{
  "@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"
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    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
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    "operative": "au:operative",
    "grounding": "au:grounding",
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    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3001-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:    1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ;   2) ZALE OTOLOGY CDS, Pack Number CDS983181D ;   3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ;   4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ;   5) MEDIASTINOSCOPY PACK-LF , Pack Number DYNJ0796243F ;   6) RHINOPLASTY PACK, Pack Number DYNJ27333F ;   7) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384C ;   8) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384D ;   9) RHINO PACK, Pack Number DYNJ46504A ;   10) RHINO PACK, Pack Number DYNJ46504B ;   11) MEDIASTINOSCOPY TEGH-LF , Pack Number DYNJ46741B ;   12) PACEMAKER PACK, Pack Number DYNJ49787A ;   13) NASAL AND SINUS PACK, Pack Number DYNJ50425A ;   14) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677A ;   15) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677B ;   16) SEPTO RHINO PACK, Pack Number DYNJ53076C ;   17) PLASTIC ENT PACK - NTSC , Pack Number DYNJ54901A ;   18) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955B ;   19) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955C ;   20) MEDIASTINOSCOPY PACK, Pack Number DYNJ60872B ;   21) NOSE ESC, Pack Number DYNJ62371A ;   22) NASAL PACK, Pack Number DYNJ67789A ;   23) LOU MAJOR ENT , Pack Number DYNJ901851D;   24) LOU MINOR ENT , Pack Number DYNJ901852C;   25) RHYZOTOMY , Pack Number DYNJ902288G;   26) CHS NASAL AND SINUS PACK, Pack Number DYNJCH501",
  "description": "FDA recall Z-3001-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ;   2) ZALE OTOLOGY CDS, Pack Number CDS983181D ;   3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ;   4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ;   5) MEDIASTINOSCOPY PACK-LF , Pack Number DYNJ0796243F ;   6) RHINOPLASTY PACK, Pack Number DYNJ27333F ;   7) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384C ;   8) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384D ;   9) RHINO PACK, Pack Number DYNJ46504A ;   10) RHINO PACK, Pack Number DYNJ46504B ;   11) MEDIASTINOSCOPY TEGH-LF , Pack Number DYNJ46741B ;   12) PACEMAKER PACK, Pack Number DYNJ49787A ;   13) NASAL AND SINUS PACK, Pack Number DYNJ50425A ;   14) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677A ;   15) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677B ;   16) SEPTO RHINO PACK, Pack Number DYNJ53076C ;   17) PLASTIC ENT PACK - NTSC , Pack Number DYNJ54901A ;   18) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955B ;   19) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955C ;   20) MEDIASTINOSCOPY PACK, Pack Number DYNJ60872B ;   21) NOSE ESC, Pack Number DYNJ62371A ;   22) NASAL PACK, Pack Number DYNJ67789A ;   23) LOU MAJOR ENT , Pack Number DYNJ901851D;   24) LOU MINOR ENT , Pack Number DYNJ901852C;   25) RHYZOTOMY , Pack Number DYNJ902288G;   26) CHS NASAL AND SINUS PACK, Pack Number DYNJCH501 (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-3001-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:    1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ;   2) ZALE OTOLOGY CDS, Pack Number CDS983181D ;   3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ;   4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ;   5) MEDIASTINOSCOPY PACK-LF , Pack Number DYNJ0796243F ;   6) RHINOPLASTY PACK, Pack Number DYNJ27333F ;   7) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384C ;   8) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384D ;   9) RHINO PACK, Pack Number DYNJ46504A ;   10) RHINO PACK, Pack Number DYNJ46504B ;   11) MEDIASTINOSCOPY TEGH-LF , Pack Number DYNJ46741B ;   12) PACEMAKER PACK, Pack Number DYNJ49787A ;   13) NASAL AND SINUS PACK, Pack Number DYNJ50425A ;   14) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677A ;   15) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677B ;   16) SEPTO RHINO PACK, Pack Number DYNJ53076C ;   17) PLASTIC ENT PACK - NTSC , Pack Number DYNJ54901A ;   18) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955B ;   19) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955C ;   20) MEDIASTINOSCOPY PACK, Pack Number DYNJ60872B ;   21) NOSE ESC, Pack Number DYNJ62371A ;   22) NASAL PACK, Pack Number DYNJ67789A ;   23) LOU MAJOR ENT , Pack Number DYNJ901851D;   24) LOU MINOR ENT , Pack Number DYNJ901852C;   25) RHYZOTOMY , Pack Number DYNJ902288G;   26) CHS NASAL AND SINUS PACK, Pack Number DYNJCH501",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3001-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3001-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ;   2) ZALE OTOLOGY CDS, Pack Number CDS983181D ;   3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ;   4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ;   5) MEDIASTINOSCOPY PACK-LF , Pack Number DYNJ0796243F ;   6) RHINOPLASTY PACK, Pack Number DYNJ27333F ;   7) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384C ;   8) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384D ;   9) RHINO PACK, Pack Number DYNJ46504A ;   10) RHINO PACK, Pack Number DYNJ46504B ;   11) MEDIASTINOSCOPY TEGH-LF , Pack Number DYNJ46741B ;   12) PACEMAKER PACK, Pack Number DYNJ49787A ;   13) NASAL AND SINUS PACK, Pack Number DYNJ50425A ;   14) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677A ;   15) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677B ;   16) SEPTO RHINO PACK, Pack Number DYNJ53076C ;   17) PLASTIC ENT PACK - NTSC , Pack Number DYNJ54901A ;   18) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955B ;   19) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955C ;   20) MEDIASTINOSCOPY PACK, Pack Number DYNJ60872B ;   21) NOSE ESC, Pack Number DYNJ62371A ;   22) NASAL PACK, Pack Number DYNJ67789A ;   23) LOU MAJOR ENT , Pack Number DYNJ901851D;   24) LOU MINOR ENT , Pack Number DYNJ901852C;   25) RHYZOTOMY , Pack Number DYNJ902288G;   26) CHS NASAL AND SINUS PACK, Pack Number DYNJCH501",
      "text": "The FDA logged enforcement record Z-3001-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:    1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ;   2) ZALE OTOLOGY CDS, Pack Number CDS983181D ;   3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ;   4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ;   5) MEDIASTINOSCOPY PACK-LF , Pack Number DYNJ0796243F ;   6) RHINOPLASTY PACK, Pack Number DYNJ27333F ;   7) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384C ;   8) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384D ;   9) RHINO PACK, Pack Number DYNJ46504A ;   10) RHINO PACK, Pack Number DYNJ46504B ;   11) MEDIASTINOSCOPY TEGH-LF , Pack Number DYNJ46741B ;   12) PACEMAKER PACK, Pack Number DYNJ49787A ;   13) NASAL AND SINUS PACK, Pack Number DYNJ50425A ;   14) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677A ;   15) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677B ;   16) SEPTO RHINO PACK, Pack Number DYNJ53076C ;   17) PLASTIC ENT PACK - NTSC , Pack Number DYNJ54901A ;   18) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955B ;   19) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955C ;   20) MEDIASTINOSCOPY PACK, Pack Number DYNJ60872B ;   21) NOSE ESC, Pack Number DYNJ62371A ;   22) NASAL PACK, Pack Number DYNJ67789A ;   23) LOU MAJOR ENT , Pack Number DYNJ901851D;   24) LOU MINOR ENT , Pack Number DYNJ901852C;   25) RHYZOTOMY , Pack Number DYNJ902288G;   26) CHS NASAL AND SINUS PACK, Pack Number DYNJCH501 — 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: CDS983173G , Lot Number 21FBQ527 ;  CDS983173G , Lot Number 21HBF657 ;  CDS983173G , Lot Number 21IBE910 ;  CDS983173G , Lot Number 21IBM809 ;  CDS983173G , Lot Number 21JBJ185 ;  CDS983173G , Lot Number 21KBM498 ;  CDS983173G , Lot Number 22ABF773 ;  CDS983173G , Lot Number 22BBH011 ;  CDS983173G , Lot Number 19ABX210 ;  CDS983173G , Lot Number 22OBM500 ;  CDS983173G , Lot Number 22EBQ566 ;  CDS983173G , Lot Number 19GBS147 ;  CDS983173G , Lot Number 19IBG146 ;  CDS983173G , Lot Number 19IBJ785 ;  CDS983173G , Lot Number 19KBA219 ;  CDS983173G , Lot Number 19KBA926 ;  CDS983173G , Lot Number 20BBA113 ;  CDS983173G , Lot Number 20CBP609 ;  CDS983173G , Lot Number 20DBU576 ;  CDS983173G , Lot Number 20HBQ718 ;  CDS983173G , Lot Number 20KBY137 ;  CDS983173G , Lot Number 20LBL243 ;  CDS983173G , Lot Number 21BBO662 ;  CDS983173G , Lot Number 21EBC912 ;  CDS983181D , Lot Number 21FBP606 ;  CDS983181D , Lot Number 21FBP608 ;  CDS983181D , Lot Number 21GBM695 ;  CDS983181D , Lot Number 21IBW768 ;  CDS983181D , Lot Number 21KBT227 ;  CDS983181D , Lot Number 21KBT228 ;  CDS983181D , Lot Number 22ABD357 ;  CDS983181D , Lot Number 19ABU206 ;  CDS983181D , Lot Number 19BBQ372 ;  CDS983181D , Lot Number 19CBK097 ;  CDS983181D , Lot Number 22OBL824 ;  CDS983181D , Lot Number 19QBA591 ;  CDS983181D , Lot Number 19FBV743 ;  CDS983181D , Lot Number 19IBF802 ;  CDS983181D , Lot Number 19KBD950 ;  CDS983181D , Lot Number 19LBK648 ;  CDS983181D , Lot Number 20ABR683 ;  CDS983181D , Lot Number 20BBA165 ;  CDS983181D , Lot Number 20FBI684 ;  CDS983181D , Lot Number 20FBR746 ;  CDS983181D , Lot Number 20GBU594 ;  CDS983181D , Lot Number 20IBE821 ;  CDS983181D , Lot Number 20KBH269 ;  CDS983181D , Lot Number 20WBC647 ;  CDS983181D , Lot Number 20LBM653 ;  CDS983181D , Lot Number 21CBT353 ;  DYNJ0664747A , Lot Number 18LKD127 ;  DYNJ0664747A , Lot Number 19BKB344 ;  DYNJ0664747A , Lot Number 19CKC913 ;  DYNJ0664747A , Lot Number 19EKC333 ;  DYNJ0664747A , Lot Number 19FKC411 ;  DYNJ0664747A , Lot Number 19GKC274 ;  DYNJ0664747A , Lot Number 19HKB760 ;  DYNJ0664747A , Lot Number 19JKA880 ;  DYNJ0664747A , Lot Number 19LKB543 ;  DYNJ0664747A , Lot Number 20CKB577 ;  DYNJ0664747A , Lot Number 20FKB280 ;  DYNJ0796243D , Lot Number 19DBI829 ;  DYNJ0796243D , Lot Number 19FBR591 ;  DYNJ0796243D , Lot Number 19SBB284 ;  DYNJ0796243D , Lot Number 20ABR331 ;  DYNJ0796243D , Lot Number 20CBD369 ;  DYNJ0796243F , Lot Number 20DBS625 ;  DYNJ0796243F , Lot Number 20EBL722 ;  DYNJ0796243F , Lot Number 20IBA666 ;  DYNJ27333F , Lot Number 19BBO791 ;  DYNJ27333F , Lot Number 19DBP940 ;  DYNJ27333F , Lot Number 19FBE534 ;  DYNJ27333F , Lot Number 19GBR210 ;  DYNJ27333F , Lot Number 19IBE745 ;  DYNJ27333F , Lot Number 19JBS092 ;  DYNJ27333F , Lot Number 19LBW235 ;  DYNJ27333F , Lot Number 20ABI785 ;  DYNJ27333F , Lot Number 23IBA132 ;  DYNJ27333F , Lot Number 23IBM081 ;  DYNJ27333F , Lot Number 20GMB327 ;  DYNJ27333F , Lot Number 20HMC020 ;  DYNJ27333F , Lot Number 20JMB190 ;  DYNJ27333F , Lot Number 21BMA104 ;  DYNJ27333F , Lot Number 21CMC745 ;  DYNJ27333F , Lot Number 21EMA918 ;  DYNJ27333F , Lot Number 21EMF099 ;  DYNJ27333F , Lot Number 21GME154 ;  DYNJ27333F , Lot Number 21IMD341 ;  DYNJ27333F , Lot Number 21JMG293 ;  DYNJ27333F , Lot Number 21KMH297 ;  DYNJ27333F , Lot Number 22AMB529 ;  DYNJ27333F , Lot Number 22AME230 ;  DYNJ27333F , Lot Number 22CMA564 ;  DYNJ27333F , Lot Number 22EMC594 ;  DYNJ27333F , Lot Number 22JMD960 ;  DYNJ27333F , Lot Number 22LMA318 ;  DYNJ27333F , Lot Number 23BMI006 ;  DYNJ27333F , Lot Number 23DMF413 ;  DYNJ27333F , Lot Number 23EMI496 ;  DYNJ27333F , Lot Number 23FMF200 ;  DYNJ37384C , Lot Number 19ABU440 ;  DYNJ37384C , Lot Number 19CBU785 ;  DYNJ37384C , Lot Number 19FBL799 ;  DYNJ37384C , Lot Number 19GBW911 ;  DYNJ37384C , Lot Number 19IBA811 ;  DYNJ37384C , Lot Number 19JBH727 ;  DYNJ37384C , Lot Number 19KBT009 ;  DYNJ37384C , Lot Number 19LBS039 ;  DYNJ37384D , Lot Number 21GBK114 ;  DYNJ37384D , Lot Number 21IBR322 ;  DYNJ37384D , Lot Number 21KBG185 ;  DYNJ37384D , Lot Number 21LBO506 ;  DYNJ37384D , Lot Number 22FBJ098 ;  DYNJ37384D , Lot Number 22HBY172 ;  DYNJ37384D , Lot Number 22KBR101 ;  DYNJ37384D , Lot Number 23EBC350 ;  DYNJ37384D , Lot Number 20CBZ636 ;  DYNJ37384D , Lot Number 20EBS338 ;  DYNJ37384D , Lot Number 20FBK766 ;  DYNJ37384D , Lot Number 23JBO321 ;  DYNJ37384D , Lot Number 20HBB525 ;  DYNJ37384D , Lot Number 23LBL338 ;  DYNJ37384D , Lot Number 20IBJ892 ;  DYNJ37384D , Lot Number 21ABE659 ;  DYNJ37384D , Lot Number 21CBJ121 ;  DYNJ46504A , Lot Number 19BDB160 ;  DYNJ46504A , Lot Number 19DDB252 ;  DYNJ46504A , Lot Number 19EDC611 ;  DYNJ46504B , Lot Number 19JDA999 ;  DYNJ46504B , Lot Number 20BMB648 ;  DYNJ46504B , Lot Number 20DMB154 ;  DYNJ46504B , Lot Number 20HMB453 ;  DYNJ46504B , Lot Number 20KMB679 ;  DYNJ46504B , Lot Number 21BMB155 ;  DYNJ46504B , Lot Number 21CMB708 ;  DYNJ46504B , Lot Number 21EMB698 ;  DYNJ46504B , Lot Number 21GMD919 ;  DYNJ46504B , Lot Number 21IME243 ;  DYNJ46741B , Lot Number 21IBG995 ;  DYNJ46741B , Lot Number 21IBG997 ;  DYNJ46741B , Lot Number 22BBT724 ;  DYNJ46741B , Lot Number 19CBB765 ;  DYNJ46741B , Lot Number 22EBP222 ;  DYNJ46741B , Lot Number 19FBK777 ;  DYNJ46741B , Lot Number 19VBA126 ;  DYNJ46741B , Lot Number 19KBL310 ;  DYNJ46741B , Lot Number 19KBN384 ;  DYNJ46741B , Lot Number 23HBN994 ;  DYNJ46741B , Lot Number 23HBP810 ;  DYNJ49787A , Lot Number 21FBN016 ;  DYNJ49787A , Lot Number 21GBM408 ;  DYNJ49787A , Lot Number 21GBM428 ;  DYNJ49787A , Lot Number 22ABM108 ;  DYNJ49787A , Lot Number 19ABN326 ;  DYNJ49787A , Lot Number 19CBP767 ;  DYNJ49787A , Lot Number 19CBQ107 ;  DYNJ49787A , Lot Number 22DBM828 ;  DYNJ49787A , Lot Number 22EBG252 ;  DYNJ49787A , Lot Number 22IBJ471 ;  DYNJ49787A , Lot Number 19HBY419 ;  DYNJ49787A , Lot Number 19IBT824 ;  DYNJ49787A , Lot Number 19JBW889 ;  DYNJ49787A , Lot Number 19KBE624 ;  DYNJ49787A , Lot Number 23BBA335 ;  DYNJ49787A , Lot Number 23BBA675 ;  DYNJ49787A , Lot Number 19LBW938 ;  DYNJ49787A , Lot Number 23EBH476 ;  DYNJ49787A , Lot Number 20DBR037 ;  DYNJ49787A , Lot Number 23HBP202 ;  DYNJ49787A , Lot Number 23IBS466 ;  DYNJ49787A , Lot Number 20FBC511 ;  DYNJ49787A , Lot Number 20GBS300 ;  DYNJ49787A , Lot Number 20HBM368 ;  DYNJ49787A , Lot Number 20HBS801 ;  DYNJ49787A , Lot Number 20IBN275 ;  DYNJ49787A , Lot Number 21BBF686 ;  DYNJ49787A , Lot Number 21OBA269 ;  DYNJ50425A , Lot Number 21HBA360 ;  DYNJ50425A , Lot Number 21IBQ864 ;  DYNJ50425A , Lot Number 19BBQ595 ;  DYNJ50425A , Lot Number 19EBY242 ;  DYNJ50425A , Lot Number 19FBI087 ;  DYNJ50425A , Lot Number 20BBE774 ;  DYNJ50425A , Lot Number 20EBK250 ;  DYNJ50425A , Lot Number 20JBC222 ;  DYNJ50425A , Lot Number 20WBD637 ;  DYNJ50425A , Lot Number 21ABT114 ;  DYNJ51677A , Lot Number 19BDA361 ;  DYNJ51677A , Lot Number 19DDC824 ;  DYNJ51677A , Lot Number 19GDB503 ;  DYNJ51677A , Lot Number 19HDB601 ;  DYNJ51677B , Lot Number 19LDB205 ;  DYNJ51677B , Lot Number 20ADA661 ;  DYNJ51677B , Lot Number 20BDC766 ;  DYNJ51677B , Lot Number 20FDA983 ;  DYNJ51677B , Lot Number 21DDB294 ;  DYNJ51677B , Lot Number 21DDB913 ;  DYNJ51677B , Lot Number 21IDA884 ;  DYNJ51677B , Lot Number 21KDB891 ;  DYNJ51677B , Lot Number 22BDB470 ;  DYNJ51677B , Lot Number 22FDA247 ;  DYNJ53076C , Lot Number 19ABB038 ;  DYNJ53076C , Lot Number 19DBB639 ;  DYNJ53076C , Lot Number 19IBM131 ;  DYNJ54901A , Lot Number 20FMB225 ;  DYNJ54901A , Lot Number 20GMB646 ;  DYNJ54901A , Lot Number 19CKB852 ;  DYNJ54901A , Lot Number 19CKD589 ;  DYNJ54901A , Lot Number 19GKA497 ;  DYNJ54901A , Lot Number 19HKA603 ;  DYNJ54901A , Lot Number 19IKA618 ;  DYNJ54901A , Lot Number 19JKA239 ;  DYNJ54901A , Lot Number 19KKA565 ;  DYNJ54901A , Lot Number 20AKB491 ;  DYNJ55955B , Lot Number 20GBI567 ;  DYNJ55955C , Lot Number 20IBM103 ;  DYNJ55955C , Lot Number 20JBO651 ;  DYNJ55955C , Lot Number 20KBZ444 ;  DYNJ55955C , Lot Number 21ABF008 ;  DYNJ55955C , Lot Number 21OBA488 ;  DYNJ55955C , Lot Number 21DBP964 ;  DYNJ55955C , Lot Number 21EBN493 ;  DYNJ55955C , Lot Number 21FBB400 ;  DYNJ60872B , Lot Number 21HBG657 ;  DYNJ60872B , Lot Number 22GBF268 ;  DYNJ60872B , Lot Number 23JBX988 ;  DYNJ60872B , Lot Number 21FBG560 ;  DYNJ62371A , Lot Number 19HBX688 ;  DYNJ62371A , Lot Number 19JBX716 ;  DYNJ62371A , Lot Number 19KBZ297 ;  DYNJ62371A , Lot Number 19LBW815 ;  DYNJ62371A , Lot Number 20CBL259 ;  DYNJ62371A , Lot Number 20CBT802 ;  DYNJ62371A , Lot Number 20GBA607 ;  DYNJ67789A , Lot Number 21GBW066 ;  DYNJ67789A , Lot Number 21JBK474 ;  DYNJ67789A , Lot Number 21KBS434 ;  DYNJ67789A , Lot Number 21KBX401 ;  DYNJ67789A , Lot Number 22OBB247 ;  DYNJ67789A , Lot Number 22FBW392 ;  DYNJ67789A , Lot Number 23BBB609 ;  DYNJ67789A , Lot Number 23EBD035 ;  DYNJ67789A , Lot Number 23FBJ867 ;  DYNJ67789A , Lot Number 23GBS485 ;  DYNJ67789A , Lot Number 23KBP837 ;  DYNJ901851D, Lot Number 21HBJ140 ;  DYNJ901851D, Lot Number 22BBU915 ;  DYNJ901851D, Lot Number 22CBC697 ;  DYNJ901851D, Lot Number 22DBK808 ;  DYNJ901851D, Lot Number 22FBB271 ;  DYNJ901851D, Lot Number 22GBT167 ;  DYNJ901851D, Lot Number 22HBI855 ;  DYNJ901851D, Lot Number 22HBS216 ;  DYNJ901851D, Lot Number 22IBK656 ;  DYNJ901851D, Lot Number 20XBC489 ;  DYNJ901851D, Lot Number 21BBN648 ;  DYNJ901851D, Lot Number 21DBL095 ;  DYNJ901852C, Lot Number 21HBF301 ;  DYNJ901852C, Lot Number 21JBJ762 ;  DYNJ901852C, Lot Number 22NBF331 ;  DYNJ901852C, Lot Number 22HBA397 ;  DYNJ901852C, Lot Number 22HBS590 ;  DYNJ901852C, Lot Number 22IBJ339 ;  DYNJ901852C, Lot Number 22IBK137 ;  DYNJ901852C, Lot Number 22JBQ953 ;  DYNJ901852C, Lot Number 23CBO466 ;  DYNJ901852C, Lot Number 20JBP459 ;  DYNJ901852C, Lot Number 20KBU993 ;  DYNJ901852C, Lot Number 20LBI528 ;  DYNJ902288G, Lot Number 21HBF299 ;  DYNJ902288G, Lot Number 21KBE091 ;  DYNJ902288G, Lot Number 22BBV084 ;  DYNJ902288G, Lot Number 22CBU916 ;  DYNJ902288G, Lot Number 22GBF564 ;  DYNJ902288G, Lot Number 22HBR861 ;  DYNJ902288G, Lot Number 22JBT657 ;  DYNJ902288G, Lot Number 22JBU356 ;  DYNJ902288G, Lot Number 22LBE926 ;  DYNJ902288G, Lot Number 23ABP445 ;  DYNJ902288G, Lot Number 23EBV643 ; 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A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-3001-2024&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-3001-2024&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-3001-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3001-2024 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",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-3001-2024&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-3001-2024&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-3001-2024/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",
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        "adjudged": false,
        "operative": true
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "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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