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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1418-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience Kits:  1) HYSTEROSCOPY, Model Number: CDS984086I;   2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A;   3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J;   4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K;   5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R;   6) VAG HYST PACK, Model Number: DYNJ31344J;   7) VAG HYST PACK, Model Number: DYNJ31344K;   8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L;   9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M;   10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N;   11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O;   12) LAVH PACK, Model Number: DYNJ36712F;   13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I;   14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C;   15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I;   16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B;   17) LAVH - N #668629 -N, Model Number: DYNJ58121C;   18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B;   19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G;   20) D AND C PACK, Model Number: DYNJ61282B;   21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161;   22) PERI GYN, Model Number: DYNJ67708A;   23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B;   24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C;   25) ANORECTAL PACK, Model Number: DYNJ83560;   26) D&C CDS, Model Number: DYNJ902560I;   27) HYSTEROSCOPY, Model Number: DYNJ903327K;   28) ROBOTIC HYST, Model Number: DYNJ903798G;   29) TLH KIT, Model Number: DYNJ908149;   30) LAVH TOTE, Model Number: DYNJ908340;   31) LAVH TOTE, Model Number: DYNJ908340A;   32) LAVH TOTE, Model Number: DYNJ908340B;   33) LAVH TOTE, Model Number: DYNJ908340D;   34) BRECKENRIDGE LAVH, Model Number: DYNJ910537;   35) VAG HYST PACK, Model Number: DYNJT3348;   36) LAVH PART B, Model Number: DYNJV0312G",
  "description": "FDA recall Z-1418-2026 — Medline Industries, LP is recalling Medline Convenience Kits:  1) HYSTEROSCOPY, Model Number: CDS984086I;   2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A;   3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J;   4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K;   5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R;   6) VAG HYST PACK, Model Number: DYNJ31344J;   7) VAG HYST PACK, Model Number: DYNJ31344K;   8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L;   9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M;   10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N;   11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O;   12) LAVH PACK, Model Number: DYNJ36712F;   13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I;   14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C;   15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I;   16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B;   17) LAVH - N #668629 -N, Model Number: DYNJ58121C;   18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B;   19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G;   20) D AND C PACK, Model Number: DYNJ61282B;   21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161;   22) PERI GYN, Model Number: DYNJ67708A;   23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B;   24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C;   25) ANORECTAL PACK, Model Number: DYNJ83560;   26) D&C CDS, Model Number: DYNJ902560I;   27) HYSTEROSCOPY, Model Number: DYNJ903327K;   28) ROBOTIC HYST, Model Number: DYNJ903798G;   29) TLH KIT, Model Number: DYNJ908149;   30) LAVH TOTE, Model Number: DYNJ908340;   31) LAVH TOTE, Model Number: DYNJ908340A;   32) LAVH TOTE, Model Number: DYNJ908340B;   33) LAVH TOTE, Model Number: DYNJ908340D;   34) BRECKENRIDGE LAVH, Model Number: DYNJ910537;   35) VAG HYST PACK, Model Number: DYNJT3348;   36) LAVH PART B, Model Number: DYNJV0312G (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-1418-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience Kits:  1) HYSTEROSCOPY, Model Number: CDS984086I;   2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A;   3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J;   4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K;   5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R;   6) VAG HYST PACK, Model Number: DYNJ31344J;   7) VAG HYST PACK, Model Number: DYNJ31344K;   8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L;   9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M;   10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N;   11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O;   12) LAVH PACK, Model Number: DYNJ36712F;   13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I;   14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C;   15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I;   16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B;   17) LAVH - N #668629 -N, Model Number: DYNJ58121C;   18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B;   19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G;   20) D AND C PACK, Model Number: DYNJ61282B;   21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161;   22) PERI GYN, Model Number: DYNJ67708A;   23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B;   24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C;   25) ANORECTAL PACK, Model Number: DYNJ83560;   26) D&C CDS, Model Number: DYNJ902560I;   27) HYSTEROSCOPY, Model Number: DYNJ903327K;   28) ROBOTIC HYST, Model Number: DYNJ903798G;   29) TLH KIT, Model Number: DYNJ908149;   30) LAVH TOTE, Model Number: DYNJ908340;   31) LAVH TOTE, Model Number: DYNJ908340A;   32) LAVH TOTE, Model Number: DYNJ908340B;   33) LAVH TOTE, Model Number: DYNJ908340D;   34) BRECKENRIDGE LAVH, Model Number: DYNJ910537;   35) VAG HYST PACK, Model Number: DYNJT3348;   36) LAVH PART B, Model Number: DYNJV0312G",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1418-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1418-2026: Medline Industries, LP is recalling Medline Convenience Kits:  1) HYSTEROSCOPY, Model Number: CDS984086I;   2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A;   3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J;   4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K;   5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R;   6) VAG HYST PACK, Model Number: DYNJ31344J;   7) VAG HYST PACK, Model Number: DYNJ31344K;   8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L;   9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M;   10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N;   11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O;   12) LAVH PACK, Model Number: DYNJ36712F;   13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I;   14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C;   15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I;   16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B;   17) LAVH - N #668629 -N, Model Number: DYNJ58121C;   18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B;   19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G;   20) D AND C PACK, Model Number: DYNJ61282B;   21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161;   22) PERI GYN, Model Number: DYNJ67708A;   23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B;   24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C;   25) ANORECTAL PACK, Model Number: DYNJ83560;   26) D&C CDS, Model Number: DYNJ902560I;   27) HYSTEROSCOPY, Model Number: DYNJ903327K;   28) ROBOTIC HYST, Model Number: DYNJ903798G;   29) TLH KIT, Model Number: DYNJ908149;   30) LAVH TOTE, Model Number: DYNJ908340;   31) LAVH TOTE, Model Number: DYNJ908340A;   32) LAVH TOTE, Model Number: DYNJ908340B;   33) LAVH TOTE, Model Number: DYNJ908340D;   34) BRECKENRIDGE LAVH, Model Number: DYNJ910537;   35) VAG HYST PACK, Model Number: DYNJT3348;   36) LAVH PART B, Model Number: DYNJV0312G",
      "text": "The FDA logged enforcement record Z-1418-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits:  1) HYSTEROSCOPY, Model Number: CDS984086I;   2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A;   3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J;   4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K;   5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R;   6) VAG HYST PACK, Model Number: DYNJ31344J;   7) VAG HYST PACK, Model Number: DYNJ31344K;   8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L;   9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M;   10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N;   11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O;   12) LAVH PACK, Model Number: DYNJ36712F;   13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I;   14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C;   15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I;   16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B;   17) LAVH - N #668629 -N, Model Number: DYNJ58121C;   18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B;   19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G;   20) D AND C PACK, Model Number: DYNJ61282B;   21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161;   22) PERI GYN, Model Number: DYNJ67708A;   23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B;   24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C;   25) ANORECTAL PACK, Model Number: DYNJ83560;   26) D&C CDS, Model Number: DYNJ902560I;   27) HYSTEROSCOPY, Model Number: DYNJ903327K;   28) ROBOTIC HYST, Model Number: DYNJ903798G;   29) TLH KIT, Model Number: DYNJ908149;   30) LAVH TOTE, Model Number: DYNJ908340;   31) LAVH TOTE, Model Number: DYNJ908340A;   32) LAVH TOTE, Model Number: DYNJ908340B;   33) LAVH TOTE, Model Number: DYNJ908340D;   34) BRECKENRIDGE LAVH, Model Number: DYNJ910537;   35) VAG HYST PACK, Model Number: DYNJT3348;   36) LAVH PART B, Model Number: DYNJV0312G — reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-07. Affected lots/codes: 1) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24CBQ563; 2) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24ABO363; 3) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23IBV204; 4) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23HBY878; 5) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23GBE705; 6) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23HBI773; 7) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBD256; 8) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBC116; 9) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBS135; 10) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBL440; 11) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH451; 12) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH032; 13) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH028; 14) DYNJ0373807J, UDI-DI: 10193489942996(each), 40193489942997(case), Lot Number: 22EBC904; 15) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22JBO175; 16) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22HBV873; 17) DYNJ27434R, UDI-DI: 10195327107727(each), 40195327107728(case), Lot Number: 23EBQ683; 18) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21LBL067; 19) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21CBJ513; 20) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21ABP592; 21) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 23CMG183; 22) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22KMC218; 23) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22CBV220; 24) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23EMG111; 25) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23BMG588; 26) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 22LME145; 27) DYNJ33393M, UDI-DI: 10195327567323(each), 40195327567324(case), Lot Number: 24AMC141; 28) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24LME743; 29) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24HMH344; 30) DYNJ33393O, UDI-DI: 10198459244537(each), 40198459244538(case), Lot Number: 25CMI389; 31) DYNJ36712F, UDI-DI: 10195327148027(each), 40195327148028(case), Lot Number: 22KBH638; 32) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23HBF942; 33) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23GBF010; 34) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23FBJ953; 35) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23DBD471; 36) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23BBC494; 37) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22GBK309; 38) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22EBK097; 39) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22BBZ962; 40) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22ABL203; 41) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 21LBI132; 42) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25LBE575; 43) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25DBK709; 44) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25ABN265; 45) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24JBI039; 46) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24GBV369; 47) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24FBC228; 48) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23JBH886; 49) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23IBV025; 50) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23HBR561; 51) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23FBO439; 52) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23EBL258; 53) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23DBQ854; 54) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22HBB055; 55) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22GBG579; 56) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22ABU361; 57) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21KBQ945; 58) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21HBS940; 59) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21DBN261; 60) DYNJ47694I, UDI-DI: 10195327437046(each), 40195327437047(case), Lot Number: 24GMI287; 61) DYNJ51741B, UDI-DI: 10193489538939(each), 40193489538930(case), Lot Number: 22BBC761; 62) DYNJ58121C, UDI-DI: 10195327312398(each), 40195327312399(case), Lot Number: 23GMH701; 63) DYNJ58121C, UDI-DI: 10195327312398(each), 40195327312399(case), Lot Number: 23EMA454; 64) DYNJ59037B, UDI-DI: 10193489948196(each), 40193489948197(case), Lot Number: 22GBI562; 65) DYNJ59444G, UDI-DI: 10193489431650(each), 40193489431651(case), Lot Number: 20LMF707; 66) DYNJ61282B, UDI-DI: 10195327054663(each), 40195327054664(case), Lot Number: 24ABY154; 67) DYNJ67161, UDI-DI: 10193489396744(each), 40193489396745(case), Lot Number: 22CBY767; 68) DYNJ67708A, UDI-DI: 10195327039899(each), 40195327039890(case), Lot Number: 23JBW724; 69) DYNJ69713B, UDI-DI: 10195327340513(each), 40195327340514(case), Lot Number: 23JBY129; 70) DYNJ69713C, UDI-DI: 10195327594633(each), 40195327594634(case), Lot Number: 24EBR875; 71) DYNJ83560, UDI-DI: 10195327280291(each), 40195327280292(case), Lot Number: 23BBB410; 72) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 23AMI329; 73) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22JMF106; 74) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22IMC843; 75) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22IMB138; 76) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 22HBB969; 77) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 22ABL216; 78) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21KBH136; 79) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21KBC695; 80) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21GBV717; 81) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21GBV715; 82) DYNJ903798G, UDI-DI: 10193489420036(each), 40193489420037(case), Lot Number: 23ABR411; 83) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23EBV901; 84) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23BBM781; 85) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23ABK510; 86) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23ABK509; 87) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 23CBD846; 88) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 23ABR402; 89) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 22HBS469; 90) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 22BBV448; 91) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23JBI674; 92) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23IBF567; 93) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23HBT696; 94) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23HBE358; 95) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23EBR451; 96) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 24BBV876; 97) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 24BBG247; 98) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 23LBF494; 99) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 25ABM341; 100) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24JBK180; 101) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24IBM046; 102) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24IBG486; 103) DYNJ910537, UDI-DI: 10198459029936(each), 40198459029937(case), Lot Number: 24GBX676; 104) DYNJT3348, UDI-DI: 10198459323751(each), 40198459323752(case), Lot Number: 25EBN202; 105) DYNJV0312G, UDI-DI: 10198459489051(each), 40198459489052(case), Lot Number: 25LME070. 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-1418-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1418-2026&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1418-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1418-2026 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1418-2026&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1418-2026&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1418-2026/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-1418-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1418-2026",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medline Industries, LP",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-01-07",
            "Status": "recorded"
          }
        },
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12) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH032; 13) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH028; 14) DYNJ0373807J, UDI-DI: 10193489942996(each), 40193489942997(case), Lot Number: 22EBC904; 15) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22JBO175; 16) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22HBV873; 17) DYNJ27434R, UDI-DI: 10195327107727(each), 40195327107728(case), Lot Number: 23EBQ683; 18) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21LBL067; 19) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21CBJ513; 20) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21ABP592; 21) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 23CMG183; 22) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22KMC218; 23) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22CBV220; 24) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23EMG111; 25) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23BMG588; 26) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 22LME145; 27) DYNJ33393M, UDI-DI: 10195327567323(each), 40195327567324(case), Lot Number: 24AMC141; 28) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24LME743; 29) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24HMH344; 30) DYNJ33393O, UDI-DI: 10198459244537(each), 40198459244538(case), Lot Number: 25CMI389; 31) DYNJ36712F, UDI-DI: 10195327148027(each), 40195327148028(case), Lot Number: 22KBH638; 32) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23HBF942; 33) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23GBF010; 34) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23FBJ953; 35) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23DBD471; 36) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23BBC494; 37) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22GBK309; 38) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22EBK097; 39) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22BBZ962; 40) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22ABL203; 41) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 21LBI132; 42) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25LBE575; 43) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25DBK709; 44) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25ABN265; 45) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24JBI039; 46) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24GBV369; 47) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24FBC228; 48) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23JBH886; 49) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23IBV025; 50) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23HBR561; 51) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23FBO439; 52) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23EBL258; 53) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23DBQ854; 54) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22HBB055; 55) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22GBG579; 56) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22ABU361; 57) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21KBQ945; 58) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21HBS940; 59) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21DBN261; 60) DYNJ47694I, UDI-DI: 10195327437046(each), 40195327437047(case), Lot Number: 24GMI287; 61) DYNJ51741B, UDI-DI: 10193489538939(each), 40193489538930(case), Lot Number: 22BBC761; 62) DYNJ58121C, UDI-DI: 10195327312398(each), 40195327312399(case), Lot Number: 23GMH701; 63) DYNJ58121C, UDI-DI: 10195327312398(each), 40195327312399(case), Lot Number: 23EMA454; 64) DYNJ59037B, UDI-DI: 10193489948196(each), 40193489948197(case), Lot Number: 22GBI562; 65) DYNJ59444G, UDI-DI: 10193489431650(each), 40193489431651(case), Lot Number: 20LMF707; 66) DYNJ61282B, UDI-DI: 10195327054663(each), 40195327054664(case), Lot Number: 24ABY154; 67) DYNJ67161, UDI-DI: 10193489396744(each), 40193489396745(case), Lot Number: 22CBY767; 68) DYNJ67708A, UDI-DI: 10195327039899(each), 40195327039890(case), Lot Number: 23JBW724; 69) DYNJ69713B, UDI-DI: 10195327340513(each), 40195327340514(case), Lot Number: 23JBY129; 70) DYNJ69713C, UDI-DI: 10195327594633(each), 40195327594634(case), Lot Number: 24EBR875; 71) DYNJ83560, UDI-DI: 10195327280291(each), 40195327280292(case), Lot Number: 23BBB410; 72) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 23AMI329; 73) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22JMF106; 74) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22IMC843; 75) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22IMB138; 76) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 22HBB969; 77) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 22ABL216; 78) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21KBH136; 79) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21KBC695; 80) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21GBV717; 81) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21GBV715; 82) DYNJ903798G, UDI-DI: 10193489420036(each), 40193489420037(case), Lot Number: 23ABR411; 83) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23EBV901; 84) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23BBM781; 85) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23ABK510; 86) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23ABK509; 87) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 23CBD846; 88) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 23ABR402; 89) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 22HBS469; 90) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 22BBV448; 91) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23JBI674; 92) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23IBF567; 93) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23HBT696; 94) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23HBE358; 95) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23EBR451; 96) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 24BBV876; 97) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 24BBG247; 98) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 23LBF494; 99) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 25ABM341; 100) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24JBK180; 101) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24IBM046; 102) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24IBG486; 103) DYNJ910537, UDI-DI: 10198459029936(each), 40198459029937(case), Lot Number: 24GBX676; 104) DYNJT3348, UDI-DI: 10198459323751(each), 40198459323752(case), Lot Number: 25EBN202; 105) DYNJV0312G, UDI-DI: 10198459489051(each), 40198459489052(case), Lot Number: 25LME070",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}