJ44847I:  UDI/DI 10195327127558 (each), 40195327127559 (case),  Lot Numbers: 23HLA758, 23HLB101, 23LLA759.     17) DYNJ44857U:  UDI/DI 10195327298067 (each), 40195327298068 (case),  Lot Numbers:  23GBI967, 23GBQ950.     18) DYNJ44869K:  UDI/DI 10195327127657 (each), 40195327127658 (case),  Lot Numbers:   23GBI967, 23GBQ950, 23KMC104.     19) DYNJ44879K:  UDI/DI 10195327282233 (each), 40195327282234 (case),  Lot Numbers:   23DBI854, 23EBH319, 23GBT541.     20) DYNJ44886M:  UDI/DI 10195327127749 (each), 40195327127740 (case),  Lot Numbers:  23DBN895, 23EBU129, 23FBQ134, 23GBQ953, 23HBT951.      21) DYNJ50528M:  UDI/DI 10195327129699 (each), 40195327129690 (case),  Lot Numbers:  23EBA780, 23EBS770, 23GBT274.      22) DYNJ51038R:  UDI/DI 10195327298258 (each), 40195327298259 (case),  Lot Numbers:  23HBD834.      23) DYNJ56838F:  UDI/DI 10195327277857 (each), 40195327277858 (case),  Lot Numbers:  23GDA228, 23HDA839.      24) DYNJ56839D:  UDI/DI 10195327277864 (each), 40195327277865 (case),  Lot Numbers:  23GDA320.      25) DYNJ60548B:  UDI/DI 10195327361761 (each), 40195327361762 (case),  Lot Numbers:  23EBD777, 23IBS545, 23JBJ740.     26) DYNJ60783B:  UDI/DI 10195327361846 (each), 40195327361847 (case),  Lot Numbers :  23EBR616, 23GBW384, 23IBV398.    27) DYNJ61659A:  UDI/DI 10193489929638 (each), 40193489929639 (case),  Lot Numbers:  23HBI627.     28) DYNJ62097C:  UDI/DI 10195327189839 (each), 40195327189830 (case),  Lot Numbers:  23DBJ117, 23EBD473, 23HBQ663, 23IBB641.    29) DYNJ65039C:  UDI/DI 10195327528256 (each), 40195327528257 (case),  Lot Numbers:  24BMF955, 24CMB409, 24CME382, 24FMH176.      30) DYNJ66033B:  UDI/DI 10195327680589 (each), 40195327680580 (case),  Lot Numbers:  24EBA176.     31) DYNJ80609D:  UDI/DI 10195327298296 (each), 40195327298297 (case),  Lot Numbers:  23HBR318, 23HBZ183.      32) DYNJ81581B:  UDI/DI 10195327379254 (each), 40195327379255 (case),  Lot Numbers: 23EBO537, 23GBQ499, 23HBG425.        33) DYNJ81605:  UDI/DI 10195327123888 (each), 40195327123889 (case),  Lot Numbers:  23DBL829, 23EBI374, 23EBM656.     34) DYNJ81610B:  UDI/DI 10195327398316 (each), 40195327398317 (case),  Lot Numbers:   23EBA748, 23IBP506.     35) DYNJ82166:  UDI/DI 10195327182564 (each), 40195327182565 (case),  Lot Numbers:  23FDA955.      36) DYNJ82217:  UDI/DI 10195327183585 (each), 40195327183586 (case),  Lot Numbers:  23DDB931, 23HDA667.      37) DYNJ84017B:  UDI/DI 10198459253089 (each), 40198459253080 (case),  Lot Numbers:  25CMF132.      38) DYNJ85109:  UDI/DI 10195327460594 (each), 40195327460595 (case),  Lot Numbers:  23JBD986.    39) DYNJ85110:  UDI/DI 10195327460792 (each), 40195327460793 (case),  Lot Numbers: 23KBF140.     40) DYNJ85118:  UDI/DI 10195327460730 (each), 40195327460731 (case),  Lot Numbers: 23KBI277.     41) DYNJ85121:  UDI/DI 10195327460853 (each), 40195327460854 (case),  Lot Numbers:  23IBR236, 23JBC564.    42) DYNJ85637:  UDI/DI 10195327528188 (each), 40195327528189 (case),  Lot Numbers: 24CBL150.     43) DYNJ900293K:  UDI/DI 10195327554064 (each), 40195327554065 (case),  Lot Numbers:  24ABE610, 24BBT270, 24DBU219.     44) DYNJ900714C:  UDI/DI 10193489951363 (each), 40193489951364 (case),  Lot Numbers:  23FBL767, 23HBW562, 23JBF697.    45) DYNJ901066K:  UDI/DI 10195327239282 (each), 40195327239283 (case),  Lot Numbers:  23HBB464, 23HBC020, 23JBF553, 23JBW634.    46) DYNJ903042P:  UDI/DI 10195327438388 (each), 40195327438389 (case),  Lot Numbers:  23JBL424, 23LBL094, 24ABS138.    47) DYNJ905079F:  UDI/DI 10195327209001 (each), 40195327209002 (case),  Lot Numbers:  23GBV464, 23HBO354.    48) DYNJ905497B:  UDI/DI 10193489951639 (each), 40193489951630 (case),  Lot Numbers:  23GBB505, 23HBN192, 23JBV542, 23JBV684.    49) DYNJ906175B:  UDI/DI 10195327480127 (each), 40195327480128 (case),  Lot Numbers:  24FMI570.    50) DYNJ907105D:  UDI/DI 10195327233624 (each), 40195327233625 (case),  Lot Numbers:  23EBG144, 23EBT013, 23FBI805, 23FBQ992.    51) DYNJ907904A:  UDI/DI 10193489992434 (each), 40193489992435 (case),  Lot Numbers:  23JME513, 23KMD522.    52) DYNJ908820:  UDI/DI 10195327185671 (each), 40195327185672 (case),  Lot Numbers:  23JMG465, 23KMI460.     53) DYNJ908820A:  UDI/DI 10195327546045 (each), 40195327546046 (case),  Lot Numbers:  23LMH559, 24CMA145, 24DMF994, 24DMI666.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}