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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1057-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) PRE OP KIT, Medline kit SKU DYKS1093B;   2) PRE OP KIT, Medline kit SKU DYKS1124C;   3) PRE OP KIT, Medline kit SKU DYKS1128C;   4) PREOP KIT, Medline kit SKU DYKS1130B;   5) PRE OP KIT, Medline kit SKU DYKS1163G;   6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G;   7) PREOP KIT, Medline kit SKU DYKS1313A;   8) PRE OP KIT, Medline kit SKU DYKS1325A;   9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D;   10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A;   11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B;   12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B;   13) PRE OP KIT, Medline kit SKU DYKS1382A;   14) PRE OP KIT, Medline kit SKU DYKS1416F;   15) PREOP KIT, Medline kit SKU DYKS1448B;   16) PRE-OP KIT, Medline kit SKU DYKS1458F;   17) PRE OP KIT, Medline kit SKU DYKS1467B;   18) PRE OP KIT, Medline kit SKU DYKS1468;   19) PRE-OP, Medline kit SKU DYKS1482A;   20) ADULT PRE OP, Medline kit SKU DYKS1487I;   21) PRE OP ENDO, Medline kit SKU DYKS1489F;   22) PREOP KIT, Medline kit SKU DYKS1507B;   23) PRE OP KIT, Medline kit SKU DYKS1518A;   24) PRE OP KIT, Medline kit SKU DYKS1544F;   25) PREOP, Medline kit SKU DYKS1551B;   26) PREOP, Medline kit SKU DYKS1552B;   27) PREOP, Medline kit SKU DYKS1580;   28) PRE OP KIT, Medline kit SKU DYKS2024A;   29) PRE OP KIT, Medline kit SKU DYKS2056A;   30) PRE-OP KIT, Medline kit SKU DYKS2074;   31) PRE-OP KIT, Medline kit SKU DYKS2074A;   32) PREOP KIT, Medline kit SKU DYKS2076;   33) PRE OP KIT 1, Medline kit SKU DYKS2083;   34) PRE OP KIT, Medline kit SKU DYKS2103.",
  "description": "FDA recall Z-1057-2026 — Medline Industries, LP is recalling Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) PRE OP KIT, Medline kit SKU DYKS1093B;   2) PRE OP KIT, Medline kit SKU DYKS1124C;   3) PRE OP KIT, Medline kit SKU DYKS1128C;   4) PREOP KIT, Medline kit SKU DYKS1130B;   5) PRE OP KIT, Medline kit SKU DYKS1163G;   6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G;   7) PREOP KIT, Medline kit SKU DYKS1313A;   8) PRE OP KIT, Medline kit SKU DYKS1325A;   9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D;   10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A;   11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B;   12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B;   13) PRE OP KIT, Medline kit SKU DYKS1382A;   14) PRE OP KIT, Medline kit SKU DYKS1416F;   15) PREOP KIT, Medline kit SKU DYKS1448B;   16) PRE-OP KIT, Medline kit SKU DYKS1458F;   17) PRE OP KIT, Medline kit SKU DYKS1467B;   18) PRE OP KIT, Medline kit SKU DYKS1468;   19) PRE-OP, Medline kit SKU DYKS1482A;   20) ADULT PRE OP, Medline kit SKU DYKS1487I;   21) PRE OP ENDO, Medline kit SKU DYKS1489F;   22) PREOP KIT, Medline kit SKU DYKS1507B;   23) PRE OP KIT, Medline kit SKU DYKS1518A;   24) PRE OP KIT, Medline kit SKU DYKS1544F;   25) PREOP, Medline kit SKU DYKS1551B;   26) PREOP, Medline kit SKU DYKS1552B;   27) PREOP, Medline kit SKU DYKS1580;   28) PRE OP KIT, Medline kit SKU DYKS2024A;   29) PRE OP KIT, Medline kit SKU DYKS2056A;   30) PRE-OP KIT, Medline kit SKU DYKS2074;   31) PRE-OP KIT, Medline kit SKU DYKS2074A;   32) PREOP KIT, Medline kit SKU DYKS2076;   33) PRE OP KIT 1, Medline kit SKU DYKS2083;   34) PRE OP KIT, Medline kit SKU DYKS2103. (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/",
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  "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": {
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      "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-1057-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) PRE OP KIT, Medline kit SKU DYKS1093B;   2) PRE OP KIT, Medline kit SKU DYKS1124C;   3) PRE OP KIT, Medline kit SKU DYKS1128C;   4) PREOP KIT, Medline kit SKU DYKS1130B;   5) PRE OP KIT, Medline kit SKU DYKS1163G;   6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G;   7) PREOP KIT, Medline kit SKU DYKS1313A;   8) PRE OP KIT, Medline kit SKU DYKS1325A;   9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D;   10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A;   11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B;   12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B;   13) PRE OP KIT, Medline kit SKU DYKS1382A;   14) PRE OP KIT, Medline kit SKU DYKS1416F;   15) PREOP KIT, Medline kit SKU DYKS1448B;   16) PRE-OP KIT, Medline kit SKU DYKS1458F;   17) PRE OP KIT, Medline kit SKU DYKS1467B;   18) PRE OP KIT, Medline kit SKU DYKS1468;   19) PRE-OP, Medline kit SKU DYKS1482A;   20) ADULT PRE OP, Medline kit SKU DYKS1487I;   21) PRE OP ENDO, Medline kit SKU DYKS1489F;   22) PREOP KIT, Medline kit SKU DYKS1507B;   23) PRE OP KIT, Medline kit SKU DYKS1518A;   24) PRE OP KIT, Medline kit SKU DYKS1544F;   25) PREOP, Medline kit SKU DYKS1551B;   26) PREOP, Medline kit SKU DYKS1552B;   27) PREOP, Medline kit SKU DYKS1580;   28) PRE OP KIT, Medline kit SKU DYKS2024A;   29) PRE OP KIT, Medline kit SKU DYKS2056A;   30) PRE-OP KIT, Medline kit SKU DYKS2074;   31) PRE-OP KIT, Medline kit SKU DYKS2074A;   32) PREOP KIT, Medline kit SKU DYKS2076;   33) PRE OP KIT 1, Medline kit SKU DYKS2083;   34) PRE OP KIT, Medline kit SKU DYKS2103.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1057-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1057-2026: Medline Industries, LP is recalling Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) PRE OP KIT, Medline kit SKU DYKS1093B;   2) PRE OP KIT, Medline kit SKU DYKS1124C;   3) PRE OP KIT, Medline kit SKU DYKS1128C;   4) PREOP KIT, Medline kit SKU DYKS1130B;   5) PRE OP KIT, Medline kit SKU DYKS1163G;   6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G;   7) PREOP KIT, Medline kit SKU DYKS1313A;   8) PRE OP KIT, Medline kit SKU DYKS1325A;   9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D;   10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A;   11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B;   12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B;   13) PRE OP KIT, Medline kit SKU DYKS1382A;   14) PRE OP KIT, Medline kit SKU DYKS1416F;   15) PREOP KIT, Medline kit SKU DYKS1448B;   16) PRE-OP KIT, Medline kit SKU DYKS1458F;   17) PRE OP KIT, Medline kit SKU DYKS1467B;   18) PRE OP KIT, Medline kit SKU DYKS1468;   19) PRE-OP, Medline kit SKU DYKS1482A;   20) ADULT PRE OP, Medline kit SKU DYKS1487I;   21) PRE OP ENDO, Medline kit SKU DYKS1489F;   22) PREOP KIT, Medline kit SKU DYKS1507B;   23) PRE OP KIT, Medline kit SKU DYKS1518A;   24) PRE OP KIT, Medline kit SKU DYKS1544F;   25) PREOP, Medline kit SKU DYKS1551B;   26) PREOP, Medline kit SKU DYKS1552B;   27) PREOP, Medline kit SKU DYKS1580;   28) PRE OP KIT, Medline kit SKU DYKS2024A;   29) PRE OP KIT, Medline kit SKU DYKS2056A;   30) PRE-OP KIT, Medline kit SKU DYKS2074;   31) PRE-OP KIT, Medline kit SKU DYKS2074A;   32) PREOP KIT, Medline kit SKU DYKS2076;   33) PRE OP KIT 1, Medline kit SKU DYKS2083;   34) PRE OP KIT, Medline kit SKU DYKS2103.",
      "text": "The FDA logged enforcement record Z-1057-2026: Medline Industries, LP is voluntarily recalling Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) PRE OP KIT, Medline kit SKU DYKS1093B;   2) PRE OP KIT, Medline kit SKU DYKS1124C;   3) PRE OP KIT, Medline kit SKU DYKS1128C;   4) PREOP KIT, Medline kit SKU DYKS1130B;   5) PRE OP KIT, Medline kit SKU DYKS1163G;   6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G;   7) PREOP KIT, Medline kit SKU DYKS1313A;   8) PRE OP KIT, Medline kit SKU DYKS1325A;   9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D;   10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A;   11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B;   12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B;   13) PRE OP KIT, Medline kit SKU DYKS1382A;   14) PRE OP KIT, Medline kit SKU DYKS1416F;   15) PREOP KIT, Medline kit SKU DYKS1448B;   16) PRE-OP KIT, Medline kit SKU DYKS1458F;   17) PRE OP KIT, Medline kit SKU DYKS1467B;   18) PRE OP KIT, Medline kit SKU DYKS1468;   19) PRE-OP, Medline kit SKU DYKS1482A;   20) ADULT PRE OP, Medline kit SKU DYKS1487I;   21) PRE OP ENDO, Medline kit SKU DYKS1489F;   22) PREOP KIT, Medline kit SKU DYKS1507B;   23) PRE OP KIT, Medline kit SKU DYKS1518A;   24) PRE OP KIT, Medline kit SKU DYKS1544F;   25) PREOP, Medline kit SKU DYKS1551B;   26) PREOP, Medline kit SKU DYKS1552B;   27) PREOP, Medline kit SKU DYKS1580;   28) PRE OP KIT, Medline kit SKU DYKS2024A;   29) PRE OP KIT, Medline kit SKU DYKS2056A;   30) PRE-OP KIT, Medline kit SKU DYKS2074;   31) PRE-OP KIT, Medline kit SKU DYKS2074A;   32) PREOP KIT, Medline kit SKU DYKS2076;   33) PRE OP KIT 1, Medline kit SKU DYKS2083;   34) PRE OP KIT, Medline kit SKU DYKS2103. — reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-11-26. Affected lots/codes: Medline kit SKU DYKS1378B, UDI/DI 10195327521660 (EA) 40195327521661 (CS), Lot Number 25HBB410;  Medline kit SKU DYKS1448B, UDI/DI 10195327691349 (EA) 40195327691340 (CS), Lot Number 25HBE055;  Medline kit SKU DYKS1163G, UDI/DI 10195327503185 (EA) 40195327503186 (CS), Lot Number 25HBF057;  Medline kit SKU DYKS1487I, UDI/DI 10198459415678 (EA) 40198459415679 (CS), Lot Number 25HBI512;  Medline kit SKU DYKS2056A, UDI/DI 10198459467493 (EA) 40198459467494 (CS), Lot Number 25HBK906;  Medline kit SKU DYKS2074, UDI/DI 10198459399893 (EA) 40198459399894 (CS), Lot Number 25HBV987;  Medline kit SKU DYKS2083, UDI/DI 10198459435126 (EA) 40198459435127 (CS), Lot Number 25HLA076;  Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS), Lot Number 25HLA432;  Medline kit SKU DYKS1362A, UDI/DI 10195327343163 (EA) 40195327343164 (CS), Lot Number 25HLA829;  Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25HMB303;  Medline kit SKU DYKS1313A, UDI/DI 10198459370595 (EA) 40198459370596 (CS), Lot Number 25HMB948;  Medline kit SKU DYKS1544F, UDI/DI 10198459411700 (EA) 40198459411701 (CS), Lot Number 25HMC488;  Medline kit SKU DYKS1507B, UDI/DI 10198459489372 (EA) 40198459489373 (CS), Lot Number 25HMD440;  Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25HMF480;  Medline kit SKU DYKS1130B, UDI/DI 10198459377129 (EA) 40198459377120 (CS), Lot Number 25IBC508;  Medline kit SKU DYKS1378B, UDI/DI 10195327521660 (EA) 40195327521661 (CS), Lot Number 25IBI706;  Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS), Lot Number 25IBK720;  Medline kit SKU DYKS1580, UDI/DI 10198459024320 (EA) 40198459024321 (CS), Lot Number 25IBL590;  Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS), Lot Number 25IBL885;  Medline kit SKU DYKS1163G, UDI/DI 10195327503185 (EA) 40195327503186 (CS), Lot Number 25IBQ969;  Medline kit SKU DYKS1518A, UDI/DI 10198459032448 (EA) 40198459032449 (CS), Lot Number 25IBU385;  Medline kit SKU DYKS1489F, UDI/DI 10198459291272 (EA) 40198459291273 (CS), Lot Number 25IBW167;  Medline kit SKU DYKS1337D, UDI/DI 10198459078415 (EA) 40198459078416 (CS), Lot Number 25ILA943;  Medline kit SKU DYKS1468, UDI/DI 10195327411213 (EA) 40195327411214 (CS), Lot Number 25ILA944;  Medline kit SKU DYKS1467B, UDI/DI 10198459025648 (EA) 40198459025649 (CS), Lot Number 25IME692;  Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS), Lot Number 25JBB244;  Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS), Lot Number 25JBC342;  Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS), Lot Number 25JBE269;  Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS), Lot Number 25JBE865;  Medline kit SKU DYKS1128C, UDI/DI 10195327549374 (EA) 40195327549375 (CS), Lot Number 25JBG502;  Medline kit SKU DYKS1487I, UDI/DI 10198459415678 (EA) 40198459415679 (CS), Lot Number 25JBJ439;  Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS), Lot Number 25JBJ451;  Medline kit SKU DYKS1263G, UDI/DI 10198459557330 (EA) 40198459557331 (CS), Lot Number 25JBL575;  Medline kit SKU DYKS1448B, UDI/DI 10195327691349 (EA) 40195327691340 (CS), Lot Number 25JBO961;  Medline kit SKU DYKS1482A, UDI/DI 10198459011368 (EA) 40198459011369 (CS), Lot Number 25JBR391;  Medline kit SKU DYKS1382A, UDI/DI 10195327482602 (EA) 40195327482603 (CS), Lot Number 25JBS091;  Medline kit SKU DYKS1580, UDI/DI 10198459024320 (EA) 40198459024321 (CS), Lot Number 25JBU194;  Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS), Lot Number 25JBU341;  Medline kit SKU DYKS1325A, UDI/DI 10195327549343 (EA) 40195327549344 (CS), Lot Number 25JBU577;  Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS), Lot Number 25JLA660;  Medline kit SKU DYKS1458F, UDI/DI 10198459477942 (EA) 40198459477943 (CS), Lot Number 25JLA986;  Medline kit SKU DYKS1416F, UDI/DI 10198459508561 (EA) 40198459508562 (CS), Lot Number 25JLB077;  Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25JMD403;  Medline kit SKU DYKS1544F, UDI/DI 10198459411700 (EA) 40198459411701 (CS), Lot Number 25JMD404;  Medline kit SKU DYKS1093B, UDI/DI 10198459544545 (EA) 40198459544546 (CS), Lot Number 25JMF248;  Medline kit SKU DYKS1313A, UDI/DI 10198459370595 (EA) 40198459370596 (CS), Lot Number 25JMH456;  Medline kit SKU DYKS2103, UDI/DI 10198459550539 (EA) 40198459550530 (CS), Lot Number 25JML466;  Medline kit SKU DYKS2024A, UDI/DI 10198459547201 (EA) 40198459547202 (CS), Lot Number 25KBC077;  Medline kit SKU DYKS1128C, UDI/DI 10195327549374 (EA) 40195327549375 (CS), Lot Number 25KBH159;  Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS), Lot Number 25KBL301;  Medline kit SKU DYKS1362A, UDI/DI 10195327343163 (EA) 40195327343164 (CS), Lot Number 25KLA016;  Medline kit SKU DYKS1468, UDI/DI 10195327411213 (EA) 40195327411214 (CS), Lot Number 25KLA028;  Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS), Lot Number 25KLA029;  Medline kit SKU DYKS1337D, UDI/DI 10198459078415 (EA) 40198459078416 (CS), Lot Number 25KLA107;  Medline kit SKU DYKS1467B, UDI/DI 10198459025648 (EA) 40198459025649 (CS), Lot Number 25KME034;  Medline kit SKU DYKS2074A, UDI/DI 10198459528651 (EA) 40198459528652 (CS), Lot Number 25KME090.. 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-1057-2026&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-1057-2026&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-1057-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1057-2026 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-1057-2026&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-1057-2026&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-1057-2026/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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            "Field": "Reason",
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          "item": {
            "Field": "Initiated",
            "Value": "2025-11-26",
            "Status": "recorded"
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