{
  "@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-1397-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience Kits:  1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499;   2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C;   3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158;   4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170;   5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A;   6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B;   7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;   8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A;   9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B;   10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183;   11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A;   12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B;   13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A;   14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39;   15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A;   16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C;   17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46;   18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54;   19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69;   20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A;   21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B;   22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78;   23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A;   24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B;   25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84;   26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C;   27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G;   28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J;   29) BREAST PACK ASC-LF, Model Number: DYNJ36469I;   30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J;   31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F;   32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K;   33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M;   34) BREAST PACK, Model Number: DYNJ50957G;   35) PLASTICS BREAST PACK, Model Number: DYNJ55358G;   36) BHN IMPLANT PACK, Model Number: DYNJ56737A;   37) BREAST PACK, Model Number: DYNJ60210A;   38) PLASTICS PACK 2, Model Number: DYNJ64927F;   39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A;   40) BREAST IMPLANT PACK, Model Number: DYNJ69351;   41) BREAST/TUMMY PACK, Model Number: DYNJ83788;   42) HMSL PLASTICS, Model Number: DYNJ83884B;   43) CHEST/BREAST-LF, Model Number: DYNJ83950A;   44) CHEST/BREAST-LF, Model Number: DYNJ83950B;   45) FREE FLAP A DIRTY, Model Number: DYNJ86165;   46) MAJOR SURGERY PACK, Model Number: DYNJ86816;   47) BREAST REDUCTION PACK, Model Number: DYNJ87444;   48) OMF FREE FLAP, Model Number: DYNJ902005I;   49) BREAST CDS, Model Number: DYNJ902558G;   50) TRUNCAL CONTOURING, Model Number: DYNJ903555D;   51) TRUNCAL CONTOURING, Model Number: DYNJ903555F;   52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C;   53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A;   54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A;   55) FACELIFT, Model Number: DYNJ910462;   56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283;   57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417;   58) PLASTICS PACK-LF, Model Number: PHS806973G",
  "description": "FDA recall Z-1397-2026 — Medline Industries, LP is recalling Medline Convenience Kits:  1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499;   2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C;   3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158;   4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170;   5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A;   6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B;   7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;   8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A;   9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B;   10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183;   11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A;   12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B;   13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A;   14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39;   15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A;   16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C;   17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46;   18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54;   19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69;   20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A;   21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B;   22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78;   23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A;   24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B;   25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84;   26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C;   27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G;   28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J;   29) BREAST PACK ASC-LF, Model Number: DYNJ36469I;   30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J;   31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F;   32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K;   33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M;   34) BREAST PACK, Model Number: DYNJ50957G;   35) PLASTICS BREAST PACK, Model Number: DYNJ55358G;   36) BHN IMPLANT PACK, Model Number: DYNJ56737A;   37) BREAST PACK, Model Number: DYNJ60210A;   38) PLASTICS PACK 2, Model Number: DYNJ64927F;   39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A;   40) BREAST IMPLANT PACK, Model Number: DYNJ69351;   41) BREAST/TUMMY PACK, Model Number: DYNJ83788;   42) HMSL PLASTICS, Model Number: DYNJ83884B;   43) CHEST/BREAST-LF, Model Number: DYNJ83950A;   44) CHEST/BREAST-LF, Model Number: DYNJ83950B;   45) FREE FLAP A DIRTY, Model Number: DYNJ86165;   46) MAJOR SURGERY PACK, Model Number: DYNJ86816;   47) BREAST REDUCTION PACK, Model Number: DYNJ87444;   48) OMF FREE FLAP, Model Number: DYNJ902005I;   49) BREAST CDS, Model Number: DYNJ902558G;   50) TRUNCAL CONTOURING, Model Number: DYNJ903555D;   51) TRUNCAL CONTOURING, Model Number: DYNJ903555F;   52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C;   53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A;   54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A;   55) FACELIFT, Model Number: DYNJ910462;   56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283;   57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417;   58) PLASTICS PACK-LF, Model Number: PHS806973G (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-1397-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience Kits:  1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499;   2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C;   3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158;   4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170;   5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A;   6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B;   7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;   8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A;   9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B;   10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183;   11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A;   12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B;   13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A;   14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39;   15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A;   16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C;   17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46;   18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54;   19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69;   20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A;   21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B;   22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78;   23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A;   24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B;   25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84;   26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C;   27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G;   28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J;   29) BREAST PACK ASC-LF, Model Number: DYNJ36469I;   30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J;   31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F;   32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K;   33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M;   34) BREAST PACK, Model Number: DYNJ50957G;   35) PLASTICS BREAST PACK, Model Number: DYNJ55358G;   36) BHN IMPLANT PACK, Model Number: DYNJ56737A;   37) BREAST PACK, Model Number: DYNJ60210A;   38) PLASTICS PACK 2, Model Number: DYNJ64927F;   39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A;   40) BREAST IMPLANT PACK, Model Number: DYNJ69351;   41) BREAST/TUMMY PACK, Model Number: DYNJ83788;   42) HMSL PLASTICS, Model Number: DYNJ83884B;   43) CHEST/BREAST-LF, Model Number: DYNJ83950A;   44) CHEST/BREAST-LF, Model Number: DYNJ83950B;   45) FREE FLAP A DIRTY, Model Number: DYNJ86165;   46) MAJOR SURGERY PACK, Model Number: DYNJ86816;   47) BREAST REDUCTION PACK, Model Number: DYNJ87444;   48) OMF FREE FLAP, Model Number: DYNJ902005I;   49) BREAST CDS, Model Number: DYNJ902558G;   50) TRUNCAL CONTOURING, Model Number: DYNJ903555D;   51) TRUNCAL CONTOURING, Model Number: DYNJ903555F;   52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C;   53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A;   54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A;   55) FACELIFT, Model Number: DYNJ910462;   56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283;   57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417;   58) PLASTICS PACK-LF, Model Number: PHS806973G",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1397-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1397-2026: Medline Industries, LP is recalling Medline Convenience Kits:  1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499;   2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C;   3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158;   4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170;   5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A;   6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B;   7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;   8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A;   9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B;   10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183;   11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A;   12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B;   13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A;   14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39;   15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A;   16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C;   17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46;   18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54;   19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69;   20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A;   21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B;   22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78;   23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A;   24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B;   25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84;   26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C;   27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G;   28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J;   29) BREAST PACK ASC-LF, Model Number: DYNJ36469I;   30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J;   31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F;   32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K;   33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M;   34) BREAST PACK, Model Number: DYNJ50957G;   35) PLASTICS BREAST PACK, Model Number: DYNJ55358G;   36) BHN IMPLANT PACK, Model Number: DYNJ56737A;   37) BREAST PACK, Model Number: DYNJ60210A;   38) PLASTICS PACK 2, Model Number: DYNJ64927F;   39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A;   40) BREAST IMPLANT PACK, Model Number: DYNJ69351;   41) BREAST/TUMMY PACK, Model Number: DYNJ83788;   42) HMSL PLASTICS, Model Number: DYNJ83884B;   43) CHEST/BREAST-LF, Model Number: DYNJ83950A;   44) CHEST/BREAST-LF, Model Number: DYNJ83950B;   45) FREE FLAP A DIRTY, Model Number: DYNJ86165;   46) MAJOR SURGERY PACK, Model Number: DYNJ86816;   47) BREAST REDUCTION PACK, Model Number: DYNJ87444;   48) OMF FREE FLAP, Model Number: DYNJ902005I;   49) BREAST CDS, Model Number: DYNJ902558G;   50) TRUNCAL CONTOURING, Model Number: DYNJ903555D;   51) TRUNCAL CONTOURING, Model Number: DYNJ903555F;   52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C;   53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A;   54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A;   55) FACELIFT, Model Number: DYNJ910462;   56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283;   57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417;   58) PLASTICS PACK-LF, Model Number: PHS806973G",
      "text": "The FDA logged enforcement record Z-1397-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits:  1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499;   2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C;   3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158;   4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170;   5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A;   6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B;   7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;   8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A;   9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B;   10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183;   11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A;   12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B;   13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A;   14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39;   15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A;   16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C;   17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46;   18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54;   19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69;   20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A;   21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B;   22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78;   23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A;   24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B;   25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84;   26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C;   27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G;   28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J;   29) BREAST PACK ASC-LF, Model Number: DYNJ36469I;   30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J;   31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F;   32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K;   33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M;   34) BREAST PACK, Model Number: DYNJ50957G;   35) PLASTICS BREAST PACK, Model Number: DYNJ55358G;   36) BHN IMPLANT PACK, Model Number: DYNJ56737A;   37) BREAST PACK, Model Number: DYNJ60210A;   38) PLASTICS PACK 2, Model Number: DYNJ64927F;   39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A;   40) BREAST IMPLANT PACK, Model Number: DYNJ69351;   41) BREAST/TUMMY PACK, Model Number: DYNJ83788;   42) HMSL PLASTICS, Model Number: DYNJ83884B;   43) CHEST/BREAST-LF, Model Number: DYNJ83950A;   44) CHEST/BREAST-LF, Model Number: DYNJ83950B;   45) FREE FLAP A DIRTY, Model Number: DYNJ86165;   46) MAJOR SURGERY PACK, Model Number: DYNJ86816;   47) BREAST REDUCTION PACK, Model Number: DYNJ87444;   48) OMF FREE FLAP, Model Number: DYNJ902005I;   49) BREAST CDS, Model Number: DYNJ902558G;   50) TRUNCAL CONTOURING, Model Number: DYNJ903555D;   51) TRUNCAL CONTOURING, Model Number: DYNJ903555F;   52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C;   53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A;   54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A;   55) FACELIFT, Model Number: DYNJ910462;   56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283;   57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417;   58) PLASTICS PACK-LF, Model Number: PHS806973G — 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) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDB702; 2) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDA228; 3) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25ADB705; 4) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24JDA650; 5) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24IDA403; 6) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23LDC086; 7) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23IDB182; 8) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23HDB786; 9) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21JDB530; 10) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21HDB434; 11) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21GDB740; 12) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21FDA888; 13) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21DDA661; 14) DYKMBNDL117C, UDI-DI: 10195327371104(each), 40195327371105(case), Lot Number: 23DLA834; 15) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21CBE548; 16) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21ABI978; 17) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22IBC515; 18) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22HBN456; 19) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22EBA143; 20) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21IBV640; 21) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21DBN049; 22) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21BBH637; 23) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21ABJ202; 24) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 20LBY951; 25) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23IBB851; 26) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBG507; 27) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBB877; 28) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23GBR888; 29) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 22JBM366; 30) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25LBM160; 31) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25KBR870; 32) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25GBA895; 33) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25EBM448; 34) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBS731; 35) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBK034; 36) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBN216; 37) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBA340; 38) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24IBB931; 39) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBL546; 40) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBD539; 41) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 23LBI220; 42) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22FBC879; 43) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22EBO665; 44) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22BBN306; 45) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21DBC569; 46) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABX025; 47) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABI990; 48) DYKMBNDL182A, UDI-DI: 10195327633806(each), 40195327633807(case), Lot Number: 24BBN507; 49) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25FBO935; 50) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25ABL533; 51) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24KBS891; 52) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBQ469; 53) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBL678; 54) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24DBR913; 55) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21JBJ252; 56) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21CBG305; 57) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21ABI992; 58) DYKMBNDL183A, UDI-DI: 10195327246594(each), 40195327246595(case), Lot Number: 23BBI487; 59) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24GBC829; 60) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24DBT970; 61) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24DBJ591; 62) DYKMBNDL34A, UDI-DI: 10193489872033(each), 40193489872034(case), Lot Number: 21DBQ512; 63) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22IBC434; 64) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22GBM861; 65) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22BBU074; 66) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21LBJ742; 67) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21GBR352; 68) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21CBD335; 69) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21ABJ002; 70) DYKMBNDL39A, UDI-DI: 10195327241308(each), 40195327241309(case), Lot Number: 23ABH677; 71) DYKMBNDL39C, UDI-DI: 10198459112461(each), 40198459112462(case), Lot Number: 25GBW751; 72) DYKMBNDL39C, UDI-DI: 10198459112461(each), 40198459112462(case), Lot Number: 24JBO020; 73) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21GBR353; 74) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21BBM839; 75) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21ABL308; 76) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21CBG791; 77) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21BBH629; 78) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABO607; 79) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABM089; 80) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABJ589; 81) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 20LBY967; 82) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22JBC409; 83) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22IBR235; 84) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22HBQ100; 85) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22HBN457; 86) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21JBS176; 87) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21IBV702; 88) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBO272; 89) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBM983; 90) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBK340; 91) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21GBR324; 92) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21DBC571; 93) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21ABL345; 94) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21ABJ013; 95) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23LBA275; 96) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23JBJ695; 97) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23GBL960; 98) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23FBP246; 99) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22KBO876; 100) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBQ852; 101) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBJ150; 102) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBC626; 103) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBC618; 104) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25KBP763; 105) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25GBL984; 106) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25FBH462; 107) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24KBT018; 108) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24HBM099; 109) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24GBF481; 110) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24EBR715; 111) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22EBS816; 112) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22CBX537; 113) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22BBL848; 114) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22ABL251; 115) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22ABG018; 116) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21LBY278; 117) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21LBO572; 118) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21KBY757; 119) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21JBJ751; 120) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21IBV643; 121) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21IBB097; 122) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21HBK310; 123) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21FBR398; 124) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21FBF907; 125) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21DBC549; 126) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21BBK531; 127) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21ABX017; 128) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21ABJ216; 129) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 20XBB257; 130) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23LBE774; 131) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23JBN862; 132) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23GBP831; 133) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23GBO451; 134) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22KBO921; 135) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBQ856; 136) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBJ143; 137) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBJ019; 138) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25FBP527; 139) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25EBM007; 140) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25EBE325; 141) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25CBG915; 142) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBU089; 143) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBO685; 144) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBE752; 145) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24LBL035; 146) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24HBD157; 147) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24EBU597; 148) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24EBE953; 149) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24CBR114; 150) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24CBF892; 151) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22OBH455; 152) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22IBC435; 153) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22HBO907; 154) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22FBT013; 155) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22FBF307; 156) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21LBH705; 157) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21LBD628; 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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-1397-2026&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-1397-2026&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-1397-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1397-2026 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",
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        "adjudged": true,
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      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1397-2026&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-1397-2026&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-1397-2026/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",
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
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            "Field": "Recall number",
            "Value": "Z-1397-2026",
            "Status": "recorded"
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        },
        {
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          "item": {
            "Field": "Product type",
            "Value": "Devices",
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        },
        {
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          "position": 3,
          "item": {
            "Field": "Classification",
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            "Status": "determination"
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        },
        {
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          "item": {
            "Field": "Status",
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            "Status": "recorded"
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        },
        {
          "@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",
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            "Value": "1) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDB702; 2) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDA228; 3) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25ADB705; 4) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24JDA650; 5) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24IDA403; 6) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23LDC086; 7) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23IDB182; 8) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23HDB786; 9) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21JDB530; 10) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21HDB434; 11) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21GDB740; 12) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21FDA888; 13) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21DDA661; 14) DYKMBNDL117C, UDI-DI: 10195327371104(each), 40195327371105(case), Lot Number: 23DLA834; 15) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21CBE548; 16) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21ABI978; 17) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22IBC515; 18) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22HBN456; 19) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22EBA143; 20) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21IBV640; 21) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21DBN049; 22) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21BBH637; 23) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21ABJ202; 24) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 20LBY951; 25) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23IBB851; 26) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBG507; 27) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBB877; 28) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23GBR888; 29) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 22JBM366; 30) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25LBM160; 31) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25KBR870; 32) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25GBA895; 33) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25EBM448; 34) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBS731; 35) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBK034; 36) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBN216; 37) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBA340; 38) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24IBB931; 39) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBL546; 40) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBD539; 41) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 23LBI220; 42) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22FBC879; 43) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22EBO665; 44) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22BBN306; 45) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21DBC569; 46) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABX025; 47) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABI990; 48) DYKMBNDL182A, UDI-DI: 10195327633806(each), 40195327633807(case), Lot Number: 24BBN507; 49) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25FBO935; 50) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25ABL533; 51) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24KBS891; 52) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBQ469; 53) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBL678; 54) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24DBR913; 55) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21JBJ252; 56) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21CBG305; 57) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21ABI992; 58) DYKMBNDL183A, UDI-DI: 10195327246594(each), 40195327246595(case), Lot Number: 23BBI487; 59) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24GBC829; 60) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24DBT970; 61) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24DBJ591; 62) DYKMBNDL34A, UDI-DI: 10193489872033(each), 40193489872034(case), Lot Number: 21DBQ512; 63) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22IBC434; 64) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22GBM861; 65) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22BBU074; 66) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21LBJ742; 67) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21GBR352; 68) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21CBD335; 69) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21ABJ002; 70) DYKMBNDL39A, UDI-DI: 10195327241308(each), 40195327241309(case), Lot Number: 23ABH677; 71) DYKMBNDL39C, UDI-DI: 10198459112461(each), 40198459112462(case), Lot Number: 25GBW751; 72) DYKMBNDL39C, UDI-DI: 10198459112461(each), 40198459112462(case), Lot Number: 24JBO020; 73) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21GBR353; 74) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21BBM839; 75) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21ABL308; 76) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21CBG791; 77) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21BBH629; 78) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABO607; 79) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABM089; 80) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABJ589; 81) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 20LBY967; 82) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22JBC409; 83) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22IBR235; 84) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22HBQ100; 85) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22HBN457; 86) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21JBS176; 87) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21IBV702; 88) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBO272; 89) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBM983; 90) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBK340; 91) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21GBR324; 92) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21DBC571; 93) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21ABL345; 94) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21ABJ013; 95) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23LBA275; 96) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23JBJ695; 97) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23GBL960; 98) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23FBP246; 99) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22KBO876; 100) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBQ852; 101) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBJ150; 102) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBC626; 103) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBC618; 104) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25KBP763; 105) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25GBL984; 106) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25FBH462; 107) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24KBT018; 108) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24HBM099; 109) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24GBF481; 110) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24EBR715; 111) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22EBS816; 112) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22CBX537; 113) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22BBL848; 114) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22ABL251; 115) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22ABG018; 116) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21LBY278; 117) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21LBO572; 118) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21KBY757; 119) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21JBJ751; 120) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21IBV643; 121) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21IBB097; 122) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21HBK310; 123) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21FBR398; 124) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21FBF907; 125) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21DBC549; 126) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21BBK531; 127) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21ABX017; 128) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21ABJ216; 129) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 20XBB257; 130) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23LBE774; 131) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23JBN862; 132) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23GBP831; 133) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23GBO451; 134) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22KBO921; 135) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBQ856; 136) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBJ143; 137) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBJ019; 138) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25FBP527; 139) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25EBM007; 140) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25EBE325; 141) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25CBG915; 142) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBU089; 143) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBO685; 144) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBE752; 145) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24LBL035; 146) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24HBD157; 147) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24EBU597; 148) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24EBE953; 149) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24CBR114; 150) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24CBF892; 151) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22OBH455; 152) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22IBC435; 153) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22HBO907; 154) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22FBT013; 155) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22FBF307; 156) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21LBH705; 157) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21LBD628; 158) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21JBH111; 159) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21IBT011; 160) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21GBR338; 161) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21GBF538; 162) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21EBH614; 163) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21CBM835; 164) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21ABU822; 165) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21ABM088; 166) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25LBQ326; 167) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25LBP864; 168) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25HBG553; 169) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25GBF486; 170) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25FBB154; 171) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25DBO560; 172) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24LBS883; 173) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24LBI135; 174) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24JBE336; 175) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24IBE175; 176) DYNJ0785310G, UDI-DI: 10193489268966(each), 40193489268967(case), Lot Number: 23KMH075; 177) DYNJ0854650J, UDI-DI: 10193489832426(each), 40193489832427(case), Lot Number: 24IMF274; 178) DYNJ36469I, UDI-DI: 10195327513931(each), 40195327513932(case), Lot Number: 24BBU341; 179) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21CDB475; 180) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21BDB779; 181) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21ADA533; 182) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24KMD041; 183) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24IME867; 184) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24GMA471; 185) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24DMJ046; 186) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24CMD088; 187) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24AMI035; 188) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23LMB124; 189) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23KMA468; 190) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23IMG016; 191) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23HMA900; 192) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23AME665; 193) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22IMF713; 194) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22HMH034; 195) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22GMF684; 196) DYNJ44852K, UDI-DI: 10195327127589(each), 40195327127580(case), Lot Number: 22CMI118; 197) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 25EME929; 198) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 25CME690; 199) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24KME600; 200) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24GMI186; 201) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24CMC758; 202) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24AMB315; 203) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23HME689; 204) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23FMH424; 205) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23DMD096; 206) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23CMF343; 207) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23AMC530; 208) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23AMC374; 209) DYNJ50957G, UDI-DI: 10193489448863(each), 40193489448864(case), Lot Number: 23GBV065; 210) DYNJ55358G, UDI-DI: 10195327173500(each), 40195327173501(case), Lot Number: 23FBN323; 211) DYNJ56737A, UDI-DI: 10193489395594(each), 40193489395595(case), Lot Number: 23CME388; 212) DYNJ60210A, UDI-DI: 10193489985108(each), 40193489985109(case), Lot Number: 21KBP457; 213) DYNJ64927F, UDI-DI: 10195327143091(each), 40195327143092(case), Lot Number: 23FBV335; 214) DYNJ68844A, UDI-DI: 10195327216504(each), 40195327216505(case), Lot Number: 23HMB858; 215) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 24BBL537; 216) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23KBN973; 217) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23JBU455; 218) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23HBY228; 219) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23CBG820; 220) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23BBP453; 221) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23BBD661; 222) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 21LBP376; 223) DYNJ83788, UDI-DI: 10195327305833(each), 40195327305834(case), Lot Number: 23CBO212; 224) DYNJ83884B, UDI-DI: 10198459234620(each), 40198459234621(case), Lot Number: 25GBO120; 225) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 25ABF915; 226) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24JBV233; 227) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24FBL440; 228) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24EBR736; 229) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25DBT195; 230) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25CBF253; 231) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25ABT952; 232) DYNJ86165, UDI-DI: 10195327599324(each), 40195327599325(case), Lot Number: 25ABJ747; 233) DYNJ86816, UDI-DI: 10195327679903(each), 40195327679904(case), Lot Number: 24FMB609; 234) DYNJ87444, UDI-DI: 10198459040122(each), 40198459040123(case), Lot Number: 24GBQ988; 235) DYNJ902005I, UDI-DI: 10195327347710(each), 40195327347711(case), Lot Number: 24DLA844; 236) DYNJ902558G, UDI-DI: 10193489728859(each), 40193489728850(case), Lot Number: 23HMG989; 237) DYNJ903555D, UDI-DI: 10195327084615(each), 40195327084616(case), Lot Number: 22HBF672; 238) DYNJ903555D, UDI-DI: 10195327084615(each), 40195327084616(case), Lot Number: 22GBT713; 239) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBP519; 240) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBP518; 241) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBG876; 242) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23FBN475; 243) DYNJ903849C, UDI-DI: 10195327333355(each), 40195327333356(case), Lot Number: 23DBS608; 244) DYNJ907847A, UDI-DI: 10193489937589(each), 40193489937580(case), Lot Number: 23IMF989; 245) DYNJ907874A, UDI-DI: 10195327241247(each), 40195327241248(case), Lot Number: 23FLA249; 246) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24JMD608; 247) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24IMF741; 248) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24GME383; 249) DYNJT3283, UDI-DI: 10198459323645(each), 40198459323646(case), Lot Number: 25JBI499; 250) DYNJT3417, UDI-DI: 10198459324888(each), 40198459324889(case), Lot Number: 25EBN203; 251) PHS806973G, UDI-DI: 10193489926996(each), 40193489926997(case), Lot Number: 23EBQ702",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}