{
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    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
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    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
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    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
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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-3045-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:    1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ;   2) GROTH PELVISCOPY, Pack Number CDS984187U ;   3) DERMATOLOGY KIT, Pack Number DYNDA1567D;   4) ER MINOR SUTURE SET, Pack Number DYNDA1977A;   5) HSG TRAY, Pack Number DYNDH1453;   6) TRAY, ER LACERATION, Pack Number DYNDL1569A;   7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ;   8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ;   9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ;   10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ;   11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ;   12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ;   13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ;   14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ;   15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ;   16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ;   17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ;   18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ;   19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ;   20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ;   21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ;   22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ;   23) PELVISCOPY PACK , Pack Number DYNJ50688D ;   24) PELVISCOPY PACK , Pack Number DYNJ50688F ;   25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ;   26) PELVIC LAP, Pack Number DYNJ53601G ;   27) VAGINAL PACK, Pack Number DYNJ59786B ;   28) PELVIC PACK , Pack Number DYNJ63057D ;   29) PELVIC PACK , Pack Number DYNJ63057F ;   30) PERI GYN, Pack Number DYNJ64239B ;   31) OB GYN PACK , Pack Number DYNJ80831;   32) MON OB GYN PACK , Pack Number DYNJ80831A ;   33) MON OB GYN PACK , Pack Number DYNJ80831B ;   34) LAP PELVISCOPY PACK , Pack Number DYNJ82449;   35) PELVISCOPY PACK , Pack Number DYNJ82555;   36) PELVISCOPY PACK , Pack Number DYNJ82555A ;   37) PELVISCOPY, Pack Number DYNJ82676;   38) PERIPELVIC PACK , Pack Number DYNJ83912;   39) PELVISCOPY PACK , Pack Number DYNJ84379;   40) PELVISCOPY PACK , Pack Number DYNJ85311;   41) D-PELVISCOPY, Pack Number DYNJ900628I;   42) PELVISCOPY, Pack Number DYNJ901655F;   43) PELVISCOPY, Pack Number DYNJ901655G;   44) PELVISCOPY, Pack Number DYNJ908446B;   45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A;   46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B",
  "description": "FDA recall Z-3045-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ;   2) GROTH PELVISCOPY, Pack Number CDS984187U ;   3) DERMATOLOGY KIT, Pack Number DYNDA1567D;   4) ER MINOR SUTURE SET, Pack Number DYNDA1977A;   5) HSG TRAY, Pack Number DYNDH1453;   6) TRAY, ER LACERATION, Pack Number DYNDL1569A;   7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ;   8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ;   9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ;   10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ;   11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ;   12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ;   13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ;   14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ;   15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ;   16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ;   17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ;   18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ;   19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ;   20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ;   21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ;   22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ;   23) PELVISCOPY PACK , Pack Number DYNJ50688D ;   24) PELVISCOPY PACK , Pack Number DYNJ50688F ;   25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ;   26) PELVIC LAP, Pack Number DYNJ53601G ;   27) VAGINAL PACK, Pack Number DYNJ59786B ;   28) PELVIC PACK , Pack Number DYNJ63057D ;   29) PELVIC PACK , Pack Number DYNJ63057F ;   30) PERI GYN, Pack Number DYNJ64239B ;   31) OB GYN PACK , Pack Number DYNJ80831;   32) MON OB GYN PACK , Pack Number DYNJ80831A ;   33) MON OB GYN PACK , Pack Number DYNJ80831B ;   34) LAP PELVISCOPY PACK , Pack Number DYNJ82449;   35) PELVISCOPY PACK , Pack Number DYNJ82555;   36) PELVISCOPY PACK , Pack Number DYNJ82555A ;   37) PELVISCOPY, Pack Number DYNJ82676;   38) PERIPELVIC PACK , Pack Number DYNJ83912;   39) PELVISCOPY PACK , Pack Number DYNJ84379;   40) PELVISCOPY PACK , Pack Number DYNJ85311;   41) D-PELVISCOPY, Pack Number DYNJ900628I;   42) PELVISCOPY, Pack Number DYNJ901655F;   43) PELVISCOPY, Pack Number DYNJ901655G;   44) PELVISCOPY, Pack Number DYNJ908446B;   45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A;   46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B (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-3045-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:    1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ;   2) GROTH PELVISCOPY, Pack Number CDS984187U ;   3) DERMATOLOGY KIT, Pack Number DYNDA1567D;   4) ER MINOR SUTURE SET, Pack Number DYNDA1977A;   5) HSG TRAY, Pack Number DYNDH1453;   6) TRAY, ER LACERATION, Pack Number DYNDL1569A;   7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ;   8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ;   9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ;   10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ;   11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ;   12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ;   13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ;   14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ;   15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ;   16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ;   17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ;   18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ;   19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ;   20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ;   21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ;   22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ;   23) PELVISCOPY PACK , Pack Number DYNJ50688D ;   24) PELVISCOPY PACK , Pack Number DYNJ50688F ;   25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ;   26) PELVIC LAP, Pack Number DYNJ53601G ;   27) VAGINAL PACK, Pack Number DYNJ59786B ;   28) PELVIC PACK , Pack Number DYNJ63057D ;   29) PELVIC PACK , Pack Number DYNJ63057F ;   30) PERI GYN, Pack Number DYNJ64239B ;   31) OB GYN PACK , Pack Number DYNJ80831;   32) MON OB GYN PACK , Pack Number DYNJ80831A ;   33) MON OB GYN PACK , Pack Number DYNJ80831B ;   34) LAP PELVISCOPY PACK , Pack Number DYNJ82449;   35) PELVISCOPY PACK , Pack Number DYNJ82555;   36) PELVISCOPY PACK , Pack Number DYNJ82555A ;   37) PELVISCOPY, Pack Number DYNJ82676;   38) PERIPELVIC PACK , Pack Number DYNJ83912;   39) PELVISCOPY PACK , Pack Number DYNJ84379;   40) PELVISCOPY PACK , Pack Number DYNJ85311;   41) D-PELVISCOPY, Pack Number DYNJ900628I;   42) PELVISCOPY, Pack Number DYNJ901655F;   43) PELVISCOPY, Pack Number DYNJ901655G;   44) PELVISCOPY, Pack Number DYNJ908446B;   45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A;   46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3045-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3045-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ;   2) GROTH PELVISCOPY, Pack Number CDS984187U ;   3) DERMATOLOGY KIT, Pack Number DYNDA1567D;   4) ER MINOR SUTURE SET, Pack Number DYNDA1977A;   5) HSG TRAY, Pack Number DYNDH1453;   6) TRAY, ER LACERATION, Pack Number DYNDL1569A;   7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ;   8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ;   9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ;   10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ;   11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ;   12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ;   13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ;   14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ;   15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ;   16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ;   17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ;   18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ;   19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ;   20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ;   21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ;   22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ;   23) PELVISCOPY PACK , Pack Number DYNJ50688D ;   24) PELVISCOPY PACK , Pack Number DYNJ50688F ;   25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ;   26) PELVIC LAP, Pack Number DYNJ53601G ;   27) VAGINAL PACK, Pack Number DYNJ59786B ;   28) PELVIC PACK , Pack Number DYNJ63057D ;   29) PELVIC PACK , Pack Number DYNJ63057F ;   30) PERI GYN, Pack Number DYNJ64239B ;   31) OB GYN PACK , Pack Number DYNJ80831;   32) MON OB GYN PACK , Pack Number DYNJ80831A ;   33) MON OB GYN PACK , Pack Number DYNJ80831B ;   34) LAP PELVISCOPY PACK , Pack Number DYNJ82449;   35) PELVISCOPY PACK , Pack Number DYNJ82555;   36) PELVISCOPY PACK , Pack Number DYNJ82555A ;   37) PELVISCOPY, Pack Number DYNJ82676;   38) PERIPELVIC PACK , Pack Number DYNJ83912;   39) PELVISCOPY PACK , Pack Number DYNJ84379;   40) PELVISCOPY PACK , Pack Number DYNJ85311;   41) D-PELVISCOPY, Pack Number DYNJ900628I;   42) PELVISCOPY, Pack Number DYNJ901655F;   43) PELVISCOPY, Pack Number DYNJ901655G;   44) PELVISCOPY, Pack Number DYNJ908446B;   45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A;   46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B",
      "text": "The FDA logged enforcement record Z-3045-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:    1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ;   2) GROTH PELVISCOPY, Pack Number CDS984187U ;   3) DERMATOLOGY KIT, Pack Number DYNDA1567D;   4) ER MINOR SUTURE SET, Pack Number DYNDA1977A;   5) HSG TRAY, Pack Number DYNDH1453;   6) TRAY, ER LACERATION, Pack Number DYNDL1569A;   7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ;   8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ;   9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ;   10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ;   11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ;   12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ;   13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ;   14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ;   15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ;   16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ;   17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ;   18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ;   19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ;   20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ;   21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ;   22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ;   23) PELVISCOPY PACK , Pack Number DYNJ50688D ;   24) PELVISCOPY PACK , Pack Number DYNJ50688F ;   25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ;   26) PELVIC LAP, Pack Number DYNJ53601G ;   27) VAGINAL PACK, Pack Number DYNJ59786B ;   28) PELVIC PACK , Pack Number DYNJ63057D ;   29) PELVIC PACK , Pack Number DYNJ63057F ;   30) PERI GYN, Pack Number DYNJ64239B ;   31) OB GYN PACK , Pack Number DYNJ80831;   32) MON OB GYN PACK , Pack Number DYNJ80831A ;   33) MON OB GYN PACK , Pack Number DYNJ80831B ;   34) LAP PELVISCOPY PACK , Pack Number DYNJ82449;   35) PELVISCOPY PACK , Pack Number DYNJ82555;   36) PELVISCOPY PACK , Pack Number DYNJ82555A ;   37) PELVISCOPY, Pack Number DYNJ82676;   38) PERIPELVIC PACK , Pack Number DYNJ83912;   39) PELVISCOPY PACK , Pack Number DYNJ84379;   40) PELVISCOPY PACK , Pack Number DYNJ85311;   41) D-PELVISCOPY, Pack Number DYNJ900628I;   42) PELVISCOPY, Pack Number DYNJ901655F;   43) PELVISCOPY, Pack Number DYNJ901655G;   44) PELVISCOPY, Pack Number DYNJ908446B;   45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A;   46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B — 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: CDS984187T , Lot Number 22JBX647 ;  CDS984187T , Lot Number 22KBH092 ;  CDS984187T , Lot Number 22KBN639 ;  CDS984187T , Lot Number 23ABJ847 ;  CDS984187T , Lot Number 23DBN636 ;  CDS984187T , Lot Number 23EBN741 ;  CDS984187T , Lot Number 23FBO660 ;  CDS984187U , Lot Number 23GBV733 ;  CDS984187U , Lot Number 23HBA604 ;  CDS984187U , Lot Number 23JBE143 ;  CDS984187U , Lot Number 23JBE436 ;  CDS984187U , Lot Number 23JBX523 ;  CDS984187U , Lot Number 23LBN764 ;  CDS984187U , Lot Number 24BBN238 ;  CDS984187U , Lot Number 24BBU609 ;  DYNDA1567D, Lot Number 2019071090;  DYNDA1977A, Lot Number 2019071090;  DYNDH1453, Lot Number 2019071090;  DYNDL1569A, Lot Number 2019071090;  DYNJ0157511K , Lot Number 23LMI154 ;  DYNJ0161619I , Lot Number 23EMI816 ;  DYNJ0161619I , Lot Number 23FMC245 ;  DYNJ0161619I , Lot Number 23FMI370 ;  DYNJ0161619I , Lot Number 23HMB229 ;  DYNJ0161619I , Lot Number 23KMC793 ;  DYNJ0161619I , Lot Number 23KMF807 ;  DYNJ0477038K , Lot Number 23CBW969 ;  DYNJ0477038K , Lot Number 23EBW988 ;  DYNJ0477038K , Lot Number 23HBA845 ;  DYNJ0477038K , Lot Number 23IBP147 ;  DYNJ0477038K , Lot Number 23LBE881 ;  DYNJ0531985R , Lot Number 22HMF853 ;  DYNJ0531985R , Lot Number 22LMG691 ;  DYNJ0531985R , Lot Number 23AMF501 ;  DYNJ0531985R , Lot Number 23CMA603 ;  DYNJ0531985R , Lot Number 23DMG508 ;  DYNJ0537705L , Lot Number 23FMG696 ;  DYNJ0537705L , Lot Number 23IMC689 ;  DYNJ0780009W , Lot Number 22HMF696 ;  DYNJ0780009W , Lot Number 22JME002 ;  DYNJ0780009Y , Lot Number 23EMB610 ;  DYNJ0780009Y , Lot Number 23EMI825 ;  DYNJ0780009Y , Lot Number 23FMA234 ;  DYNJ0780009Y , Lot Number 23HMC653 ;  DYNJ0780009Y , Lot Number 23JMB180 ;  DYNJ0780009Y , Lot Number 23JMI648 ;  DYNJ0843760I , Lot Number 23DDA645 ;  DYNJ0843760I , Lot Number 23EDA680 ;  DYNJ0843760J , Lot Number 23JDA821 ;  DYNJ40099B , Lot Number 22ABP008 ;  DYNJ40099B , Lot Number 22BBW136 ;  DYNJ40099C , Lot Number 22FMB339 ;  DYNJ40099C , Lot Number 22HMA727 ;  DYNJ40099C , Lot Number 22IMG228 ;  DYNJ40099C , Lot Number 23BMG958 ;  DYNJ40099C , Lot Number 23BMH600 ;  DYNJ40099C , Lot Number 23DMD083 ;  DYNJ40099C , Lot Number 23DMG556 ;  DYNJ40099C , Lot Number 23FMJ765 ;  DYNJ40099C , Lot Number 23IMG857 ;  DYNJ40099C , Lot Number 23KMJ168 ;  DYNJ40099C , Lot Number 23LME309 ;  DYNJ40608D , Lot Number 23GBL162 ;  DYNJ40608D , Lot Number 23HBP723 ;  DYNJ40608D , Lot Number 23KBF077 ;  DYNJ40608D , Lot Number 23LBF535 ;  DYNJ47595N , Lot Number 23CMD083 ;  DYNJ47595O , Lot Number 23FMF971 ;  DYNJ47595P , Lot Number 23JMC128 ;  DYNJ47703G , Lot Number 23HME411 ;  DYNJ50688D , Lot Number 21HMG928 ;  DYNJ50688D , Lot Number 21HMH101 ;  DYNJ50688D , Lot Number 22AMG373 ;  DYNJ50688F , Lot Number 22HMH924 ;  DYNJ50688F , Lot Number 22KMC285 ;  DYNJ50688F , Lot Number 23EMA056 ;  DYNJ50688F , Lot Number 23GMF859 ;  DYNJ51918D , Lot Number 22IMA468 ;  DYNJ51918D , Lot Number 22KMB312 ;  DYNJ51918D , Lot Number 23AMA366 ;  DYNJ51918D , Lot Number 23DMG134 ;  DYNJ51918D , Lot Number 23HMI850 ;  DYNJ51918D , Lot Number 23IMC261 ;  DYNJ53601G , Lot Number 23HME948 ;  DYNJ53601G , Lot Number 23KMG377 ;  DYNJ59786B , Lot Number 21KMB136 ;  DYNJ59786B , Lot Number 22AME269 ;  DYNJ59786B , Lot Number 22DMF348 ;  DYNJ59786B , Lot Number 22EMF415 ;  DYNJ59786B , Lot Number 22FMB585 ;  DYNJ59786B , Lot Number 22GMG722 ;  DYNJ59786B , Lot Number 22IMG806 ;  DYNJ59786B , Lot Number 23AMH416 ;  DYNJ59786B , Lot Number 23DMC700 ;  DYNJ59786B , Lot Number 23EMF594 ;  DYNJ59786B , Lot Number 23EMK224 ;  DYNJ59786B , Lot Number 23FMD759 ;  DYNJ59786B , Lot Number 23FMI823 ;  DYNJ59786B , Lot Number 23GMG644 ;  DYNJ59786B , Lot Number 23JMG306 ;  DYNJ63057D , Lot Number 22HMB872 ;  DYNJ63057D , Lot Number 22JMC857 ;  DYNJ63057D , Lot Number 22KMD431 ;  DYNJ63057D , Lot Number 23CMC877 ;  DYNJ63057D , Lot Number 23EMB169 ;  DYNJ63057D , Lot Number 23GMF137 ;  DYNJ63057D , Lot Number 23HME622 ;  DYNJ63057D , Lot Number 23HMH140 ;  DYNJ63057F , Lot Number 23JMB899 ;  DYNJ64239B , Lot Number 23JMB243 ;  DYNJ80831, Lot Number 22BBE492 ;  DYNJ80831A , Lot Number 22EBH171 ;  DYNJ80831A , Lot Number 22FBD558 ;  DYNJ80831A , Lot Number 22HBD454 ;  DYNJ80831A , Lot Number 22IBL749 ;  DYNJ80831A , Lot Number 22KBP279 ;  DYNJ80831A , Lot Number 23BBB408 ;  DYNJ80831A , Lot Number 23CBP926 ;  DYNJ80831A , Lot Number 23DBC253 ;  DYNJ80831A , Lot Number 23EBJ251 ;  DYNJ80831A , Lot Number 23FBG917 ;  DYNJ80831B , Lot Number 23HBD666 ;  DYNJ80831B , Lot Number 23IBN212 ;  DYNJ80831B , Lot Number 23LBR042 ;  DYNJ82449, Lot Number 22HBJ902 ;  DYNJ82449, Lot Number 22LBD452 ;  DYNJ82449, Lot Number 23ABP213 ;  DYNJ82449, Lot Number 23EBO156 ;  DYNJ82449, Lot Number 23FBB975 ;  DYNJ82449, Lot Number 23FBC650 ;  DYNJ82449, Lot Number 23IBU101 ;  DYNJ82449, Lot Number 23JBL107 ;  DYNJ82449, Lot Number 24ABD321 ;  DYNJ82555, Lot Number 22HBQ035 ;  DYNJ82555, Lot Number 22KBI309 ;  DYNJ82555, Lot Number 22KBP238 ;  DYNJ82555, Lot Number 22LBF636 ;  DYNJ82555, Lot Number 23CBT455 ;  DYNJ82555, Lot Number 23DBP026 ; 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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
      },
      "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-3045-2024&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-3045-2024&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-3045-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3045-2024 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",
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      "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-3045-2024&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-3045-2024&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-3045-2024/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",
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      "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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            "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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