{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1611-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits used for various procedures:  1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L;   2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P;   3) VUWC OB PACK, Model Number: DYNJ64017B;   4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   5) PACK VAGINAL DELIVERY, Model Number: HM190A;   6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B;   7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B;   9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C;   10) VAGINAL DEL PK, Model Number: DYNJ65689;   11) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   12) L&D PACK-LF, Model Number: DYNJ0731657M;   13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B;   14) VAD ACCESS, Model Number: DYNJ24276C;   15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304;   16) VAGINAL DELIVERY CDS, Model Number: CDS982762I;   17) VAGINAL DELIVERY, Model Number: DYNJ903796C;   18) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D;   19) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D;   20) BR L&D PACK, Model Number: DYNJ47625B;   21) OB PACK, Model Number: DYNJ03387B;   22) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   23) VAGINAL DELIVERY TRAY, Model Number: MNS7460A;   24) VAGINAL DELIVERY PACK, Model Number: DYNJ23158B;   25) L AND D PACK, Model Number: DYNJHTLD03A;   26) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   27) VAG DELIVERY PACK, Model Number: DYNJ34949;   28) OB PACK, Model Number: DYNJ55835B;   29) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A;   30) OB PACK, Model Number: DYNJ83115;   31) VAGINAL DEL PK, Model Number: DYNJ65689;   32) LDRP-OBSTETRICAL PACK-LF, Model Number: DYNJ64828B;   33) LABOR & DELIVERY PACK, Model Number: DYNJ69433;   34) LABOR & DELIVERY II-LF, Model Number: DYNJS8250;   35) VAGINAL DELIVERY PACK-MARY IMM, Model Number: DYNJ24514G;   36) CUSTOM VAGINAL DELIVERY, Model Number: DYNJ63270C;   37) BHS STANDARD VAGINAL DELIVERY, Model Number: DYNJ80329;   38) OB VAGINAL PACK-LF, Model Number: DYNJ40009D;   39) DELIVERY PACK ME-LF RF, Model Number: DYNJ45589F;   40) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ82620A;   41) VAGINAL DELIVERY, Model Number: DYNJ903796C;   42) DELIVERY PACK, Model Number: DYNJ69964;   43) VAGINAL DELIVERY PACK, Model Number: DYNJ34315D;   44) VAGINAL DELIVERY PACK, Model Number: DYNJ57668A;   45) VAG DELIVERY PACK CHS-LF, Model Number: DYNJ35608K;   46) O.B. PACK-LF, Model Number: DYNJ07520J;   47) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   48) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A;   49) CUH VAGINAL-LF, Model Number: DYNJC9242C;   50) VAGINAL DELIVERY, Model Number: DYNJ903796C;   51) VAGINAL DELIVERY, Model Number: DYNJ907958;   52) VAG DEL PROCEDURE MCSETX, Model Number: DYNJ908581A;   53) CUH VAGINAL-LF, Model Number: DYNJC9242C;   54) VAGINAL DELIVERY, Model Number: DYNJ903796C;   55) VAGINAL DELIVERY, Model Number: DYNJ907958",
  "description": "FDA recall Z-1611-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits used for various procedures:  1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L;   2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P;   3) VUWC OB PACK, Model Number: DYNJ64017B;   4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   5) PACK VAGINAL DELIVERY, Model Number: HM190A;   6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B;   7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B;   9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C;   10) VAGINAL DEL PK, Model Number: DYNJ65689;   11) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   12) L&D PACK-LF, Model Number: DYNJ0731657M;   13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B;   14) VAD ACCESS, Model Number: DYNJ24276C;   15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304;   16) VAGINAL DELIVERY CDS, Model Number: CDS982762I;   17) VAGINAL DELIVERY, Model Number: DYNJ903796C;   18) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D;   19) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D;   20) BR L&D PACK, Model Number: DYNJ47625B;   21) OB PACK, Model Number: DYNJ03387B;   22) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   23) VAGINAL DELIVERY TRAY, Model Number: MNS7460A;   24) VAGINAL DELIVERY PACK, Model Number: DYNJ23158B;   25) L AND D PACK, Model Number: DYNJHTLD03A;   26) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   27) VAG DELIVERY PACK, Model Number: DYNJ34949;   28) OB PACK, Model Number: DYNJ55835B;   29) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A;   30) OB PACK, Model Number: DYNJ83115;   31) VAGINAL DEL PK, Model Number: DYNJ65689;   32) LDRP-OBSTETRICAL PACK-LF, Model Number: DYNJ64828B;   33) LABOR & DELIVERY PACK, Model Number: DYNJ69433;   34) LABOR & DELIVERY II-LF, Model Number: DYNJS8250;   35) VAGINAL DELIVERY PACK-MARY IMM, Model Number: DYNJ24514G;   36) CUSTOM VAGINAL DELIVERY, Model Number: DYNJ63270C;   37) BHS STANDARD VAGINAL DELIVERY, Model Number: DYNJ80329;   38) OB VAGINAL PACK-LF, Model Number: DYNJ40009D;   39) DELIVERY PACK ME-LF RF, Model Number: DYNJ45589F;   40) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ82620A;   41) VAGINAL DELIVERY, Model Number: DYNJ903796C;   42) DELIVERY PACK, Model Number: DYNJ69964;   43) VAGINAL DELIVERY PACK, Model Number: DYNJ34315D;   44) VAGINAL DELIVERY PACK, Model Number: DYNJ57668A;   45) VAG DELIVERY PACK CHS-LF, Model Number: DYNJ35608K;   46) O.B. PACK-LF, Model Number: DYNJ07520J;   47) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   48) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A;   49) CUH VAGINAL-LF, Model Number: DYNJC9242C;   50) VAGINAL DELIVERY, Model Number: DYNJ903796C;   51) VAGINAL DELIVERY, Model Number: DYNJ907958;   52) VAG DEL PROCEDURE MCSETX, Model Number: DYNJ908581A;   53) CUH VAGINAL-LF, Model Number: DYNJC9242C;   54) VAGINAL DELIVERY, Model Number: DYNJ903796C;   55) VAGINAL DELIVERY, Model Number: DYNJ907958 (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-1611-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits used for various procedures:  1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L;   2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P;   3) VUWC OB PACK, Model Number: DYNJ64017B;   4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   5) PACK VAGINAL DELIVERY, Model Number: HM190A;   6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B;   7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B;   9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C;   10) VAGINAL DEL PK, Model Number: DYNJ65689;   11) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   12) L&D PACK-LF, Model Number: DYNJ0731657M;   13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B;   14) VAD ACCESS, Model Number: DYNJ24276C;   15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304;   16) VAGINAL DELIVERY CDS, Model Number: CDS982762I;   17) VAGINAL DELIVERY, Model Number: DYNJ903796C;   18) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D;   19) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D;   20) BR L&D PACK, Model Number: DYNJ47625B;   21) OB PACK, Model Number: DYNJ03387B;   22) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   23) VAGINAL DELIVERY TRAY, Model Number: MNS7460A;   24) VAGINAL DELIVERY PACK, Model Number: DYNJ23158B;   25) L AND D PACK, Model Number: DYNJHTLD03A;   26) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   27) VAG DELIVERY PACK, Model Number: DYNJ34949;   28) OB PACK, Model Number: DYNJ55835B;   29) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A;   30) OB PACK, Model Number: DYNJ83115;   31) VAGINAL DEL PK, Model Number: DYNJ65689;   32) LDRP-OBSTETRICAL PACK-LF, Model Number: DYNJ64828B;   33) LABOR & DELIVERY PACK, Model Number: DYNJ69433;   34) LABOR & DELIVERY II-LF, Model Number: DYNJS8250;   35) VAGINAL DELIVERY PACK-MARY IMM, Model Number: DYNJ24514G;   36) CUSTOM VAGINAL DELIVERY, Model Number: DYNJ63270C;   37) BHS STANDARD VAGINAL DELIVERY, Model Number: DYNJ80329;   38) OB VAGINAL PACK-LF, Model Number: DYNJ40009D;   39) DELIVERY PACK ME-LF RF, Model Number: DYNJ45589F;   40) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ82620A;   41) VAGINAL DELIVERY, Model Number: DYNJ903796C;   42) DELIVERY PACK, Model Number: DYNJ69964;   43) VAGINAL DELIVERY PACK, Model Number: DYNJ34315D;   44) VAGINAL DELIVERY PACK, Model Number: DYNJ57668A;   45) VAG DELIVERY PACK CHS-LF, Model Number: DYNJ35608K;   46) O.B. PACK-LF, Model Number: DYNJ07520J;   47) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   48) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A;   49) CUH VAGINAL-LF, Model Number: DYNJC9242C;   50) VAGINAL DELIVERY, Model Number: DYNJ903796C;   51) VAGINAL DELIVERY, Model Number: DYNJ907958;   52) VAG DEL PROCEDURE MCSETX, Model Number: DYNJ908581A;   53) CUH VAGINAL-LF, Model Number: DYNJC9242C;   54) VAGINAL DELIVERY, Model Number: DYNJ903796C;   55) VAGINAL DELIVERY, Model Number: DYNJ907958",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1611-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1611-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits used for various procedures:  1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L;   2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P;   3) VUWC OB PACK, Model Number: DYNJ64017B;   4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   5) PACK VAGINAL DELIVERY, Model Number: HM190A;   6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B;   7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B;   9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C;   10) VAGINAL DEL PK, Model Number: DYNJ65689;   11) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   12) L&D PACK-LF, Model Number: DYNJ0731657M;   13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B;   14) VAD ACCESS, Model Number: DYNJ24276C;   15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304;   16) VAGINAL DELIVERY CDS, Model Number: CDS982762I;   17) VAGINAL DELIVERY, Model Number: DYNJ903796C;   18) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D;   19) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D;   20) BR L&D PACK, Model Number: DYNJ47625B;   21) OB PACK, Model Number: DYNJ03387B;   22) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   23) VAGINAL DELIVERY TRAY, Model Number: MNS7460A;   24) VAGINAL DELIVERY PACK, Model Number: DYNJ23158B;   25) L AND D PACK, Model Number: DYNJHTLD03A;   26) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   27) VAG DELIVERY PACK, Model Number: DYNJ34949;   28) OB PACK, Model Number: DYNJ55835B;   29) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A;   30) OB PACK, Model Number: DYNJ83115;   31) VAGINAL DEL PK, Model Number: DYNJ65689;   32) LDRP-OBSTETRICAL PACK-LF, Model Number: DYNJ64828B;   33) LABOR & DELIVERY PACK, Model Number: DYNJ69433;   34) LABOR & DELIVERY II-LF, Model Number: DYNJS8250;   35) VAGINAL DELIVERY PACK-MARY IMM, Model Number: DYNJ24514G;   36) CUSTOM VAGINAL DELIVERY, Model Number: DYNJ63270C;   37) BHS STANDARD VAGINAL DELIVERY, Model Number: DYNJ80329;   38) OB VAGINAL PACK-LF, Model Number: DYNJ40009D;   39) DELIVERY PACK ME-LF RF, Model Number: DYNJ45589F;   40) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ82620A;   41) VAGINAL DELIVERY, Model Number: DYNJ903796C;   42) DELIVERY PACK, Model Number: DYNJ69964;   43) VAGINAL DELIVERY PACK, Model Number: DYNJ34315D;   44) VAGINAL DELIVERY PACK, Model Number: DYNJ57668A;   45) VAG DELIVERY PACK CHS-LF, Model Number: DYNJ35608K;   46) O.B. PACK-LF, Model Number: DYNJ07520J;   47) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   48) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A;   49) CUH VAGINAL-LF, Model Number: DYNJC9242C;   50) VAGINAL DELIVERY, Model Number: DYNJ903796C;   51) VAGINAL DELIVERY, Model Number: DYNJ907958;   52) VAG DEL PROCEDURE MCSETX, Model Number: DYNJ908581A;   53) CUH VAGINAL-LF, Model Number: DYNJC9242C;   54) VAGINAL DELIVERY, Model Number: DYNJ903796C;   55) VAGINAL DELIVERY, Model Number: DYNJ907958",
      "text": "The FDA logged enforcement record Z-1611-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits used for various procedures:  1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L;   2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P;   3) VUWC OB PACK, Model Number: DYNJ64017B;   4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   5) PACK VAGINAL DELIVERY, Model Number: HM190A;   6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B;   7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B;   9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C;   10) VAGINAL DEL PK, Model Number: DYNJ65689;   11) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   12) L&D PACK-LF, Model Number: DYNJ0731657M;   13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B;   14) VAD ACCESS, Model Number: DYNJ24276C;   15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304;   16) VAGINAL DELIVERY CDS, Model Number: CDS982762I;   17) VAGINAL DELIVERY, Model Number: DYNJ903796C;   18) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D;   19) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D;   20) BR L&D PACK, Model Number: DYNJ47625B;   21) OB PACK, Model Number: DYNJ03387B;   22) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   23) VAGINAL DELIVERY TRAY, Model Number: MNS7460A;   24) VAGINAL DELIVERY PACK, Model Number: DYNJ23158B;   25) L AND D PACK, Model Number: DYNJHTLD03A;   26) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   27) VAG DELIVERY PACK, Model Number: DYNJ34949;   28) OB PACK, Model Number: DYNJ55835B;   29) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A;   30) OB PACK, Model Number: DYNJ83115;   31) VAGINAL DEL PK, Model Number: DYNJ65689;   32) LDRP-OBSTETRICAL PACK-LF, Model Number: DYNJ64828B;   33) LABOR & DELIVERY PACK, Model Number: DYNJ69433;   34) LABOR & DELIVERY II-LF, Model Number: DYNJS8250;   35) VAGINAL DELIVERY PACK-MARY IMM, Model Number: DYNJ24514G;   36) CUSTOM VAGINAL DELIVERY, Model Number: DYNJ63270C;   37) BHS STANDARD VAGINAL DELIVERY, Model Number: DYNJ80329;   38) OB VAGINAL PACK-LF, Model Number: DYNJ40009D;   39) DELIVERY PACK ME-LF RF, Model Number: DYNJ45589F;   40) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ82620A;   41) VAGINAL DELIVERY, Model Number: DYNJ903796C;   42) DELIVERY PACK, Model Number: DYNJ69964;   43) VAGINAL DELIVERY PACK, Model Number: DYNJ34315D;   44) VAGINAL DELIVERY PACK, Model Number: DYNJ57668A;   45) VAG DELIVERY PACK CHS-LF, Model Number: DYNJ35608K;   46) O.B. PACK-LF, Model Number: DYNJ07520J;   47) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   48) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A;   49) CUH VAGINAL-LF, Model Number: DYNJC9242C;   50) VAGINAL DELIVERY, Model Number: DYNJ903796C;   51) VAGINAL DELIVERY, Model Number: DYNJ907958;   52) VAG DEL PROCEDURE MCSETX, Model Number: DYNJ908581A;   53) CUH VAGINAL-LF, Model Number: DYNJC9242C;   54) VAGINAL DELIVERY, Model Number: DYNJ903796C;   55) VAGINAL DELIVERY, Model Number: DYNJ907958 — reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-03. Affected lots/codes: 1) DYNJ26971L, UDI-DI: 10198459087158(each), 40198459087159(case), Lot Number: 24IBD872; 2) DYNJ0378319P, UDI-DI: 10198459105722(each), 40198459105723(case), Lot Number: 24IBF374; 3) DYNJ64017B, UDI-DI: 10195327550325(each), 40195327550326(case), Lot Number: 24IBG070; 4) DYNJHTLD04A, UDI-DI: 10193489303346(each), 40193489303347(case), Lot Number: 24IBH288; 5) HM190A, UDI-DI: 10195327305161(each), 40195327305162(case), Lot Number: 24IBH818; 6) SYNJ10248B, UDI-DI: 10193489373387(each), 40193489373388(case), Lot Number: 24IBH820; 7) DYNJ84209, UDI-DI: 10195327342739(each), 40195327342730(case), Lot Number: 24IBH988; 8) DYNJ49542B, UDI-DI: 10195327388072(each), 40195327388073(case), Lot Number: 24IBR452; 9) DYNJ37124C, UDI-DI: 10195327416195(each), 40195327416196(case), Lot Number: 24IBR491; 10) DYNJ65689, UDI-DI: 10193489284836(each), 40193489284837(case), Lot Number: 24IBR570; 11) DYNJ43737D, UDI-DI: 10193489350845(each), 40193489350846(case), Lot Number: 24IBR650; 12) DYNJ0731657M, UDI-DI: 10195327697020(each), 40195327697021(case), Lot Number: 24IBR661; 13) DYNJ43604B, UDI-DI: 10193489997521(each), 40193489997522(case), Lot Number: 24IBR707; 14) DYNJ24276C, UDI-DI: 10884389431184(each), 40884389431185(case), Lot Number: 24IBS408; 15) DYNJ80304, UDI-DI: 10195327022532(each), 40195327022533(case), Lot Number: 24IBS686; 16) CDS982762I, UDI-DI: 10193489942095(each), 40193489942096(case), Lot Number: 24JBB609; 17) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24JBE762; 18) DYNJ43677D, UDI-DI: 10193489768589(each), 40193489768580(case), Lot Number: 24JBM324; 19) DYNJ43677D, UDI-DI: 10193489768589(each), 40193489768580(case), Lot Number: 24JBM600; 20) DYNJ47625B, UDI-DI: 10889942182589(each), 40889942182580(case), Lot Number: 24JBN320; 21) DYNJ03387B, UDI-DI: 10195327191092(each), 40195327191093(case), Lot Number: 24JBO026; 22) DYNJHTLD04A, UDI-DI: 10193489303346(each), 40193489303347(case), Lot Number: 24JBR630; 23) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24JBU227; 24) DYNJ23158B, UDI-DI: 10195327473891(each), 40195327473892(case), Lot Number: 24JBU459; 25) DYNJHTLD03A, UDI-DI: 10193489303353(each), 40193489303354(case), Lot Number: 24JBU555; 26) DYNJ43737D, UDI-DI: 10193489350845(each), 40193489350846(case), Lot Number: 24JBV052; 27) DYNJ34949, UDI-DI: 10884389403358(each), 40884389403359(case), Lot Number: 24JBV802; 28) DYNJ55835B, UDI-DI: 10195327319946(each), 40195327319947(case), Lot Number: 24JBV820; 29) DYNJ68778A, UDI-DI: 10198459035852(each), 40198459035853(case), Lot Number: 24JBV866; 30) DYNJ83115, UDI-DI: 10195327232979(each), 40195327232970(case), Lot Number: 24JBV884; 31) DYNJ65689, UDI-DI: 10193489284836(each), 40193489284837(case), Lot Number: 24JBW792; 32) DYNJ64828B, UDI-DI: 10198459140280(each), 40198459140281(case), Lot Number: 24JBX788; 33) DYNJ69433, UDI-DI: 10193489940985(each), 40193489940986(case), Lot Number: 24JBX797; 34) DYNJS8250, UDI-DI: 10884389349298(each), 40884389349299(case), Lot Number: 24KBA046; 35) DYNJ24514G, UDI-DI: 10193489893656(each), 40193489893657(case), Lot Number: 24KBA388; 36) DYNJ63270C, UDI-DI: 10193489862614(each), 40193489862615(case), Lot Number: 24KBB101; 37) DYNJ80329, UDI-DI: 10195327027193(each), 40195327027194(case), Lot Number: 24KBB586; 38) DYNJ40009D, UDI-DI: 10195327362362(each), 40195327362363(case), Lot Number: 24KBC597; 39) DYNJ45589F, UDI-DI: 10198459125904(each), 40198459125905(case), Lot Number: 24KBC628; 40) DYNJ82620A, UDI-DI: 10198459150081(each), 40198459150082(case), Lot Number: 24KBC810; 41) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24KBD009; 42) DYNJ69964, UDI-DI: 10195327000660(each), 40195327000661(case), Lot Number: 24KBE397; 43) DYNJ34315D, UDI-DI: 10198459168369(each), 40198459168360(case), Lot Number: 24KBF136; 44) DYNJ57668A, UDI-DI: 10193489795622(each), 40193489795623(case), Lot Number: 24KBG150; 45) DYNJ35608K, UDI-DI: 10195327099022(each), 40195327099023(case), Lot Number: 24KBG823; 46) DYNJ07520J, UDI-DI: 10198459015533(each), 40198459015534(case), Lot Number: 24KBG847; 47) DYNJ84209, UDI-DI: 10195327342739(each), 40195327342730(case), Lot Number: 24KBG879; 48) DYNJ68778A, UDI-DI: 10198459035852(each), 40198459035853(case), Lot Number: 24KBH870; 49) DYNJC9242C, UDI-DI: 10193489568882(each), 40193489568883(case), Lot Number: 24KBL933; 50) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24KBN086; 51) DYNJ907958, UDI-DI: 10193489949445(each), 40193489949446(case), Lot Number: 24KBQ773; 52) DYNJ908581A, UDI-DI: 10195327594664(each), 40195327594665(case), Lot Number: 24KBU702; 53) DYNJC9242C, UDI-DI: 10193489568882(each), 40193489568883(case), Lot Number: 24LBK538; 54) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24LBO942; 55) DYNJ907958, UDI-DI: 10193489949445(each), 40193489949446(case), Lot Number: 25ABA840. 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-1611-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1611-2025&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1611-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1611-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1611-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1611-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1611-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1611-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1611-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-03-03",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) DYNJ26971L, UDI-DI: 10198459087158(each), 40198459087159(case), Lot Number: 24IBD872; 2) DYNJ0378319P, UDI-DI: 10198459105722(each), 40198459105723(case), Lot Number: 24IBF374; 3) DYNJ64017B, UDI-DI: 10195327550325(each), 40195327550326(case), Lot Number: 24IBG070; 4) DYNJHTLD04A, UDI-DI: 10193489303346(each), 40193489303347(case), Lot Number: 24IBH288; 5) HM190A, UDI-DI: 10195327305161(each), 40195327305162(case), Lot Number: 24IBH818; 6) SYNJ10248B, UDI-DI: 10193489373387(each), 40193489373388(case), Lot Number: 24IBH820; 7) DYNJ84209, UDI-DI: 10195327342739(each), 40195327342730(case), Lot Number: 24IBH988; 8) DYNJ49542B, UDI-DI: 10195327388072(each), 40195327388073(case), Lot Number: 24IBR452; 9) DYNJ37124C, UDI-DI: 10195327416195(each), 40195327416196(case), Lot Number: 24IBR491; 10) DYNJ65689, UDI-DI: 10193489284836(each), 40193489284837(case), Lot Number: 24IBR570; 11) DYNJ43737D, UDI-DI: 10193489350845(each), 40193489350846(case), Lot Number: 24IBR650; 12) DYNJ0731657M, UDI-DI: 10195327697020(each), 40195327697021(case), Lot Number: 24IBR661; 13) DYNJ43604B, UDI-DI: 10193489997521(each), 40193489997522(case), Lot Number: 24IBR707; 14) DYNJ24276C, UDI-DI: 10884389431184(each), 40884389431185(case), Lot Number: 24IBS408; 15) DYNJ80304, UDI-DI: 10195327022532(each), 40195327022533(case), Lot Number: 24IBS686; 16) CDS982762I, UDI-DI: 10193489942095(each), 40193489942096(case), Lot Number: 24JBB609; 17) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24JBE762; 18) DYNJ43677D, UDI-DI: 10193489768589(each), 40193489768580(case), Lot Number: 24JBM324; 19) DYNJ43677D, UDI-DI: 10193489768589(each), 40193489768580(case), Lot Number: 24JBM600; 20) DYNJ47625B, UDI-DI: 10889942182589(each), 40889942182580(case), Lot Number: 24JBN320; 21) DYNJ03387B, UDI-DI: 10195327191092(each), 40195327191093(case), Lot Number: 24JBO026; 22) DYNJHTLD04A, UDI-DI: 10193489303346(each), 40193489303347(case), Lot Number: 24JBR630; 23) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24JBU227; 24) DYNJ23158B, UDI-DI: 10195327473891(each), 40195327473892(case), Lot Number: 24JBU459; 25) DYNJHTLD03A, UDI-DI: 10193489303353(each), 40193489303354(case), Lot Number: 24JBU555; 26) DYNJ43737D, UDI-DI: 10193489350845(each), 40193489350846(case), Lot Number: 24JBV052; 27) DYNJ34949, UDI-DI: 10884389403358(each), 40884389403359(case), Lot Number: 24JBV802; 28) DYNJ55835B, UDI-DI: 10195327319946(each), 40195327319947(case), Lot Number: 24JBV820; 29) DYNJ68778A, UDI-DI: 10198459035852(each), 40198459035853(case), Lot Number: 24JBV866; 30) DYNJ83115, UDI-DI: 10195327232979(each), 40195327232970(case), Lot Number: 24JBV884; 31) DYNJ65689, UDI-DI: 10193489284836(each), 40193489284837(case), Lot Number: 24JBW792; 32) DYNJ64828B, UDI-DI: 10198459140280(each), 40198459140281(case), Lot Number: 24JBX788; 33) DYNJ69433, UDI-DI: 10193489940985(each), 40193489940986(case), Lot Number: 24JBX797; 34) DYNJS8250, UDI-DI: 10884389349298(each), 40884389349299(case), Lot Number: 24KBA046; 35) DYNJ24514G, UDI-DI: 10193489893656(each), 40193489893657(case), Lot Number: 24KBA388; 36) DYNJ63270C, UDI-DI: 10193489862614(each), 40193489862615(case), Lot Number: 24KBB101; 37) DYNJ80329, UDI-DI: 10195327027193(each), 40195327027194(case), Lot Number: 24KBB586; 38) DYNJ40009D, UDI-DI: 10195327362362(each), 40195327362363(case), Lot Number: 24KBC597; 39) DYNJ45589F, UDI-DI: 10198459125904(each), 40198459125905(case), Lot Number: 24KBC628; 40) DYNJ82620A, UDI-DI: 10198459150081(each), 40198459150082(case), Lot Number: 24KBC810; 41) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24KBD009; 42) DYNJ69964, UDI-DI: 10195327000660(each), 40195327000661(case), Lot Number: 24KBE397; 43) DYNJ34315D, UDI-DI: 10198459168369(each), 40198459168360(case), Lot Number: 24KBF136; 44) DYNJ57668A, UDI-DI: 10193489795622(each), 40193489795623(case), Lot Number: 24KBG150; 45) DYNJ35608K, UDI-DI: 10195327099022(each), 40195327099023(case), Lot Number: 24KBG823; 46) DYNJ07520J, UDI-DI: 10198459015533(each), 40198459015534(case), Lot Number: 24KBG847; 47) DYNJ84209, UDI-DI: 10195327342739(each), 40195327342730(case), Lot Number: 24KBG879; 48) DYNJ68778A, UDI-DI: 10198459035852(each), 40198459035853(case), Lot Number: 24KBH870; 49) DYNJC9242C, UDI-DI: 10193489568882(each), 40193489568883(case), Lot Number: 24KBL933; 50) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24KBN086; 51) DYNJ907958, UDI-DI: 10193489949445(each), 40193489949446(case), Lot Number: 24KBQ773; 52) DYNJ908581A, UDI-DI: 10195327594664(each), 40195327594665(case), Lot Number: 24KBU702; 53) DYNJC9242C, UDI-DI: 10193489568882(each), 40193489568883(case), Lot Number: 24LBK538; 54) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24LBO942; 55) DYNJ907958, UDI-DI: 10193489949445(each), 40193489949446(case), Lot Number: 25ABA840",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}