{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0640-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "MEDLINE convenience kits labeled as:    1) BASIC NEURO PACK, REF CDS780202P;   2) BASIC NEURO PACK, REF CDS780202Q;   3) BASIC NEURO PACK, REF CDS780202R;   4) ACDF CDS, REF CDS941061M;   5) NEURO KIT, REF CDS981327Q;   6) ZALE V-P SHUNT CDS, REF CDS983186J;   7) NEURO PACK-LF, REF DYNJ0038440C;   8) NEURO PACK-LF, REF DYNJ0406347M;   9) NEURO-LF, REF DYNJ0484186M;   10) NEURO-LF, REF DYNJ0484186N;   11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K;   12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S;   13) NEURO-ORTHO EXTRAS, REF DYNJ44882L;   14) NEURO PACK, REF DYNJ57785B;   15) NEURO PACK, REF DYNJ60825B;   16) CHRISTUS MC NEURO PACK, REF DYNJ61157C;   17) CHRISTUS CHILDRENS NEURO PK, REF DYNJ61168C;   18) CHRISTUS CHILDRENS VP SHUNT PK, REF DYNJ61174C;   19) AFCH SHUNT, REF DYNJ63317C;   20) NEURO SPINE PK, REF DYNJ63319D;   21) NEURO CAROTID ENDARTERECTO, REF DYNJ63321D;   22) DBS PACK, REF DYNJ63322A;   23) NEURO LAM, REF DYNJ64188B;   24) PACK,V-P SHUNT, REF DYNJ65472B;   25) NEURO PK, REF DYNJ66735A;   26) DR. FONTES ADD-ON PK-LF, REF DYNJ66766B;   27) NEURO PACK, REF DYNJ68558A;   28) NEURO PACK, REF DYNJ69019C;   29) VP SHUNT, REF DYNJ81866A;   30) VP SHUNT, REF DYNJ81866B;   31) VP SHUNT, REF DYNJ81866C;   32) NEURO PACK, REF DYNJ84058A;   33) NEURO, REF DYNJ900420O;   34) CRANIO / NEURO / SPINE, REF DYNJ901072G;   35) CRANIO / NEURO / SPINE, REF DYNJ901072I;   36) LAMINECTOMY, REF DYNJ903870F;   37) MINOR NEURO, REF DYNJ904859C;   38) MINOR NEURO, REF DYNJ904859D;   39) MINOR NEURO, REF DYNJ904859F;   40) NEURO, REF DYNJ904861B;   41) NEURO, REF DYNJ904861D;   42) NEURO, REF DYNJ904861F;   43) NEURO, REF DYNJ904861G;   44) KIT V P SHUNT, REF DYNJ908835A;   45) GENERAL NEURO, REF DYNJ909744",
  "description": "FDA recall Z-0640-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE convenience kits labeled as:    1) BASIC NEURO PACK, REF CDS780202P;   2) BASIC NEURO PACK, REF CDS780202Q;   3) BASIC NEURO PACK, REF CDS780202R;   4) ACDF CDS, REF CDS941061M;   5) NEURO KIT, REF CDS981327Q;   6) ZALE V-P SHUNT CDS, REF CDS983186J;   7) NEURO PACK-LF, REF DYNJ0038440C;   8) NEURO PACK-LF, REF DYNJ0406347M;   9) NEURO-LF, REF DYNJ0484186M;   10) NEURO-LF, REF DYNJ0484186N;   11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K;   12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S;   13) NEURO-ORTHO EXTRAS, REF DYNJ44882L;   14) NEURO PACK, REF DYNJ57785B;   15) NEURO PACK, REF DYNJ60825B;   16) CHRISTUS MC NEURO PACK, REF DYNJ61157C;   17) CHRISTUS CHILDRENS NEURO PK, REF DYNJ61168C;   18) CHRISTUS CHILDRENS VP SHUNT PK, REF DYNJ61174C;   19) AFCH SHUNT, REF DYNJ63317C;   20) NEURO SPINE PK, REF DYNJ63319D;   21) NEURO CAROTID ENDARTERECTO, REF DYNJ63321D;   22) DBS PACK, REF DYNJ63322A;   23) NEURO LAM, REF DYNJ64188B;   24) PACK,V-P SHUNT, REF DYNJ65472B;   25) NEURO PK, REF DYNJ66735A;   26) DR. FONTES ADD-ON PK-LF, REF DYNJ66766B;   27) NEURO PACK, REF DYNJ68558A;   28) NEURO PACK, REF DYNJ69019C;   29) VP SHUNT, REF DYNJ81866A;   30) VP SHUNT, REF DYNJ81866B;   31) VP SHUNT, REF DYNJ81866C;   32) NEURO PACK, REF DYNJ84058A;   33) NEURO, REF DYNJ900420O;   34) CRANIO / NEURO / SPINE, REF DYNJ901072G;   35) CRANIO / NEURO / SPINE, REF DYNJ901072I;   36) LAMINECTOMY, REF DYNJ903870F;   37) MINOR NEURO, REF DYNJ904859C;   38) MINOR NEURO, REF DYNJ904859D;   39) MINOR NEURO, REF DYNJ904859F;   40) NEURO, REF DYNJ904861B;   41) NEURO, REF DYNJ904861D;   42) NEURO, REF DYNJ904861F;   43) NEURO, REF DYNJ904861G;   44) KIT V P SHUNT, REF DYNJ908835A;   45) GENERAL NEURO, REF DYNJ909744 (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-0640-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MEDLINE convenience kits labeled as:    1) BASIC NEURO PACK, REF CDS780202P;   2) BASIC NEURO PACK, REF CDS780202Q;   3) BASIC NEURO PACK, REF CDS780202R;   4) ACDF CDS, REF CDS941061M;   5) NEURO KIT, REF CDS981327Q;   6) ZALE V-P SHUNT CDS, REF CDS983186J;   7) NEURO PACK-LF, REF DYNJ0038440C;   8) NEURO PACK-LF, REF DYNJ0406347M;   9) NEURO-LF, REF DYNJ0484186M;   10) NEURO-LF, REF DYNJ0484186N;   11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K;   12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S;   13) NEURO-ORTHO EXTRAS, REF DYNJ44882L;   14) NEURO PACK, REF DYNJ57785B;   15) NEURO PACK, REF DYNJ60825B;   16) CHRISTUS MC NEURO PACK, REF DYNJ61157C;   17) CHRISTUS CHILDRENS NEURO PK, REF DYNJ61168C;   18) CHRISTUS CHILDRENS VP SHUNT PK, REF DYNJ61174C;   19) AFCH SHUNT, REF DYNJ63317C;   20) NEURO SPINE PK, REF DYNJ63319D;   21) NEURO CAROTID ENDARTERECTO, REF DYNJ63321D;   22) DBS PACK, REF DYNJ63322A;   23) NEURO LAM, REF DYNJ64188B;   24) PACK,V-P SHUNT, REF DYNJ65472B;   25) NEURO PK, REF DYNJ66735A;   26) DR. FONTES ADD-ON PK-LF, REF DYNJ66766B;   27) NEURO PACK, REF DYNJ68558A;   28) NEURO PACK, REF DYNJ69019C;   29) VP SHUNT, REF DYNJ81866A;   30) VP SHUNT, REF DYNJ81866B;   31) VP SHUNT, REF DYNJ81866C;   32) NEURO PACK, REF DYNJ84058A;   33) NEURO, REF DYNJ900420O;   34) CRANIO / NEURO / SPINE, REF DYNJ901072G;   35) CRANIO / NEURO / SPINE, REF DYNJ901072I;   36) LAMINECTOMY, REF DYNJ903870F;   37) MINOR NEURO, REF DYNJ904859C;   38) MINOR NEURO, REF DYNJ904859D;   39) MINOR NEURO, REF DYNJ904859F;   40) NEURO, REF DYNJ904861B;   41) NEURO, REF DYNJ904861D;   42) NEURO, REF DYNJ904861F;   43) NEURO, REF DYNJ904861G;   44) KIT V P SHUNT, REF DYNJ908835A;   45) GENERAL NEURO, REF DYNJ909744",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0640-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0640-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE convenience kits labeled as:    1) BASIC NEURO PACK, REF CDS780202P;   2) BASIC NEURO PACK, REF CDS780202Q;   3) BASIC NEURO PACK, REF CDS780202R;   4) ACDF CDS, REF CDS941061M;   5) NEURO KIT, REF CDS981327Q;   6) ZALE V-P SHUNT CDS, REF CDS983186J;   7) NEURO PACK-LF, REF DYNJ0038440C;   8) NEURO PACK-LF, REF DYNJ0406347M;   9) NEURO-LF, REF DYNJ0484186M;   10) NEURO-LF, REF DYNJ0484186N;   11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K;   12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S;   13) NEURO-ORTHO EXTRAS, REF DYNJ44882L;   14) NEURO PACK, REF DYNJ57785B;   15) NEURO PACK, REF DYNJ60825B;   16) CHRISTUS MC NEURO PACK, REF DYNJ61157C;   17) CHRISTUS CHILDRENS NEURO PK, REF DYNJ61168C;   18) CHRISTUS CHILDRENS VP SHUNT PK, REF DYNJ61174C;   19) AFCH SHUNT, REF DYNJ63317C;   20) NEURO SPINE PK, REF DYNJ63319D;   21) NEURO CAROTID ENDARTERECTO, REF DYNJ63321D;   22) DBS PACK, REF DYNJ63322A;   23) NEURO LAM, REF DYNJ64188B;   24) PACK,V-P SHUNT, REF DYNJ65472B;   25) NEURO PK, REF DYNJ66735A;   26) DR. FONTES ADD-ON PK-LF, REF DYNJ66766B;   27) NEURO PACK, REF DYNJ68558A;   28) NEURO PACK, REF DYNJ69019C;   29) VP SHUNT, REF DYNJ81866A;   30) VP SHUNT, REF DYNJ81866B;   31) VP SHUNT, REF DYNJ81866C;   32) NEURO PACK, REF DYNJ84058A;   33) NEURO, REF DYNJ900420O;   34) CRANIO / NEURO / SPINE, REF DYNJ901072G;   35) CRANIO / NEURO / SPINE, REF DYNJ901072I;   36) LAMINECTOMY, REF DYNJ903870F;   37) MINOR NEURO, REF DYNJ904859C;   38) MINOR NEURO, REF DYNJ904859D;   39) MINOR NEURO, REF DYNJ904859F;   40) NEURO, REF DYNJ904861B;   41) NEURO, REF DYNJ904861D;   42) NEURO, REF DYNJ904861F;   43) NEURO, REF DYNJ904861G;   44) KIT V P SHUNT, REF DYNJ908835A;   45) GENERAL NEURO, REF DYNJ909744",
      "text": "The FDA logged enforcement record Z-0640-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling MEDLINE convenience kits labeled as:    1) BASIC NEURO PACK, REF CDS780202P;   2) BASIC NEURO PACK, REF CDS780202Q;   3) BASIC NEURO PACK, REF CDS780202R;   4) ACDF CDS, REF CDS941061M;   5) NEURO KIT, REF CDS981327Q;   6) ZALE V-P SHUNT CDS, REF CDS983186J;   7) NEURO PACK-LF, REF DYNJ0038440C;   8) NEURO PACK-LF, REF DYNJ0406347M;   9) NEURO-LF, REF DYNJ0484186M;   10) NEURO-LF, REF DYNJ0484186N;   11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K;   12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S;   13) NEURO-ORTHO EXTRAS, REF DYNJ44882L;   14) NEURO PACK, REF DYNJ57785B;   15) NEURO PACK, REF DYNJ60825B;   16) CHRISTUS MC NEURO PACK, REF DYNJ61157C;   17) CHRISTUS CHILDRENS NEURO PK, REF DYNJ61168C;   18) CHRISTUS CHILDRENS VP SHUNT PK, REF DYNJ61174C;   19) AFCH SHUNT, REF DYNJ63317C;   20) NEURO SPINE PK, REF DYNJ63319D;   21) NEURO CAROTID ENDARTERECTO, REF DYNJ63321D;   22) DBS PACK, REF DYNJ63322A;   23) NEURO LAM, REF DYNJ64188B;   24) PACK,V-P SHUNT, REF DYNJ65472B;   25) NEURO PK, REF DYNJ66735A;   26) DR. FONTES ADD-ON PK-LF, REF DYNJ66766B;   27) NEURO PACK, REF DYNJ68558A;   28) NEURO PACK, REF DYNJ69019C;   29) VP SHUNT, REF DYNJ81866A;   30) VP SHUNT, REF DYNJ81866B;   31) VP SHUNT, REF DYNJ81866C;   32) NEURO PACK, REF DYNJ84058A;   33) NEURO, REF DYNJ900420O;   34) CRANIO / NEURO / SPINE, REF DYNJ901072G;   35) CRANIO / NEURO / SPINE, REF DYNJ901072I;   36) LAMINECTOMY, REF DYNJ903870F;   37) MINOR NEURO, REF DYNJ904859C;   38) MINOR NEURO, REF DYNJ904859D;   39) MINOR NEURO, REF DYNJ904859F;   40) NEURO, REF DYNJ904861B;   41) NEURO, REF DYNJ904861D;   42) NEURO, REF DYNJ904861F;   43) NEURO, REF DYNJ904861G;   44) KIT V P SHUNT, REF DYNJ908835A;   45) GENERAL NEURO, REF DYNJ909744 — reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-09. Affected lots/codes: 84OJG 1) REF CDS780202P, UDI/DI 10195327096458 (each) 40195327096459 (case), Lot Numbers:  22IMA512, 22IMA513, 22FMD852, 22GME200, 22FMH471, 22LMA065;  2) REF CDS780202Q, UDI/DI 10195327265304 (each) 40195327265305 (case), Lot Numbers:  22LMA225, 23EME852, 23DME052;  3) REF CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers:  23FMI343,  4) REF CDS941061M, UDI/DI 10193489445589 (each) 40193489445580 (case), Lot Numbers:  22EBB662, 22JBR840, 23ABG194, 23DBM361, 23BBR105;  5) REF CDS981327Q, UDI/DI 10195327080365 (each) 40195327080366 (case), Lot Numbers:  22GMH480, 22FMF883, 22FMH830, 23JMG480, 23CMF104, 23BMH848, 23BMG193, 23BMG197, 23KMF371, 23IMG472;  6) REF CDS983186J, UDI/DI 10195327105624 (each) 40195327105625 (case), Lot Numbers:  23CBO871, 22EBV250, 22EBU143, 23DBA498, 23DBO557;  7) REF DYNJ0038440C, UDI/DI 10195327356699 (each) 40195327356690 (case), Lot Numbers:  23GMC512, 23GMC697;  8) REF DYNJ0406347M, UDI/DI 10195327510701 (each) 40195327510702 (case), Lot Numbers:  23JMH534;  9) REF DYNJ0484186M, UDI/DI 10195327046057 (each) 40195327046058 (case), Lot Numbers:  22EBF993, 22GBB271, 22FBF013;  10) REF DYNJ0484186N, UDI/DI 10195327204150 (each) 40195327204151 (case), Lot Numbers:  22JBX539, 22IBD332, 23FBB054, 23DBI625, 23GBL780;  11) REF DYNJ0843121K, UDI/DI 10195327286491 (each) 40195327286492 (case), Lot Numbers:  23IDC125, 23EDB879, 23DDB255, 23GDA826;  12) REF DYNJ21925S, UDI/DI 10195327105020 (each) 40195327105021 (case), Lot Numbers:  22EBN168, 22EBB079, 22HBY426, 22EBB077, 22IBS173, 22JBV775, 22JBW872, 23ABK720, 23ABB556;  13) REF DYNJ44882L, UDI/DI 10195327127725 (each) 40195327127726 (case), Lot Numbers:  22FDA475, 22LDA151, 22KDA751, 22HDA703, 23BDC150, 23ADB774, 22IDB866;  14) REF DYNJ57785B, UDI/DI 10195327072643 (each) 40195327072644 (case), Lot Numbers:  22GMF726, 22FMD430, 23AMF372, 23HMD358, 23JME934;  15) REF DYNJ60825B, UDI/DI 10195327521301 (each) 40195327521302 (case), Lot Numbers:  23KBE951, 23JBH391;  16) REF DYNJ61157C, UDI/DI 10195327470234 (each) 40195327470235 (case), Lot Numbers:  23IBP298;  17) REF DYNJ61168C, UDI/DI 10195327470197 (each) 40195327470198 (case), Lot Numbers:  23IBQ047;  18) REF DYNJ61174C, UDI/DI 10195327470203 (each) 40195327470204 (case), Lot Numbers:  23ILA859, 23HLB095;  19) REF DYNJ63317C, UDI/DI 10195327273446 (each) 40195327273447 (case), Lot Numbers:  23AMG481, 23BMC514, 23JMG245;  20) REF DYNJ63319D, UDI/DI 10195327402167 (each) 40195327402168 (case), Lot Numbers:  23FMG396, 23KMI427;  21) REF DYNJ63321D, UDI/DI 10195327404154 (each) 40195327404155 (case), Lot Numbers:  23GMH332;  22) REF DYNJ63322A, UDI/DI 10193489958058 (each) 40193489958059 (case), Lot Numbers:  22FBX778;  23) REF DYNJ64188B, UDI/DI 10195327279721 (each) 40195327279722 (case), Lot Numbers:  22LBE618, 23BBD435, 23ABJ723, 22LBP476, 23FBR198, 23JBE272;  24) REF DYNJ65472B, UDI/DI 10195327303396 (each) 40195327303397 (case), Lot Numbers:  23AMI025, 22LMJ219, 23DMB323, 23JMJ552;  25) REF DYNJ66735A, UDI/DI 10195327504755 (each) 40195327504756 (case), Lot Numbers:  23KBC296, 23JBT150, 23KBL436, 24DBV652;  26) REF DYNJ66766B, UDI/DI 10195327286286 (each) 40195327286287 (case), Lot Numbers:  23HMH943;  27) REF DYNJ68558A, UDI/DI 10193489994926 (each) 40193489994927 (case), Lot Numbers:  22GBT930, 22JBN310, 22LBN425, 22LBE068, 23ABD982, 23FBG228, 23IBG968, 23GBE570;  28) REF DYNJ69019C, UDI/DI 10195327436674 (each) 40195327436675 (case), Lot Numbers:  23GBE293, 23JBL407, 23LBQ035;  29) REF DYNJ81866A, UDI/DI 10195327216467 (each) 40195327216468 (case), Lot Numbers:  22IMF886, 22LMF365;  30) REF DYNJ81866B, UDI/DI 10195327302252 (each) 40195327302253 (case), Lot Numbers:  23BMI434, 23BMC486;  31) REF DYNJ81866C, UDI/DI 10195327417109 (each) 40195327417100 (case), Lot Numbers:  23GMA996, 23HMF910, 23JMC277, 24BMA973, 24AMH042, 23KMF115, 23LMA617, 24EMC255, 24CMH446;  32) REF DYNJ84058A, UDI/DI 10195327358013 (each) 40195327358014 (case), Lot Numbers:  23DBB749;  33) REF DYNJ900420O, UDI/DI 10195327031688 (each) 40195327031689 (case), Lot Numbers:  22LBJ603, 23EBT299, 23EBN052, 23DBA431, 23DBD628, 23GBA726, 24BBK023, 23IBQ476, 23HBO727, 23JBW347, 23JBV912, 23LBI436, 24ABI190, 24DBD086;  34) REF DYNJ901072G, UDI/DI 10195327137540 (each) 40195327137541 (case), Lot Numbers:  22FMG228, 22FMG229, 22HME733;  35) REF DYNJ901072I, UDI/DI 10195327232580 (each) 40195327232581 (case), Lot Numbers:  23AMC161, 22LMB464, 22LMB450, 23CMC880, 23GMC001;  36) REF DYNJ903870F, UDI/DI 10195327239268 (each) 40195327239269 (case), Lot Numbers:  22KBF911;  37) REF DYNJ904859C, UDI/DI 10195327216603 (each) 40195327216604 (case), Lot Numbers:  22IMC571;  38) REF DYNJ904859D, UDI/DI 10195327247959 (each) 40195327247950 (case), Lot Numbers:  23BMI235, 23BMG396, 23BMD402, 23AMC121, 22JME888, 23CMF042;  39) REF DYNJ904859F, UDI/DI 10195327417116 (each) 40195327417117 (case), Lot Numbers:  23GMD960, 23HMI173, 23HMA500, 23FME591, 23IMG713, 23KMC264, 24EMC263, 24BMF111, 24AMD480, 23LMD169, 24CMH460;  40) REF DYNJ904861B, UDI/DI 10195327124786 (each) 40195327124787 (case), Lot Numbers:  22HMA130;  41) REF DYNJ904861D, UDI/DI 10195327247713 (each) 40195327247714 (case), Lot Numbers:  22LMD320, 22JMF457, 23CMB553, 23BMF721;  42) REF DYNJ904861F, UDI/DI 10195327416041 (each) 40195327416042 (case), Lot Numbers:  23JMI908, 23GMH228, 23FME592, 24CME226;  43) REF DYNJ904861G, UDI/DI 10198459004063 (each) 40198459004064 (case), Lot Numbers:  24FME276;  44) REF DYNJ908835A, UDI/DI 10195327546465 (each) 40195327546466 (case), Lot Numbers:  24AMA052, 24HMA162, 24GME380;  45) REF DYNJ909744, UDI/DI 10195327465636 (each) 40195327465637 (case), Lot Numbers:  23JLA320, 24ALA727. 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-0640-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0640-2025&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0640-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0640-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0640-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0640-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0640-2025/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-0640-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0640-2025",
            "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": "Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-10-09",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "84OJG 1) REF CDS780202P, UDI/DI 10195327096458 (each) 40195327096459 (case), Lot Numbers:  22IMA512, 22IMA513, 22FMD852, 22GME200, 22FMH471, 22LMA065;  2) REF CDS780202Q, UDI/DI 10195327265304 (each) 40195327265305 (case), Lot Numbers:  22LMA225, 23EME852, 23DME052;  3) REF CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers:  23FMI343,  4) REF CDS941061M, UDI/DI 10193489445589 (each) 40193489445580 (case), Lot Numbers:  22EBB662, 22JBR840, 23ABG194, 23DBM361, 23BBR105;  5) REF CDS981327Q, UDI/DI 10195327080365 (each) 40195327080366 (case), Lot Numbers:  22GMH480, 22FMF883, 22FMH830, 23JMG480, 23CMF104, 23BMH848, 23BMG193, 23BMG197, 23KMF371, 23IMG472;  6) REF CDS983186J, UDI/DI 10195327105624 (each) 40195327105625 (case), Lot Numbers:  23CBO871, 22EBV250, 22EBU143, 23DBA498, 23DBO557;  7) REF DYNJ0038440C, UDI/DI 10195327356699 (each) 40195327356690 (case), Lot Numbers:  23GMC512, 23GMC697;  8) REF DYNJ0406347M, UDI/DI 10195327510701 (each) 40195327510702 (case), Lot Numbers:  23JMH534;  9) REF DYNJ0484186M, UDI/DI 10195327046057 (each) 40195327046058 (case), Lot Numbers:  22EBF993, 22GBB271, 22FBF013;  10) REF DYNJ0484186N, UDI/DI 10195327204150 (each) 40195327204151 (case), Lot Numbers:  22JBX539, 22IBD332, 23FBB054, 23DBI625, 23GBL780;  11) REF DYNJ0843121K, UDI/DI 10195327286491 (each) 40195327286492 (case), Lot Numbers:  23IDC125, 23EDB879, 23DDB255, 23GDA826;  12) REF DYNJ21925S, UDI/DI 10195327105020 (each) 40195327105021 (case), Lot Numbers:  22EBN168, 22EBB079, 22HBY426, 22EBB077, 22IBS173, 22JBV775, 22JBW872, 23ABK720, 23ABB556;  13) REF DYNJ44882L, UDI/DI 10195327127725 (each) 40195327127726 (case), Lot Numbers:  22FDA475, 22LDA151, 22KDA751, 22HDA703, 23BDC150, 23ADB774, 22IDB866;  14) REF DYNJ57785B, UDI/DI 10195327072643 (each) 40195327072644 (case), Lot Numbers:  22GMF726, 22FMD430, 23AMF372, 23HMD358, 23JME934;  15) REF DYNJ60825B, UDI/DI 10195327521301 (each) 40195327521302 (case), Lot Numbers:  23KBE951, 23JBH391;  16) REF DYNJ61157C, UDI/DI 10195327470234 (each) 40195327470235 (case), Lot Numbers:  23IBP298;  17) REF DYNJ61168C, UDI/DI 10195327470197 (each) 40195327470198 (case), Lot Numbers:  23IBQ047;  18) REF DYNJ61174C, UDI/DI 10195327470203 (each) 40195327470204 (case), Lot Numbers:  23ILA859, 23HLB095;  19) REF DYNJ63317C, UDI/DI 10195327273446 (each) 40195327273447 (case), Lot Numbers:  23AMG481, 23BMC514, 23JMG245;  20) REF DYNJ63319D, UDI/DI 10195327402167 (each) 40195327402168 (case), Lot Numbers:  23FMG396, 23KMI427;  21) REF DYNJ63321D, UDI/DI 10195327404154 (each) 40195327404155 (case), Lot Numbers:  23GMH332;  22) REF DYNJ63322A, UDI/DI 10193489958058 (each) 40193489958059 (case), Lot Numbers:  22FBX778;  23) REF DYNJ64188B, UDI/DI 10195327279721 (each) 40195327279722 (case), Lot Numbers:  22LBE618, 23BBD435, 23ABJ723, 22LBP476, 23FBR198, 23JBE272;  24) REF DYNJ65472B, UDI/DI 10195327303396 (each) 40195327303397 (case), Lot Numbers:  23AMI025, 22LMJ219, 23DMB323, 23JMJ552;  25) REF DYNJ66735A, UDI/DI 10195327504755 (each) 40195327504756 (case), Lot Numbers:  23KBC296, 23JBT150, 23KBL436, 24DBV652;  26) REF DYNJ66766B, UDI/DI 10195327286286 (each) 40195327286287 (case), Lot Numbers:  23HMH943;  27) REF DYNJ68558A, UDI/DI 10193489994926 (each) 40193489994927 (case), Lot Numbers:  22GBT930, 22JBN310, 22LBN425, 22LBE068, 23ABD982, 23FBG228, 23IBG968, 23GBE570;  28) REF DYNJ69019C, UDI/DI 10195327436674 (each) 40195327436675 (case), Lot Numbers:  23GBE293, 23JBL407, 23LBQ035;  29) REF DYNJ81866A, UDI/DI 10195327216467 (each) 40195327216468 (case), Lot Numbers:  22IMF886, 22LMF365;  30) REF DYNJ81866B, UDI/DI 10195327302252 (each) 40195327302253 (case), Lot Numbers:  23BMI434, 23BMC486;  31) REF DYNJ81866C, UDI/DI 10195327417109 (each) 40195327417100 (case), Lot Numbers:  23GMA996, 23HMF910, 23JMC277, 24BMA973, 24AMH042, 23KMF115, 23LMA617, 24EMC255, 24CMH446;  32) REF DYNJ84058A, UDI/DI 10195327358013 (each) 40195327358014 (case), Lot Numbers:  23DBB749;  33) REF DYNJ900420O, UDI/DI 10195327031688 (each) 40195327031689 (case), Lot Numbers:  22LBJ603, 23EBT299, 23EBN052, 23DBA431, 23DBD628, 23GBA726, 24BBK023, 23IBQ476, 23HBO727, 23JBW347, 23JBV912, 23LBI436, 24ABI190, 24DBD086;  34) REF DYNJ901072G, UDI/DI 10195327137540 (each) 40195327137541 (case), Lot Numbers:  22FMG228, 22FMG229, 22HME733;  35) REF DYNJ901072I, UDI/DI 10195327232580 (each) 40195327232581 (case), Lot Numbers:  23AMC161, 22LMB464, 22LMB450, 23CMC880, 23GMC001;  36) REF DYNJ903870F, UDI/DI 10195327239268 (each) 40195327239269 (case), Lot Numbers:  22KBF911;  37) REF DYNJ904859C, UDI/DI 10195327216603 (each) 40195327216604 (case), Lot Numbers:  22IMC571;  38) REF DYNJ904859D, UDI/DI 10195327247959 (each) 40195327247950 (case), Lot Numbers:  23BMI235, 23BMG396, 23BMD402, 23AMC121, 22JME888, 23CMF042;  39) REF DYNJ904859F, UDI/DI 10195327417116 (each) 40195327417117 (case), Lot Numbers:  23GMD960, 23HMI173, 23HMA500, 23FME591, 23IMG713, 23KMC264, 24EMC263, 24BMF111, 24AMD480, 23LMD169, 24CMH460;  40) REF DYNJ904861B, UDI/DI 10195327124786 (each) 40195327124787 (case), Lot Numbers:  22HMA130;  41) REF DYNJ904861D, UDI/DI 10195327247713 (each) 40195327247714 (case), Lot Numbers:  22LMD320, 22JMF457, 23CMB553, 23BMF721;  42) REF DYNJ904861F, UDI/DI 10195327416041 (each) 40195327416042 (case), Lot Numbers:  23JMI908, 23GMH228, 23FME592, 24CME226;  43) REF DYNJ904861G, UDI/DI 10198459004063 (each) 40198459004064 (case), Lot Numbers:  24FME276;  44) REF DYNJ908835A, UDI/DI 10195327546465 (each) 40195327546466 (case), Lot Numbers:  24AMA052, 24HMA162, 24GME380;  45) REF DYNJ909744, UDI/DI 10195327465636 (each) 40195327465637 (case), Lot Numbers:  23JLA320, 24ALA727",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}