{
  "@context": {
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    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3024-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:    1) PREP TRAY, Pack Number DYNDA1540;   2) STERILE PREP TRAY , Pack Number DYNDA2499;   3) ED PREP TRAY, Pack Number DYNDA2519;   4) ED PREP TRAY, Pack Number DYNDA2519H ;   5) PRE-OP PREP KIT , Pack Number DYNDA3076;   6) PILGRIM PREP TRAY , Pack Number DYNDC3282;   7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ;   8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ;   9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ;   10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ;   11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ;   12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ;   13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ;   14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ;   15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ;   16) PK-SETUP PACK , Pack Number DYNJ43804A ;   17) SKIN LESION PACK, Pack Number DYNJ44258G ;   18) SETUP PACK, Pack Number DYNJ46187D ;   19) PK-SET UP -LF , Pack Number DYNJ53220B ;   20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ;   21) SKIN SCRUB PACK , Pack Number DYNJ68561;   22) DMEK PREP PACK, Pack Number DYNJ81659A ;   23) SET UP PACK , Pack Number DYNJ84247;   24) BASIC SET UP PACK-LF, Pack Number DYNJ85036;   25) SET UP CDS-ASC, Pack Number DYNJ900073C;   26) GENERAL SET UP, Pack Number DYNJ906282C;   27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A;   28) SET UP, Pack Number DYNJ909403 ;   29) PREP TRAY , Pack Number DYNJRA1280A;   30) PREP TRAY , Pack Number DYNJRA1424 ;   31) NERVE BLOCK/W , Pack Number DYNJRA1424H;   32) PREP TRAY, Pack Number DYNJRA1498B;   33) PREP TRAY , Pack Number DYNJRA1583C;   34) PREP TRAY , Pack Number DYNJRA1760 ;   35) PREP TRAY , Pack Number DYNJRA1774 ;   36) PREP TRAY , Pack Number DYNJRA1783 ;   37) PREP TRAY , Pack Number DYNJRA1946A;   38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ;   39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A",
  "description": "FDA recall Z-3024-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) PREP TRAY, Pack Number DYNDA1540;   2) STERILE PREP TRAY , Pack Number DYNDA2499;   3) ED PREP TRAY, Pack Number DYNDA2519;   4) ED PREP TRAY, Pack Number DYNDA2519H ;   5) PRE-OP PREP KIT , Pack Number DYNDA3076;   6) PILGRIM PREP TRAY , Pack Number DYNDC3282;   7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ;   8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ;   9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ;   10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ;   11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ;   12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ;   13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ;   14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ;   15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ;   16) PK-SETUP PACK , Pack Number DYNJ43804A ;   17) SKIN LESION PACK, Pack Number DYNJ44258G ;   18) SETUP PACK, Pack Number DYNJ46187D ;   19) PK-SET UP -LF , Pack Number DYNJ53220B ;   20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ;   21) SKIN SCRUB PACK , Pack Number DYNJ68561;   22) DMEK PREP PACK, Pack Number DYNJ81659A ;   23) SET UP PACK , Pack Number DYNJ84247;   24) BASIC SET UP PACK-LF, Pack Number DYNJ85036;   25) SET UP CDS-ASC, Pack Number DYNJ900073C;   26) GENERAL SET UP, Pack Number DYNJ906282C;   27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A;   28) SET UP, Pack Number DYNJ909403 ;   29) PREP TRAY , Pack Number DYNJRA1280A;   30) PREP TRAY , Pack Number DYNJRA1424 ;   31) NERVE BLOCK/W , Pack Number DYNJRA1424H;   32) PREP TRAY, Pack Number DYNJRA1498B;   33) PREP TRAY , Pack Number DYNJRA1583C;   34) PREP TRAY , Pack Number DYNJRA1760 ;   35) PREP TRAY , Pack Number DYNJRA1774 ;   36) PREP TRAY , Pack Number DYNJRA1783 ;   37) PREP TRAY , Pack Number DYNJRA1946A;   38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ;   39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A (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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3024-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:    1) PREP TRAY, Pack Number DYNDA1540;   2) STERILE PREP TRAY , Pack Number DYNDA2499;   3) ED PREP TRAY, Pack Number DYNDA2519;   4) ED PREP TRAY, Pack Number DYNDA2519H ;   5) PRE-OP PREP KIT , Pack Number DYNDA3076;   6) PILGRIM PREP TRAY , Pack Number DYNDC3282;   7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ;   8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ;   9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ;   10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ;   11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ;   12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ;   13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ;   14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ;   15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ;   16) PK-SETUP PACK , Pack Number DYNJ43804A ;   17) SKIN LESION PACK, Pack Number DYNJ44258G ;   18) SETUP PACK, Pack Number DYNJ46187D ;   19) PK-SET UP -LF , Pack Number DYNJ53220B ;   20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ;   21) SKIN SCRUB PACK , Pack Number DYNJ68561;   22) DMEK PREP PACK, Pack Number DYNJ81659A ;   23) SET UP PACK , Pack Number DYNJ84247;   24) BASIC SET UP PACK-LF, Pack Number DYNJ85036;   25) SET UP CDS-ASC, Pack Number DYNJ900073C;   26) GENERAL SET UP, Pack Number DYNJ906282C;   27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A;   28) SET UP, Pack Number DYNJ909403 ;   29) PREP TRAY , Pack Number DYNJRA1280A;   30) PREP TRAY , Pack Number DYNJRA1424 ;   31) NERVE BLOCK/W , Pack Number DYNJRA1424H;   32) PREP TRAY, Pack Number DYNJRA1498B;   33) PREP TRAY , Pack Number DYNJRA1583C;   34) PREP TRAY , Pack Number DYNJRA1760 ;   35) PREP TRAY , Pack Number DYNJRA1774 ;   36) PREP TRAY , Pack Number DYNJRA1783 ;   37) PREP TRAY , Pack Number DYNJRA1946A;   38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ;   39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3024-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3024-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) PREP TRAY, Pack Number DYNDA1540;   2) STERILE PREP TRAY , Pack Number DYNDA2499;   3) ED PREP TRAY, Pack Number DYNDA2519;   4) ED PREP TRAY, Pack Number DYNDA2519H ;   5) PRE-OP PREP KIT , Pack Number DYNDA3076;   6) PILGRIM PREP TRAY , Pack Number DYNDC3282;   7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ;   8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ;   9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ;   10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ;   11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ;   12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ;   13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ;   14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ;   15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ;   16) PK-SETUP PACK , Pack Number DYNJ43804A ;   17) SKIN LESION PACK, Pack Number DYNJ44258G ;   18) SETUP PACK, Pack Number DYNJ46187D ;   19) PK-SET UP -LF , Pack Number DYNJ53220B ;   20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ;   21) SKIN SCRUB PACK , Pack Number DYNJ68561;   22) DMEK PREP PACK, Pack Number DYNJ81659A ;   23) SET UP PACK , Pack Number DYNJ84247;   24) BASIC SET UP PACK-LF, Pack Number DYNJ85036;   25) SET UP CDS-ASC, Pack Number DYNJ900073C;   26) GENERAL SET UP, Pack Number DYNJ906282C;   27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A;   28) SET UP, Pack Number DYNJ909403 ;   29) PREP TRAY , Pack Number DYNJRA1280A;   30) PREP TRAY , Pack Number DYNJRA1424 ;   31) NERVE BLOCK/W , Pack Number DYNJRA1424H;   32) PREP TRAY, Pack Number DYNJRA1498B;   33) PREP TRAY , Pack Number DYNJRA1583C;   34) PREP TRAY , Pack Number DYNJRA1760 ;   35) PREP TRAY , Pack Number DYNJRA1774 ;   36) PREP TRAY , Pack Number DYNJRA1783 ;   37) PREP TRAY , Pack Number DYNJRA1946A;   38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ;   39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A",
      "text": "The FDA logged enforcement record Z-3024-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:    1) PREP TRAY, Pack Number DYNDA1540;   2) STERILE PREP TRAY , Pack Number DYNDA2499;   3) ED PREP TRAY, Pack Number DYNDA2519;   4) ED PREP TRAY, Pack Number DYNDA2519H ;   5) PRE-OP PREP KIT , Pack Number DYNDA3076;   6) PILGRIM PREP TRAY , Pack Number DYNDC3282;   7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ;   8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ;   9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ;   10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ;   11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ;   12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ;   13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ;   14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ;   15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ;   16) PK-SETUP PACK , Pack Number DYNJ43804A ;   17) SKIN LESION PACK, Pack Number DYNJ44258G ;   18) SETUP PACK, Pack Number DYNJ46187D ;   19) PK-SET UP -LF , Pack Number DYNJ53220B ;   20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ;   21) SKIN SCRUB PACK , Pack Number DYNJ68561;   22) DMEK PREP PACK, Pack Number DYNJ81659A ;   23) SET UP PACK , Pack Number DYNJ84247;   24) BASIC SET UP PACK-LF, Pack Number DYNJ85036;   25) SET UP CDS-ASC, Pack Number DYNJ900073C;   26) GENERAL SET UP, Pack Number DYNJ906282C;   27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A;   28) SET UP, Pack Number DYNJ909403 ;   29) PREP TRAY , Pack Number DYNJRA1280A;   30) PREP TRAY , Pack Number DYNJRA1424 ;   31) NERVE BLOCK/W , Pack Number DYNJRA1424H;   32) PREP TRAY, Pack Number DYNJRA1498B;   33) PREP TRAY , Pack Number DYNJRA1583C;   34) PREP TRAY , Pack Number DYNJRA1760 ;   35) PREP TRAY , Pack Number DYNJRA1774 ;   36) PREP TRAY , Pack Number DYNJRA1783 ;   37) PREP TRAY , Pack Number DYNJRA1946A;   38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ;   39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: DYNDA1540, Lot Number 23JBV995;  DYNDA1540, Lot Number 23GBA155;  DYNDA1540, Lot Number 23EBB508;  DYNDA1540, Lot Number 22LBK096;  DYNDA1540, Lot Number 22JBQ748;  DYNDA1540, Lot Number 22HBC421;  DYNDA1540, Lot Number 22DBP691;  DYNDA1540, Lot Number 22ABU584;  DYNDA1540, Lot Number 21BBI623;  DYNDA1540, Lot Number 20LBU589;  DYNDA1540, Lot Number 20KBL865;  DYNDA1540, Lot Number 20JBP526;  DYNDA1540, Lot Number 20IBD073;  DYNDA1540, Lot Number 20HBT535;  DYNDA1540, Lot Number 20HBQ630;  DYNDA1540, Lot Number 20HBB154;  DYNDA1540, Lot Number 2019050290;  DYNDA1540, Lot Number 2019061890;  DYNDA1540, Lot Number 2019071290;  DYNDA2499, Lot Number 21JBI254 ;  DYNDA2519, Lot Number 22FBC352 ;  DYNDA2519H , Lot Number 22FBC352 ;  DYNDA3076, Lot Number 24ABU746 ;  DYNDC3282, Lot Number 23CLA266 ;  DYNDC3282, Lot Number 23DLA289 ;  DYNDC3282, Lot Number 23FLA594 ;  DYNDC3282A , Lot Number 23HLA208 ;  DYNDC3282A , Lot Number 23ILA470 ;  DYNDC3282B , Lot Number 23LLA874 ;  DYNDC3282B , Lot Number 24CLA486 ;  DYNJ0618280G , Lot Number 19BBA500 ;  DYNJ0618280G , Lot Number 19BBK048 ;  DYNJ0618280I , Lot Number 21HBF705 ;  DYNJ0618280I , Lot Number 22EBJ300 ;  DYNJ0618280I , Lot Number 19PBC248 ;  DYNJ0618280I , Lot Number 19HBJ382 ;  DYNJ0618280I , Lot Number 20BBX426 ;  DYNJ0618280I , Lot Number 20DBN589 ;  DYNJ0618280I , Lot Number 20EBF905 ;  DYNJ0618280I , Lot Number 20IBA358 ;  DYNJ0618280I , Lot Number 20IBJ312 ;  DYNJ0618280I , Lot Number 20JBO345 ;  DYNJ0618280J , Lot Number 22LBE471 ;  DYNJ0618280J , Lot Number 23GBW260 ;  DYNJ0618280J , Lot Number 23KBE106 ;  DYNJ0738967A , Lot Number 19ABK292 ;  DYNJ0738967A , Lot Number 19ABS637 ;  DYNJ0738967A , Lot Number 19BBC096 ;  DYNJ0738967A , Lot Number 19FBG026 ;  DYNJ0738967A , Lot Number 19GBT425 ;  DYNJ0738967A , Lot Number 19IBM307 ;  DYNJ0738967A , Lot Number 19KBP191 ;  DYNJ0738967A , Lot Number 20ABR041 ;  DYNJ0738967A , Lot Number 20BBP817 ;  DYNJ0738967A , Lot Number 20CBU110 ;  DYNJ0738967A , Lot Number 20DBV286 ;  DYNJ0738967A , Lot Number 20EBF979 ;  DYNJ0738967A , Lot Number 20EBL088 ;  DYNJ0738967A , Lot Number 20FBH972 ;  DYNJ0738967A , Lot Number 20HBJ232 ;  DYNJ28988I , Lot Number 23FLA367 ;  DYNJ28988I , Lot Number 23GLA394 ;  DYNJ28988I , Lot Number 23GLB068 ;  DYNJ28988I , Lot Number 23HLA778 ;  DYNJ28988I , Lot Number 23JLA349 ;  DYNJ28988I , Lot Number 23JLB091 ;  DYNJ28988I , Lot Number 23LLA861 ;  DYNJ28988I , Lot Number 24BLA093 ;  DYNJ28988I , Lot Number 23LLA359 ;  DYNJ28988I , Lot Number 24CLA351 ;  DYNJ36311A , Lot Number 19BKC718 ;  DYNJ36311A , Lot Number 19CKC109 ;  DYNJ43804A , Lot Number 23ABS693 ;  DYNJ43804A , Lot Number 23DBJ631 ;  DYNJ43804A , Lot Number 23GBS752 ;  DYNJ43804A , Lot Number 23HBR871 ;  DYNJ43804A , Lot Number 23KBE834 ;  DYNJ43804A , Lot Number 23LBL776 ;  DYNJ44258G , Lot Number 21ADB154 ;  DYNJ46187D , Lot Number 23IMH258 ;  DYNJ46187D , Lot Number 23LMD118 ;  DYNJ53220B , Lot Number 22LMF612 ;  DYNJ53220B , Lot Number 23BMH755 ;  DYNJ53220B , Lot Number 23DMB617 ;  DYNJ53220B , Lot Number 23EME353 ;  DYNJ53220B , Lot Number 23FMC893 ;  DYNJ53220B , Lot Number 23FMJ703 ;  DYNJ53220B , Lot Number 23IMH249 ;  DYNJ53220B , Lot Number 23KMA406 ;  DYNJ53220B , Lot Number 24AMC542 ;  DYNJ64857A , Lot Number 23GMB325 ;  DYNJ68561, Lot Number 21GBT186 ;  DYNJ68561, Lot Number 21HBN324 ;  DYNJ68561, Lot Number 21IBF299 ;  DYNJ68561, Lot Number 21JBU945 ;  DYNJ68561, Lot Number 21KBR048 ;  DYNJ68561, Lot Number 22ABE326 ;  DYNJ68561, Lot Number 22CBZ837 ;  DYNJ68561, Lot Number 22EBR300 ;  DYNJ68561, Lot Number 22GBR532 ;  DYNJ68561, Lot Number 22IBA354 ;  DYNJ68561, Lot Number 22KBA954 ;  DYNJ68561, Lot Number 23BBD411 ;  DYNJ68561, Lot Number 23CBR350 ;  DYNJ68561, Lot Number 23DBJ393 ;  DYNJ68561, Lot Number 23EBJ138 ;  DYNJ68561, Lot Number 23FBI706 ;  DYNJ68561, Lot Number 23GBK621 ;  DYNJ68561, Lot Number 23IBL911 ;  DYNJ68561, Lot Number 23KBJ288 ;  DYNJ68561, Lot Number 23LBN184 ;  DYNJ68561, Lot Number 21CBA125 ;  DYNJ68561, Lot Number 21EBO241 ;  DYNJ81659A , Lot Number 22KBK040 ;  DYNJ84247, Lot Number 23DBF655 ;  DYNJ84247, Lot Number 23KBO915 ;  DYNJ85036, Lot Number 23IBO065 ;  DYNJ900073C, Lot Number 23GMG877 ;  DYNJ900073C, Lot Number 23IMB632 ;  DYNJ900073C, Lot Number 23JMH955 ;  DYNJ900073C, Lot Number 23KME142 ;  DYNJ906282C, Lot Number 23EMH718 ;  DYNJ906282C, Lot Number 23EMI365 ;  DYNJ906282C, Lot Number 23GMG364 ;  DYNJ906282C, Lot Number 23GMH729 ;  DYNJ906282C, Lot Number 23KMC248 ;  DYNJ906282C, Lot Number 23LME074 ;  DYNJ909261A, Lot Number 24ABA886 ;  DYNJ909403 , Lot Number 23BMH377 ;  DYNJ909403 , Lot Number 23CMC605 ;  DYNJ909403 , Lot Number 23CMG979 ;  DYNJ909403 , Lot Number 23EMD386 ;  DYNJ909403 , Lot Number 23HMC288 ;  DYNJ909403 , Lot Number 23HMI268 ;  DYNJ909403 , Lot Number 23JMJ496 ;  DYNJ909403 , Lot Number 23LMG588 ;  DYNJRA1280A, Lot Number 19DDB134 ;  DYNJRA1280A, Lot Number 19EDA093 ;  DYNJRA1280A, Lot Number 19FDA364 ;  DYNJRA1280A, Lot Number 19GDB114 ;  DYNJRA1424 , Lot Number 19SBF926 ;  DYNJRA1424 , Lot Number 22LBJ843 ;  DYNJRA1424 , Lot Number 19JBQ794 ;  DYNJRA1424 , Lot Number 19JBU300 ;  DYNJRA1424 , Lot Number 19KBU269 ;  DYNJRA1424 , Lot Number 19KBU874 ;  DYNJRA1424 , Lot Number 23DBO709 ;  DYNJRA1424 , Lot Number 23JBB394 ;  DYNJRA1424 , Lot Number 23JBO140 ;  DYNJRA1424H, Lot Number 19SBF926 ;  DYNJRA1424H, Lot Number 22LBJ843 ;  DYNJRA1424H, Lot Number 19JBQ794 ;  DYNJRA1424H, Lot Number 19JBU300 ;  DYNJRA1424H, Lot Number 19KBU269 ;  DYNJRA1424H, Lot Number 19KBU874 ;  DYNJRA1424H, Lot Number 23DBO709 ;  DYNJRA1424H, Lot Number 23JBB394 ;  DYNJRA1424H, Lot Number 23JBO140 ;  DYNJRA1498B, Lot Number 23LBH684;  DYNJRA1498B, Lot Number 23KBM001;  DYNJRA1498B, Lot Number 23HBR192;  DYNJRA1498B, Lot Number 23HBQ223;  DYNJRA1583C, Lot Number 22IBA106 ;  DYNJRA1583C, Lot Number 22IBM619 ;  DYNJRA1583C, Lot Number 22JBG212 ;  DYNJRA1583C, Lot Number 23ABG207 ;  DYNJRA1760 , Lot Number 21FBK824 ;  DYNJRA1760 , Lot Number 21GBQ183 ;  DYNJRA1760 , Lot Number 21HBG758 ;  DYNJRA1760 , Lot Number 21JBD045 ;  DYNJRA1760 , Lot Number 21KBF195 ;  DYNJRA1760 , Lot Number 21CBP879 ;  DYNJRA1774 , Lot Number 21EBN794 ;  DYNJRA1783 , Lot Number 21HBO497 ;  DYNJRA1783 , Lot Number 21JBT912 ;  DYNJRA1783 , Lot Number 22ABA947 ;  DYNJRA1783 , Lot Number 21DBU350 ;  DYNJRA1783 , Lot Number 22LMJ331 ;  DYNJRA1783 , Lot Number 23DMA884 ;  DYNJRA1946A, Lot Number 23IBN848 ;  PHS627837003 , Lot Number 21GBD048 ;  PHS627837003 , Lot Number 21IBK924 ;  PHS627837003 , Lot Number 21JBI944 ;  PHS627837003 , Lot Number 21JBZ984 ;  PHS627837003 , Lot Number 21KBQ074 ;  PHS627837003 , Lot Number 21LBI926 ;  PHS627837003 , Lot Number 20LBL907 ;  PHS627837003 , Lot Number 21ABL868 ;  PHS627837003 , Lot Number 21CBY701 ;  PHS627837003A, Lot Number 22EBS057 ;  PHS627837003A, Lot Number 22HBO070 ;  PHS627837003A, Lot Number 22IBF110 ;  PHS627837003A, Lot Number 22KBL329 ;  PHS627837003A, Lot Number 23DBN960 ;  PHS627837003A, Lot Number 23FBP926 ;  PHS627837003A, Lot Number 23HBT307 ;  PHS627837003A, Lot Number 23JBL440 ;  PHS627837003A, Lot Number 23JBY708 ;  PHS627837003A, Lot Number 23KBP182. 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-3024-2024&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-3024-2024&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-3024-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3024-2024 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-3024-2024&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-3024-2024&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-3024-2024/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."
    }
  ],
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          "item": {
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          "item": {
            "Field": "Reason",
            "Value": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
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            "Field": "Initiated",
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