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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1087-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical procedure convenience kits labeled as:    1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF;   2) ROBOTIC PROCEDURE, REF CDS982128Q;   3) CUH THORACIC, REF CDS984338M;   4) THORACIC PROCEDURE, REF CDS984640I;   5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O;   6) LAP CHOLE PACK, REF DYNJ57640F;   7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D;   8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D;   9) LAPAROSCOPY PACK, REF DYNJ68187B;   10) LAPAROSCOPY PACK, REF DYNJ82368A;   11) ROBOTIC KIDNEY PACK, REF DYNJ85261;   12) DOWNTOWN ROBOTICS, REF DYNJ86178B;   13) DAVINCI LITHOTOMY PACK, REF DYNJ87610;   14) ROBOTIC WHIPPLE PACK, REF DYNJ88433;   15) PROSTATE DAVINCI, REF DYNJ900127G;   16) GENERAL LAPAROSCOPY, REF DYNJ901847M;   17) LAG TLH, REF DYNJ901890N;   18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S;   19) LAP, REF DYNJ904576B;   20) ROBOTIC, REF DYNJ905147B;   21) ROBOTICS GYN, REF DYNJ905824M;   22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B;   23) CHN OR BASIC ROBOTIC, REF DYNJ905982I;   24) KIT ROBOTIC RFD, REF DYNJ906311F;   25) ROBOTIC PROSTATE, REF DYNJ906381G;   26) DAVINCI, REF DYNJ907392C;   27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C;   28) GYN, REF DYNJ908504B;   29) UROLOGY ROBOTIC, REF DYNJ908588I;   30) THORACIC ROBOTICS, REF DYNJ908777A;   31) GENERAL ROBOT, REF DYNJ908969A;   32) KIT ROBOTIC, REF DYNJ909870B;   33) ROBOTIC THORACOSCOPY, REF DYNJ910924.",
  "description": "FDA recall Z-1087-2026 — Medline Industries, LP is recalling Medline medical procedure convenience kits labeled as:    1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF;   2) ROBOTIC PROCEDURE, REF CDS982128Q;   3) CUH THORACIC, REF CDS984338M;   4) THORACIC PROCEDURE, REF CDS984640I;   5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O;   6) LAP CHOLE PACK, REF DYNJ57640F;   7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D;   8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D;   9) LAPAROSCOPY PACK, REF DYNJ68187B;   10) LAPAROSCOPY PACK, REF DYNJ82368A;   11) ROBOTIC KIDNEY PACK, REF DYNJ85261;   12) DOWNTOWN ROBOTICS, REF DYNJ86178B;   13) DAVINCI LITHOTOMY PACK, REF DYNJ87610;   14) ROBOTIC WHIPPLE PACK, REF DYNJ88433;   15) PROSTATE DAVINCI, REF DYNJ900127G;   16) GENERAL LAPAROSCOPY, REF DYNJ901847M;   17) LAG TLH, REF DYNJ901890N;   18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S;   19) LAP, REF DYNJ904576B;   20) ROBOTIC, REF DYNJ905147B;   21) ROBOTICS GYN, REF DYNJ905824M;   22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B;   23) CHN OR BASIC ROBOTIC, REF DYNJ905982I;   24) KIT ROBOTIC RFD, REF DYNJ906311F;   25) ROBOTIC PROSTATE, REF DYNJ906381G;   26) DAVINCI, REF DYNJ907392C;   27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C;   28) GYN, REF DYNJ908504B;   29) UROLOGY ROBOTIC, REF DYNJ908588I;   30) THORACIC ROBOTICS, REF DYNJ908777A;   31) GENERAL ROBOT, REF DYNJ908969A;   32) KIT ROBOTIC, REF DYNJ909870B;   33) ROBOTIC THORACOSCOPY, REF DYNJ910924. (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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1087-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical procedure convenience kits labeled as:    1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF;   2) ROBOTIC PROCEDURE, REF CDS982128Q;   3) CUH THORACIC, REF CDS984338M;   4) THORACIC PROCEDURE, REF CDS984640I;   5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O;   6) LAP CHOLE PACK, REF DYNJ57640F;   7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D;   8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D;   9) LAPAROSCOPY PACK, REF DYNJ68187B;   10) LAPAROSCOPY PACK, REF DYNJ82368A;   11) ROBOTIC KIDNEY PACK, REF DYNJ85261;   12) DOWNTOWN ROBOTICS, REF DYNJ86178B;   13) DAVINCI LITHOTOMY PACK, REF DYNJ87610;   14) ROBOTIC WHIPPLE PACK, REF DYNJ88433;   15) PROSTATE DAVINCI, REF DYNJ900127G;   16) GENERAL LAPAROSCOPY, REF DYNJ901847M;   17) LAG TLH, REF DYNJ901890N;   18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S;   19) LAP, REF DYNJ904576B;   20) ROBOTIC, REF DYNJ905147B;   21) ROBOTICS GYN, REF DYNJ905824M;   22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B;   23) CHN OR BASIC ROBOTIC, REF DYNJ905982I;   24) KIT ROBOTIC RFD, REF DYNJ906311F;   25) ROBOTIC PROSTATE, REF DYNJ906381G;   26) DAVINCI, REF DYNJ907392C;   27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C;   28) GYN, REF DYNJ908504B;   29) UROLOGY ROBOTIC, REF DYNJ908588I;   30) THORACIC ROBOTICS, REF DYNJ908777A;   31) GENERAL ROBOT, REF DYNJ908969A;   32) KIT ROBOTIC, REF DYNJ909870B;   33) ROBOTIC THORACOSCOPY, REF DYNJ910924.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1087-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1087-2026: Medline Industries, LP is recalling Medline medical procedure convenience kits labeled as:    1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF;   2) ROBOTIC PROCEDURE, REF CDS982128Q;   3) CUH THORACIC, REF CDS984338M;   4) THORACIC PROCEDURE, REF CDS984640I;   5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O;   6) LAP CHOLE PACK, REF DYNJ57640F;   7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D;   8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D;   9) LAPAROSCOPY PACK, REF DYNJ68187B;   10) LAPAROSCOPY PACK, REF DYNJ82368A;   11) ROBOTIC KIDNEY PACK, REF DYNJ85261;   12) DOWNTOWN ROBOTICS, REF DYNJ86178B;   13) DAVINCI LITHOTOMY PACK, REF DYNJ87610;   14) ROBOTIC WHIPPLE PACK, REF DYNJ88433;   15) PROSTATE DAVINCI, REF DYNJ900127G;   16) GENERAL LAPAROSCOPY, REF DYNJ901847M;   17) LAG TLH, REF DYNJ901890N;   18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S;   19) LAP, REF DYNJ904576B;   20) ROBOTIC, REF DYNJ905147B;   21) ROBOTICS GYN, REF DYNJ905824M;   22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B;   23) CHN OR BASIC ROBOTIC, REF DYNJ905982I;   24) KIT ROBOTIC RFD, REF DYNJ906311F;   25) ROBOTIC PROSTATE, REF DYNJ906381G;   26) DAVINCI, REF DYNJ907392C;   27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C;   28) GYN, REF DYNJ908504B;   29) UROLOGY ROBOTIC, REF DYNJ908588I;   30) THORACIC ROBOTICS, REF DYNJ908777A;   31) GENERAL ROBOT, REF DYNJ908969A;   32) KIT ROBOTIC, REF DYNJ909870B;   33) ROBOTIC THORACOSCOPY, REF DYNJ910924.",
      "text": "The FDA logged enforcement record Z-1087-2026: Medline Industries, LP is voluntarily recalling Medline medical procedure convenience kits labeled as:    1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF;   2) ROBOTIC PROCEDURE, REF CDS982128Q;   3) CUH THORACIC, REF CDS984338M;   4) THORACIC PROCEDURE, REF CDS984640I;   5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O;   6) LAP CHOLE PACK, REF DYNJ57640F;   7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D;   8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D;   9) LAPAROSCOPY PACK, REF DYNJ68187B;   10) LAPAROSCOPY PACK, REF DYNJ82368A;   11) ROBOTIC KIDNEY PACK, REF DYNJ85261;   12) DOWNTOWN ROBOTICS, REF DYNJ86178B;   13) DAVINCI LITHOTOMY PACK, REF DYNJ87610;   14) ROBOTIC WHIPPLE PACK, REF DYNJ88433;   15) PROSTATE DAVINCI, REF DYNJ900127G;   16) GENERAL LAPAROSCOPY, REF DYNJ901847M;   17) LAG TLH, REF DYNJ901890N;   18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S;   19) LAP, REF DYNJ904576B;   20) ROBOTIC, REF DYNJ905147B;   21) ROBOTICS GYN, REF DYNJ905824M;   22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B;   23) CHN OR BASIC ROBOTIC, REF DYNJ905982I;   24) KIT ROBOTIC RFD, REF DYNJ906311F;   25) ROBOTIC PROSTATE, REF DYNJ906381G;   26) DAVINCI, REF DYNJ907392C;   27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C;   28) GYN, REF DYNJ908504B;   29) UROLOGY ROBOTIC, REF DYNJ908588I;   30) THORACIC ROBOTICS, REF DYNJ908777A;   31) GENERAL ROBOT, REF DYNJ908969A;   32) KIT ROBOTIC, REF DYNJ909870B;   33) ROBOTIC THORACOSCOPY, REF DYNJ910924. — 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 CDS860237AF:  UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25FBK870;  REF CDS860237AF:  UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25EBD110;  REF CDS982128Q:  UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25EBC253;  REF CDS982128Q:  UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25DBG393;  REF CDS984338M:  UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25FBQ303;  REF CDS984338M:  UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25EBD631;  REF CDS984338M:  UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25DBM322;  REF CDS984640I:  UDI/DI 10198459318955 (EA) 40198459318956 (CS), Lot Number 25DBT807;  REF DYNJ0525321O:  UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25DMG099;  REF DYNJ0525321O:  UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25CMJ006;  REF DYNJ57640F:  UDI/DI 10198459011115 (EA) 40198459011116 (CS), Lot Number 25FDB347;  REF DYNJ62594D:  UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25EBK539;  REF DYNJ62594D:  UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25DBD145;  REF DYNJ63392D:  UDI/DI 10198459164507 (EA) 40198459164508 (CS), Lot Number 25BLA967;  REF DYNJ68187B:  UDI/DI 10198459382086 (EA) 40198459382087 (CS), Lot Number 25FMG440;  REF DYNJ82368A:  UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25EMH020;  REF DYNJ82368A:  UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25CMF917;  REF DYNJ85261:  UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25FBK331;  REF DYNJ85261:  UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25EBR783;  REF DYNJ86178B:  UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBP320;  REF DYNJ86178B:  UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBC981;  REF DYNJ86178B:  UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25DBA834;  REF DYNJ86178B:  UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25CBM884;  REF DYNJ87610:  UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25FBK123;  REF DYNJ87610:  UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25EBF929;  REF DYNJ87610:  UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25CBT135;  REF DYNJ88433:  UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25FMC215;  REF DYNJ88433:  UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMF199;  REF DYNJ88433:  UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMC621;  REF DYNJ900127G:  UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25FBO994;  REF DYNJ900127G:  UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25EBE439;  REF DYNJ901847M:  UDI/DI 10198459037863 (EA) 40198459037864 (CS), Lot Number 25BBM364;  REF DYNJ901890N:  UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25FBJ408;  REF DYNJ901890N:  UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25EBJ877;  REF DYNJ903948S:  UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBO236;  REF DYNJ903948S:  UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBC133;  REF DYNJ904576B:  UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMH506;  REF DYNJ904576B:  UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMD329;  REF DYNJ905147B:  UDI/DI 10193489569032 (EA) 40193489569033 (CS), Lot Number 25GDB060;  REF DYNJ905824M:  UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25DMK337;  REF DYNJ905824M:  UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25CMF465;  REF DYNJ905920B:  UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25EBG945;  REF DYNJ905920B:  UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25CBM218;  REF DYNJ905982I:  UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25EMD118;  REF DYNJ905982I:  UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25DMJ823;  REF DYNJ905982I:  UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMJ265;  REF DYNJ905982I:  UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC374;  REF DYNJ905982I:  UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC546;  REF DYNJ906311F:  UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25EBI860;  REF DYNJ906311F:  UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25DBR934;  REF DYNJ906311F:  UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25CBF096;  REF DYNJ906381G:  UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBJ655;  REF DYNJ906381G:  UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBE873;  REF DYNJ906381G:  UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25EBB258;  REF DYNJ906381G:  UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25DBR935;  REF DYNJ907392C:  UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25DMH137;  REF DYNJ907392C:  UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25CMJ730;  REF DYNJ907405C:  UDI/DI 10195327541392 (EA) 40195327541393 (CS), Lot Number 25CMF429;  REF DYNJ908504B:  UDI/DI 10198459318221 (EA) 40198459318222 (CS), Lot Number 25FBG752;  REF DYNJ908504B:  UDI/DI 10198459318221 (EA) 40198459318222 (CS), Lot Number 25DBS537;  REF DYNJ908588I:  UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25FDA930;  REF DYNJ908588I:  UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25EDB953;  REF DYNJ908588I:  UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25EDA576;  REF DYNJ908588I:  UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25DDA437;  REF DYNJ908588I:  UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25CDB060;  REF DYNJ908777A:  UDI/DI 10195327415174 (EA) 40195327415175 (CS), Lot Number 25CBA577;  REF DYNJ908777A:  UDI/DI 10195327415174 (EA) 40195327415175 (CS), Lot Number 25CBA577Z;  REF DYNJ908969A:  UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25EBI127;  REF DYNJ908969A:  UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25CBP413;  REF DYNJ908969A:  UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25CBD522;  REF DYNJ909870B:  UDI/DI 10198459122446 (EA) 40198459122447 (CS), Lot Number 25EBF813;  REF DYNJ909870B:  UDI/DI 10198459122446 (EA) 40198459122447 (CS), Lot Number 25DBD407;  REF DYNJ910924:  UDI/DI 10198459203442 (EA) 40198459203443 (CS), Lot Number 25EBK656.. 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-1087-2026&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-1087-2026&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-1087-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1087-2026 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-1087-2026&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-1087-2026&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-1087-2026/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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            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
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            "Field": "Classification",
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medline Industries, LP",
            "Status": "recorded"
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          "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"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-12-16",
            "Status": "recorded"
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