{
  "@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-1086-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical procedure convenience kits labeled as:    1) LAPAROSCOPY CDS-LF, REF CDS860235L;   2) GENERAL LAPAROSCOPIC, REF CDS930223M;   3) LAP CHOLE CDS, REF CDS983678K;   4) LAPAROSCOPY PELV CDS, REF CDS983679K;   5) LAP CHOLE CDS-LF, REF CDS983752M;   6) LAP CHOLE CDS-LF, REF CDS984016B;   7) LAP CHOLE KIT, REF CDS984020P;   8) LAP CHOLE-LF, REF CDS984175J;   9) LAP COLON CDS, REF CDS984849N;   10) GENERAL LAPAROSCOPY CDS, REF CDS985328M;   11) LAP CHOLE, REF DYNJQ9044O;   12) GENERAL LAPAROSCOPY V, REF DYNJS2032F;   13) LAP CHOLE PACK, REF DYNJ26209R;   14) LAP CHOLE PACK, REF DYNJ26209S;   15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D;   16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G;   17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G;   18) LAP CHOLE PACK, REF DYNJ51785D;   19) LAPAROSCOPY PACK, REF DYNJ61652A;   20) ENDOSCOPY, REF DYNJ62133A;   21) LAP CHOLE PACK, REF DYNJ66285A;   22) LAPAROSCOPY PACK, REF DYNJ66289B;   23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D;   24) LAPAROSCOPY PACK, REF DYNJ68187A;   25) LAP OB PACK, REF DYNJ68741A;   26) LAP CHOLE PACK-LF, REF DYNJ81408A;   27) LAP CHOLE PACK-LF, REF DYNJ81408B;   28) LAP CHOLE PACK, REF DYNJ85318;   29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677;   30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J;   31) LAP CHOLE, REF DYNJ901126G;   32) BARIATRIC KIT, REF DYNJ901145I;   33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M;   34) LAP GASTRIC SLEEVE, REF DYNJ901504L;   35) GENERAL LAP GASTRIC, REF DYNJ901827X;   36) GENERAL LAPAROSCOPY, REF DYNJ901847N;   37) LOU LAP SIGMOID COLON, REF DYNJ901848L;   38) LAP CHOLE, REF DYNJ901870J;   39) LEX BARIATRIC, REF DYNJ902033L;   40) BARIATRIC, REF DYNJ902515K;   41) LAP CHOLE CDS, REF DYNJ902565K;   42) LAP CHOLE, REF DYNJ902995I;   43) LAP CHOLE, REF DYNJ903163L;   44) LAP APPY, REF DYNJ903164L;   45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C;   46) LAP CHOLE, REF DYNJ904693D;   47) BARIATRIC, REF DYNJ904891N;   48) LAPAROSCOPY, REF DYNJ905071F;   49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F;   50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G;   51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D;   52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A;   53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B;   54) LAP BARIATRIC, REF DYNJ905733K;   55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A;   56) LAP CHOLE, REF DYNJ906277D;   57) LAP CHOLE RFD, REF DYNJ906302D;   58) KIT LAP COLON RFD, REF DYNJ906315D;   59) GASTRIC SLEEVE, REF DYNJ906355D;   60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C;   61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C;   62) GEN BARIATRIC, REF DYNJ907639D;   63) LAP CHOLE, REF DYNJ908415B;   64) LAP CHOLE, REF DYNJ908415C;   65) LAPAROSCOPIC, REF DYNJ908569B;   66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G;   67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A;   68) BARIATRIC CENTRASTATE, REF DYNJ909817A;   69) LAP GENERAL THEDA, REF DYNJ910050;   70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A;   71) ROBOTIC THORACIC, REF DYNJ910386;   72) BARIATRIC, REF DYNJ911017.",
  "description": "FDA recall Z-1086-2026 — Medline Industries, LP is recalling Medline medical procedure convenience kits labeled as:    1) LAPAROSCOPY CDS-LF, REF CDS860235L;   2) GENERAL LAPAROSCOPIC, REF CDS930223M;   3) LAP CHOLE CDS, REF CDS983678K;   4) LAPAROSCOPY PELV CDS, REF CDS983679K;   5) LAP CHOLE CDS-LF, REF CDS983752M;   6) LAP CHOLE CDS-LF, REF CDS984016B;   7) LAP CHOLE KIT, REF CDS984020P;   8) LAP CHOLE-LF, REF CDS984175J;   9) LAP COLON CDS, REF CDS984849N;   10) GENERAL LAPAROSCOPY CDS, REF CDS985328M;   11) LAP CHOLE, REF DYNJQ9044O;   12) GENERAL LAPAROSCOPY V, REF DYNJS2032F;   13) LAP CHOLE PACK, REF DYNJ26209R;   14) LAP CHOLE PACK, REF DYNJ26209S;   15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D;   16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G;   17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G;   18) LAP CHOLE PACK, REF DYNJ51785D;   19) LAPAROSCOPY PACK, REF DYNJ61652A;   20) ENDOSCOPY, REF DYNJ62133A;   21) LAP CHOLE PACK, REF DYNJ66285A;   22) LAPAROSCOPY PACK, REF DYNJ66289B;   23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D;   24) LAPAROSCOPY PACK, REF DYNJ68187A;   25) LAP OB PACK, REF DYNJ68741A;   26) LAP CHOLE PACK-LF, REF DYNJ81408A;   27) LAP CHOLE PACK-LF, REF DYNJ81408B;   28) LAP CHOLE PACK, REF DYNJ85318;   29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677;   30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J;   31) LAP CHOLE, REF DYNJ901126G;   32) BARIATRIC KIT, REF DYNJ901145I;   33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M;   34) LAP GASTRIC SLEEVE, REF DYNJ901504L;   35) GENERAL LAP GASTRIC, REF DYNJ901827X;   36) GENERAL LAPAROSCOPY, REF DYNJ901847N;   37) LOU LAP SIGMOID COLON, REF DYNJ901848L;   38) LAP CHOLE, REF DYNJ901870J;   39) LEX BARIATRIC, REF DYNJ902033L;   40) BARIATRIC, REF DYNJ902515K;   41) LAP CHOLE CDS, REF DYNJ902565K;   42) LAP CHOLE, REF DYNJ902995I;   43) LAP CHOLE, REF DYNJ903163L;   44) LAP APPY, REF DYNJ903164L;   45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C;   46) LAP CHOLE, REF DYNJ904693D;   47) BARIATRIC, REF DYNJ904891N;   48) LAPAROSCOPY, REF DYNJ905071F;   49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F;   50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G;   51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D;   52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A;   53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B;   54) LAP BARIATRIC, REF DYNJ905733K;   55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A;   56) LAP CHOLE, REF DYNJ906277D;   57) LAP CHOLE RFD, REF DYNJ906302D;   58) KIT LAP COLON RFD, REF DYNJ906315D;   59) GASTRIC SLEEVE, REF DYNJ906355D;   60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C;   61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C;   62) GEN BARIATRIC, REF DYNJ907639D;   63) LAP CHOLE, REF DYNJ908415B;   64) LAP CHOLE, REF DYNJ908415C;   65) LAPAROSCOPIC, REF DYNJ908569B;   66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G;   67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A;   68) BARIATRIC CENTRASTATE, REF DYNJ909817A;   69) LAP GENERAL THEDA, REF DYNJ910050;   70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A;   71) ROBOTIC THORACIC, REF DYNJ910386;   72) BARIATRIC, REF DYNJ911017. (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-1086-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical procedure convenience kits labeled as:    1) LAPAROSCOPY CDS-LF, REF CDS860235L;   2) GENERAL LAPAROSCOPIC, REF CDS930223M;   3) LAP CHOLE CDS, REF CDS983678K;   4) LAPAROSCOPY PELV CDS, REF CDS983679K;   5) LAP CHOLE CDS-LF, REF CDS983752M;   6) LAP CHOLE CDS-LF, REF CDS984016B;   7) LAP CHOLE KIT, REF CDS984020P;   8) LAP CHOLE-LF, REF CDS984175J;   9) LAP COLON CDS, REF CDS984849N;   10) GENERAL LAPAROSCOPY CDS, REF CDS985328M;   11) LAP CHOLE, REF DYNJQ9044O;   12) GENERAL LAPAROSCOPY V, REF DYNJS2032F;   13) LAP CHOLE PACK, REF DYNJ26209R;   14) LAP CHOLE PACK, REF DYNJ26209S;   15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D;   16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G;   17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G;   18) LAP CHOLE PACK, REF DYNJ51785D;   19) LAPAROSCOPY PACK, REF DYNJ61652A;   20) ENDOSCOPY, REF DYNJ62133A;   21) LAP CHOLE PACK, REF DYNJ66285A;   22) LAPAROSCOPY PACK, REF DYNJ66289B;   23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D;   24) LAPAROSCOPY PACK, REF DYNJ68187A;   25) LAP OB PACK, REF DYNJ68741A;   26) LAP CHOLE PACK-LF, REF DYNJ81408A;   27) LAP CHOLE PACK-LF, REF DYNJ81408B;   28) LAP CHOLE PACK, REF DYNJ85318;   29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677;   30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J;   31) LAP CHOLE, REF DYNJ901126G;   32) BARIATRIC KIT, REF DYNJ901145I;   33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M;   34) LAP GASTRIC SLEEVE, REF DYNJ901504L;   35) GENERAL LAP GASTRIC, REF DYNJ901827X;   36) GENERAL LAPAROSCOPY, REF DYNJ901847N;   37) LOU LAP SIGMOID COLON, REF DYNJ901848L;   38) LAP CHOLE, REF DYNJ901870J;   39) LEX BARIATRIC, REF DYNJ902033L;   40) BARIATRIC, REF DYNJ902515K;   41) LAP CHOLE CDS, REF DYNJ902565K;   42) LAP CHOLE, REF DYNJ902995I;   43) LAP CHOLE, REF DYNJ903163L;   44) LAP APPY, REF DYNJ903164L;   45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C;   46) LAP CHOLE, REF DYNJ904693D;   47) BARIATRIC, REF DYNJ904891N;   48) LAPAROSCOPY, REF DYNJ905071F;   49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F;   50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G;   51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D;   52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A;   53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B;   54) LAP BARIATRIC, REF DYNJ905733K;   55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A;   56) LAP CHOLE, REF DYNJ906277D;   57) LAP CHOLE RFD, REF DYNJ906302D;   58) KIT LAP COLON RFD, REF DYNJ906315D;   59) GASTRIC SLEEVE, REF DYNJ906355D;   60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C;   61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C;   62) GEN BARIATRIC, REF DYNJ907639D;   63) LAP CHOLE, REF DYNJ908415B;   64) LAP CHOLE, REF DYNJ908415C;   65) LAPAROSCOPIC, REF DYNJ908569B;   66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G;   67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A;   68) BARIATRIC CENTRASTATE, REF DYNJ909817A;   69) LAP GENERAL THEDA, REF DYNJ910050;   70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A;   71) ROBOTIC THORACIC, REF DYNJ910386;   72) BARIATRIC, REF DYNJ911017.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1086-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1086-2026: Medline Industries, LP is recalling Medline medical procedure convenience kits labeled as:    1) LAPAROSCOPY CDS-LF, REF CDS860235L;   2) GENERAL LAPAROSCOPIC, REF CDS930223M;   3) LAP CHOLE CDS, REF CDS983678K;   4) LAPAROSCOPY PELV CDS, REF CDS983679K;   5) LAP CHOLE CDS-LF, REF CDS983752M;   6) LAP CHOLE CDS-LF, REF CDS984016B;   7) LAP CHOLE KIT, REF CDS984020P;   8) LAP CHOLE-LF, REF CDS984175J;   9) LAP COLON CDS, REF CDS984849N;   10) GENERAL LAPAROSCOPY CDS, REF CDS985328M;   11) LAP CHOLE, REF DYNJQ9044O;   12) GENERAL LAPAROSCOPY V, REF DYNJS2032F;   13) LAP CHOLE PACK, REF DYNJ26209R;   14) LAP CHOLE PACK, REF DYNJ26209S;   15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D;   16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G;   17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G;   18) LAP CHOLE PACK, REF DYNJ51785D;   19) LAPAROSCOPY PACK, REF DYNJ61652A;   20) ENDOSCOPY, REF DYNJ62133A;   21) LAP CHOLE PACK, REF DYNJ66285A;   22) LAPAROSCOPY PACK, REF DYNJ66289B;   23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D;   24) LAPAROSCOPY PACK, REF DYNJ68187A;   25) LAP OB PACK, REF DYNJ68741A;   26) LAP CHOLE PACK-LF, REF DYNJ81408A;   27) LAP CHOLE PACK-LF, REF DYNJ81408B;   28) LAP CHOLE PACK, REF DYNJ85318;   29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677;   30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J;   31) LAP CHOLE, REF DYNJ901126G;   32) BARIATRIC KIT, REF DYNJ901145I;   33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M;   34) LAP GASTRIC SLEEVE, REF DYNJ901504L;   35) GENERAL LAP GASTRIC, REF DYNJ901827X;   36) GENERAL LAPAROSCOPY, REF DYNJ901847N;   37) LOU LAP SIGMOID COLON, REF DYNJ901848L;   38) LAP CHOLE, REF DYNJ901870J;   39) LEX BARIATRIC, REF DYNJ902033L;   40) BARIATRIC, REF DYNJ902515K;   41) LAP CHOLE CDS, REF DYNJ902565K;   42) LAP CHOLE, REF DYNJ902995I;   43) LAP CHOLE, REF DYNJ903163L;   44) LAP APPY, REF DYNJ903164L;   45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C;   46) LAP CHOLE, REF DYNJ904693D;   47) BARIATRIC, REF DYNJ904891N;   48) LAPAROSCOPY, REF DYNJ905071F;   49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F;   50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G;   51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D;   52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A;   53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B;   54) LAP BARIATRIC, REF DYNJ905733K;   55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A;   56) LAP CHOLE, REF DYNJ906277D;   57) LAP CHOLE RFD, REF DYNJ906302D;   58) KIT LAP COLON RFD, REF DYNJ906315D;   59) GASTRIC SLEEVE, REF DYNJ906355D;   60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C;   61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C;   62) GEN BARIATRIC, REF DYNJ907639D;   63) LAP CHOLE, REF DYNJ908415B;   64) LAP CHOLE, REF DYNJ908415C;   65) LAPAROSCOPIC, REF DYNJ908569B;   66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G;   67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A;   68) BARIATRIC CENTRASTATE, REF DYNJ909817A;   69) LAP GENERAL THEDA, REF DYNJ910050;   70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A;   71) ROBOTIC THORACIC, REF DYNJ910386;   72) BARIATRIC, REF DYNJ911017.",
      "text": "The FDA logged enforcement record Z-1086-2026: Medline Industries, LP is voluntarily recalling Medline medical procedure convenience kits labeled as:    1) LAPAROSCOPY CDS-LF, REF CDS860235L;   2) GENERAL LAPAROSCOPIC, REF CDS930223M;   3) LAP CHOLE CDS, REF CDS983678K;   4) LAPAROSCOPY PELV CDS, REF CDS983679K;   5) LAP CHOLE CDS-LF, REF CDS983752M;   6) LAP CHOLE CDS-LF, REF CDS984016B;   7) LAP CHOLE KIT, REF CDS984020P;   8) LAP CHOLE-LF, REF CDS984175J;   9) LAP COLON CDS, REF CDS984849N;   10) GENERAL LAPAROSCOPY CDS, REF CDS985328M;   11) LAP CHOLE, REF DYNJQ9044O;   12) GENERAL LAPAROSCOPY V, REF DYNJS2032F;   13) LAP CHOLE PACK, REF DYNJ26209R;   14) LAP CHOLE PACK, REF DYNJ26209S;   15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D;   16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G;   17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G;   18) LAP CHOLE PACK, REF DYNJ51785D;   19) LAPAROSCOPY PACK, REF DYNJ61652A;   20) ENDOSCOPY, REF DYNJ62133A;   21) LAP CHOLE PACK, REF DYNJ66285A;   22) LAPAROSCOPY PACK, REF DYNJ66289B;   23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D;   24) LAPAROSCOPY PACK, REF DYNJ68187A;   25) LAP OB PACK, REF DYNJ68741A;   26) LAP CHOLE PACK-LF, REF DYNJ81408A;   27) LAP CHOLE PACK-LF, REF DYNJ81408B;   28) LAP CHOLE PACK, REF DYNJ85318;   29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677;   30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J;   31) LAP CHOLE, REF DYNJ901126G;   32) BARIATRIC KIT, REF DYNJ901145I;   33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M;   34) LAP GASTRIC SLEEVE, REF DYNJ901504L;   35) GENERAL LAP GASTRIC, REF DYNJ901827X;   36) GENERAL LAPAROSCOPY, REF DYNJ901847N;   37) LOU LAP SIGMOID COLON, REF DYNJ901848L;   38) LAP CHOLE, REF DYNJ901870J;   39) LEX BARIATRIC, REF DYNJ902033L;   40) BARIATRIC, REF DYNJ902515K;   41) LAP CHOLE CDS, REF DYNJ902565K;   42) LAP CHOLE, REF DYNJ902995I;   43) LAP CHOLE, REF DYNJ903163L;   44) LAP APPY, REF DYNJ903164L;   45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C;   46) LAP CHOLE, REF DYNJ904693D;   47) BARIATRIC, REF DYNJ904891N;   48) LAPAROSCOPY, REF DYNJ905071F;   49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F;   50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G;   51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D;   52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A;   53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B;   54) LAP BARIATRIC, REF DYNJ905733K;   55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A;   56) LAP CHOLE, REF DYNJ906277D;   57) LAP CHOLE RFD, REF DYNJ906302D;   58) KIT LAP COLON RFD, REF DYNJ906315D;   59) GASTRIC SLEEVE, REF DYNJ906355D;   60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C;   61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C;   62) GEN BARIATRIC, REF DYNJ907639D;   63) LAP CHOLE, REF DYNJ908415B;   64) LAP CHOLE, REF DYNJ908415C;   65) LAPAROSCOPIC, REF DYNJ908569B;   66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G;   67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A;   68) BARIATRIC CENTRASTATE, REF DYNJ909817A;   69) LAP GENERAL THEDA, REF DYNJ910050;   70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A;   71) ROBOTIC THORACIC, REF DYNJ910386;   72) BARIATRIC, REF DYNJ911017. — reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-16. Affected lots/codes: REF CDS860235L:  UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMH913;  REF CDS860235L:  UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMC376;  REF CDS860235L:  UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CMJ688;  REF CDS860235L:  UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CME476;  REF CDS930223M:  UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25EBM987;  REF CDS930223M:  UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25CBT666;  REF CDS983678K:  UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25FBP815;  REF CDS983678K:  UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25EBN002;  REF CDS983678K:  UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25CBN212;  REF CDS983679K:  UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25FBN760;  REF CDS983679K:  UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25EBD329;  REF CDS983679K:  UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBN040;  REF CDS983679K:  UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBK313;  REF CDS983679K:  UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25CBE452;  REF CDS983752M:  UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMH793;  REF CDS983752M:  UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMC405;  REF CDS984016B:  UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25EBN676;  REF CDS984016B:  UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25DBO816;  REF CDS984016B:  UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25CBJ724;  REF CDS984016B:  UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25BBK265;  REF CDS984020P:  UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25EMG591;  REF CDS984020P:  UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25DMH851;  REF CDS984020P:  UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25CMH945;  REF CDS984175J:  UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBS490;  REF CDS984175J:  UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBI971;  REF CDS984175J:  UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25DBO242;  REF CDS984175J:  UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25CBO208;  REF CDS984849N:  UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA838;  REF CDS984849N:  UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA425;  REF CDS985328M:  UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25CBP120;  REF CDS985328M:  UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25BBN336;  REF DYNJQ9044O:  UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25FBG772;  REF DYNJQ9044O:  UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25EBG794;  REF DYNJQ9044O:  UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25DBF556;  REF DYNJQ9044O:  UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25CBQ563;  REF DYNJS2032F:  UDI/DI 10198459023774 (EA)40198459023775 (CS), Kit Lot Number 25EDC051;  REF DYNJ26209R:  UDI/DI 10198459265167 (EA)40198459265168 (CS), Kit Lot Number 25BMG526;  REF DYNJ26209S:  UDI/DI 10198459352614 (EA)40198459352615 (CS), Kit Lot Number 25FMA594;  REF DYNJ37459D:  UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25EBD946;  REF DYNJ37459D:  UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25CBS951;  REF DYNJ42578G:  UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25EBH485;  REF DYNJ42578G:  UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25DBK606;  REF DYNJ42578G:  UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25CBN430;  REF DYNJ45083G:  UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25FBK260;  REF DYNJ45083G:  UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25EBH397;  REF DYNJ45083G:  UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25DBT090;  REF DYNJ51785D:  UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25FDA326;  REF DYNJ51785D:  UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25CDA693;  REF DYNJ61652A:  UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25EMF946;  REF DYNJ61652A:  UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25CMG793;  REF DYNJ62133A:  UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25FBI408;  REF DYNJ62133A:  UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25CBR811;  REF DYNJ62133A:  UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25BBR383;  REF DYNJ66285A:  UDI/DI 10193489428070 (EA)40193489428071 (CS), Kit Lot Number 25DBG032;  REF DYNJ66289B:  UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit Lot Number 25EBA558;  REF DYNJ66289B:  UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit Lot Number 25DBC195;  REF DYNJ67296D:  UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25FBM369;  REF DYNJ67296D:  UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25DBF833;  REF DYNJ67296D:  UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25DBC575;  REF DYNJ67296D:  UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25CBI966;  REF DYNJ68187A:  UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit Lot Number 25FMB779;  REF DYNJ68187A:  UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit Lot Number 25DMD529;  REF DYNJ68741A:  UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit Lot Number 25DMH940;  REF DYNJ68741A:  UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit Lot Number 25BMH074;  REF DYNJ81408A:  UDI/DI 10198459133947 (EA)40198459133948 (CS), Kit Lot Number 25CMB055;  REF DYNJ81408B:  UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25FMC540;  REF DYNJ81408B:  UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25CMG686;  REF DYNJ81408B:  UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25CMD691;  REF DYNJ85318:  UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit Lot Number 25EBL562;  REF DYNJ85318:  UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit Lot Number 25CBP974;  REF DYNJ89677:  UDI/DI 10198459281716 (EA)40198459281717 (CS), Kit Lot Number 25CMF548;  REF DYNJ900969J:  UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit Lot Number 25DBP346;  REF DYNJ900969J:  UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit Lot Number 25CBH795;  REF DYNJ901126G:  UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit Lot Number 25FBE871;  REF DYNJ901126G:  UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit Lot Number 25EBG615;  REF DYNJ901145I:  UDI/DI 10195327603960 (EA)40195327603961 (CS), Kit Lot Number 25EBH921;  REF DYNJ901164M:  UDI/DI 10195327468675 (EA)40195327468676 (CS), Kit Lot Number 25DBR923;  REF DYNJ901504L:  UDI/DI 10195327524456 (EA)40195327524457 (CS), Kit Lot Number 25CBH718;  REF DYNJ901827X:  UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25FDA155;  REF DYNJ901827X:  UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25EDA571;  REF DYNJ901827X:  UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25CDA197;  REF DYNJ901847N:  UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25FBG897;  REF DYNJ901847N:  UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25EBJ874;  REF DYNJ901847N:  UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25DBM222;  REF DYNJ901848L:  UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit Lot Number 25FBH903;  REF DYNJ901848L:  UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit Lot Number 25EBH888;  REF DYNJ901870J:  UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit Lot Number 25EBV494;  REF DYNJ901870J:  UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit Lot Number 25DBD971;  REF DYNJ902033L:  UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit Lot Number 25EBQ971;  REF DYNJ902033L:  UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit Lot Number 25CBR575;  REF DYNJ902515K:  UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit Lot Number 25EBH883;  REF DYNJ902515K:  UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit Lot Number 25DBC358;  REF DYNJ902565K:  UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit Lot Number 25EMD967;  REF DYNJ902565K:  UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit Lot Number 25DMG347;  REF DYNJ902995I:  UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit Lot Number 25EMH930;  REF DYNJ902995I:  UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit Lot Number 25DMB723;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25EME835;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25DMJ465;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25DMF401;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25BMJ071;  REF DYNJ903164L:  UDI/DI 10198459222740 (EA)40198459222741 (CS), Kit Lot Number 25FMD784;  REF DYNJ903733C:  UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit Lot Number 25FBC756;  REF DYNJ903733C:  UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit Lot Number 25EBF091;  REF DYNJ904693D:  UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25HBJ124;  REF DYNJ904693D:  UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25FBF713;  REF DYNJ904693D:  UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25DBJ916;  REF DYNJ904891N:  UDI/DI 10198459071881 (EA)40198459071882 (CS), Kit Lot Number 25DBM300;  REF DYNJ905071F:  UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25EBO479;  REF DYNJ905071F:  UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25DBF405;  REF DYNJ905071F:  UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25DBG629;  REF DYNJ905390F:  UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit Lot Number 25EBN370;  REF DYNJ905390F:  UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit Lot Number 25CBR398;  REF DYNJ905390G:  UDI/DI 10198459346309 (EA)40198459346300 (CS), Kit Lot Number 25FBS728;  REF DYNJ905407D:  UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit Lot Number 25EBI282;  REF DYNJ905407D:  UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit Lot Number 25CBK566;  REF DYNJ905413A:  UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit Lot Number 25EBK030;  REF DYNJ905413A:  UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit Lot Number 25DBF506;  REF DYNJ905413B:  UDI/DI 10198459346293 (EA)40198459346294 (CS), Kit Lot Number 25FBN971;  REF DYNJ905733K:  UDI/DI 10198459061493 (EA)40198459061494 (CS), Kit Lot Number 25DMI831;  REF DYNJ905856A:  UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25FBL810;  REF DYNJ905856A:  UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25EBN681;  REF DYNJ905856A:  UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25CBT634;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25FMA366;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25EMB405;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25DMJ507;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25CMI539; 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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-1086-2026&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-1086-2026&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-1086-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1086-2026 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1086-2026&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-1086-2026&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-1086-2026/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
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      "name": "FDA recall details — Z-1086-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1086-2026",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "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 kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-12-16",
            "Status": "recorded"
          }
        },
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 REF DYNJ67296D:  UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25CBI966;  REF DYNJ68187A:  UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit Lot Number 25FMB779;  REF DYNJ68187A:  UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit Lot Number 25DMD529;  REF DYNJ68741A:  UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit Lot Number 25DMH940;  REF DYNJ68741A:  UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit Lot Number 25BMH074;  REF DYNJ81408A:  UDI/DI 10198459133947 (EA)40198459133948 (CS), Kit Lot Number 25CMB055;  REF DYNJ81408B:  UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25FMC540;  REF DYNJ81408B:  UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25CMG686;  REF DYNJ81408B:  UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25CMD691;  REF DYNJ85318:  UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit Lot Number 25EBL562;  REF DYNJ85318:  UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit Lot Number 25CBP974;  REF DYNJ89677:  UDI/DI 10198459281716 (EA)40198459281717 (CS), Kit Lot Number 25CMF548;  REF DYNJ900969J:  UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit Lot Number 25DBP346;  REF DYNJ900969J:  UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit Lot Number 25CBH795;  REF DYNJ901126G:  UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit Lot Number 25FBE871;  REF DYNJ901126G:  UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit Lot Number 25EBG615;  REF DYNJ901145I:  UDI/DI 10195327603960 (EA)40195327603961 (CS), Kit Lot Number 25EBH921;  REF DYNJ901164M:  UDI/DI 10195327468675 (EA)40195327468676 (CS), Kit Lot Number 25DBR923;  REF DYNJ901504L:  UDI/DI 10195327524456 (EA)40195327524457 (CS), Kit Lot Number 25CBH718;  REF DYNJ901827X:  UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25FDA155;  REF DYNJ901827X:  UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25EDA571;  REF DYNJ901827X:  UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25CDA197;  REF DYNJ901847N:  UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25FBG897;  REF DYNJ901847N:  UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25EBJ874;  REF DYNJ901847N:  UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25DBM222;  REF DYNJ901848L:  UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit Lot Number 25FBH903;  REF DYNJ901848L:  UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit Lot Number 25EBH888;  REF DYNJ901870J:  UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit Lot Number 25EBV494;  REF DYNJ901870J:  UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit Lot Number 25DBD971;  REF DYNJ902033L:  UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit Lot Number 25EBQ971;  REF DYNJ902033L:  UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit Lot Number 25CBR575;  REF DYNJ902515K:  UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit Lot Number 25EBH883;  REF DYNJ902515K:  UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit Lot Number 25DBC358;  REF DYNJ902565K:  UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit Lot Number 25EMD967;  REF DYNJ902565K:  UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit Lot Number 25DMG347;  REF DYNJ902995I:  UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit Lot Number 25EMH930;  REF DYNJ902995I:  UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit Lot Number 25DMB723;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25EME835;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25DMJ465;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25DMF401;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25BMJ071;  REF DYNJ903164L:  UDI/DI 10198459222740 (EA)40198459222741 (CS), Kit Lot Number 25FMD784;  REF DYNJ903733C:  UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit Lot Number 25FBC756;  REF DYNJ903733C:  UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit Lot Number 25EBF091;  REF DYNJ904693D:  UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25HBJ124;  REF DYNJ904693D:  UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25FBF713;  REF DYNJ904693D:  UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25DBJ916;  REF DYNJ904891N:  UDI/DI 10198459071881 (EA)40198459071882 (CS), Kit Lot Number 25DBM300;  REF DYNJ905071F:  UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25EBO479;  REF DYNJ905071F:  UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25DBF405;  REF DYNJ905071F:  UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25DBG629;  REF DYNJ905390F:  UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit Lot Number 25EBN370;  REF DYNJ905390F:  UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit Lot Number 25CBR398;  REF DYNJ905390G:  UDI/DI 10198459346309 (EA)40198459346300 (CS), Kit Lot Number 25FBS728;  REF DYNJ905407D:  UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit Lot Number 25EBI282;  REF DYNJ905407D:  UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit Lot Number 25CBK566;  REF DYNJ905413A:  UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit Lot Number 25EBK030;  REF DYNJ905413A:  UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit Lot Number 25DBF506;  REF DYNJ905413B:  UDI/DI 10198459346293 (EA)40198459346294 (CS), Kit Lot Number 25FBN971;  REF DYNJ905733K:  UDI/DI 10198459061493 (EA)40198459061494 (CS), Kit Lot Number 25DMI831;  REF DYNJ905856A:  UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25FBL810;  REF DYNJ905856A:  UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25EBN681;  REF DYNJ905856A:  UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25CBT634;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25FMA366;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25EMB405;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25DMJ507;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25CMI539;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25CMD374;  REF DYNJ906302D:  UDI/DI 10198459080579 (EA)40198459080570 (CS), Kit Lot Number 25EBJ685;  REF DYNJ906302D:  UDI/DI 10198459080579 (EA)40198459080570 (CS), Kit Lot Number 25CBN214;  REF DYNJ906315D:  UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25EBP431;  REF DYNJ906315D:  UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25DBG969;  REF DYNJ906315D:  UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25CBD708;  REF DYNJ906355D:  UDI/DI 10198459130496 (EA)40198459130497 (CS), Kit Lot Number 25CBR473;  REF DYNJ906805C:  UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25EBO230;  REF DYNJ906805C:  UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25DBN709;  REF DYNJ906805C:  UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25CBF802;  REF DYNJ906824C:  UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25FBJ387;  REF DYNJ906824C:  UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25EBG494;  REF DYNJ906824C:  UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25DBF817;  REF DYNJ907639D:  UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25FBL808;  REF DYNJ907639D:  UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25EBO292;  REF DYNJ907639D:  UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25CBU472;  REF DYNJ907639D:  UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25CBF619;  REF DYNJ908415B:  UDI/DI 10195327624156 (EA)40195327624157 (CS), Kit Lot Number 25CLA613;  REF DYNJ908415B:  UDI/DI 10195327624156 (EA)40195327624157 (CS), Kit Lot Number 25BLA456;  REF DYNJ908415C:  UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25FLA028;  REF DYNJ908415C:  UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25ELA953;  REF DYNJ908415C:  UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25DLA736;  REF DYNJ908569B:  UDI/DI 10195327591182 (EA)40195327591183 (CS), Kit Lot Number 25EBK350;  REF DYNJ908569B:  UDI/DI 10195327591182 (EA)40195327591183 (CS), Kit Lot Number 25BBI977;  REF DYNJ909119G:  UDI/DI 10198459130526 (EA)40198459130527 (CS), Kit Lot Number 25FBP681;  REF DYNJ909119G:  UDI/DI 10198459130526 (EA)40198459130527 (CS), Kit Lot Number 25CBM187;  REF DYNJ909628A:  UDI/DI 10198459013751 (EA)40198459013752 (CS), Kit Lot Number 25EBB901;  REF DYNJ909817A:  UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25FBP547;  REF DYNJ909817A:  UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25FBG101;  REF DYNJ909817A:  UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25EBK620;  REF DYNJ910050:  UDI/DI 10195327552657 (EA)40195327552658 (CS), Kit Lot Number 25EMA608;  REF DYNJ910050:  UDI/DI 10195327552657 (EA)40195327552658 (CS), Kit Lot Number 25CMI012;  REF DYNJ910139A:  UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25FBU030;  REF DYNJ910139A:  UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25FBB531;  REF DYNJ910139A:  UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25DBO255;  REF DYNJ910386:  UDI/DI 10195327661854 (EA)40195327661855 (CS), Kit Lot Number 25EMF578;  REF DYNJ910386:  UDI/DI 10195327661854 (EA)40195327661855 (CS), Kit Lot Number 25DMG348;  REF DYNJ911017:  UDI/DI 10198459234316 (EA)40198459234317 (CS), Kit Lot Number 25FBR251;  REF DYNJ911017:  UDI/DI 10198459234316 (EA)40198459234317 (CS), Kit Lot Number 25FBE132.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}