{
  "@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-1639-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "BD PYXIS MEDBANK (Name, REF):  MEDPASS MODULE, 139088-01;  MINI 1FH-1FM, 169-137;  MINI 1HH-1FH-1HM, 169-101;  MINI 1HH-1HM-1FM, 169-102;  MINI 2FH, 138902-01;  MINI 2FH, 169-104;  MINI 2FM, 169-105;  MINI 2HH-1FH, 169-106;  MINI 2HH-1FH, 138908-01;  MINI 2HH-1FM, 169-107;  MINI 2HH-1FM, 138906-01;  MINI 3HH-1FG, 169-110;  MINI 3HH-1FG, 139091-01;  MINI 3HH-1HM, 169-111;  MINI 4HH, 138910-01;  MINI 4HH, 169-112;  MINI 4HM, 169-113;  MINI 4HM, 138915-01;  TWR MN 10HH-1FH-1FM, 169-23;  TWR MN 10HH-2FH, 169-24;  TWR MN 10HH-2FH, 138955-01;  TWR MN 10HH-2FM, 169-25;  TWR MN 10HH-2FM, 138924-01;  TWR MN 12HH-1FF, 169-26;  TWR MN 12HH-1FF, 138960-01;  TWR MN 12HH-1FH, 169-27;  TWR MN 12HH-1FH, 138961-01;  TWR MN 12HH-1FM, 169-28;  TWR MN 12HH-1FM, 138926-01;  TWR MN 14HH, 138927-01;  TWR MN 14HH, 169-29;  TWR MN 1HH-1HM-2FM-4FF, 169-30;  TWR MN 2FH-2HM-4FM, 169-31;  TWR MN 2HH-10HM-1FM, 169-32;  TWR MN 2HH-1FH-5FM, 169-33;  TWR MN 2HH-2FH-4FM, 169-34;  TWR MN 2HH-4FH-2FM, 169-139;  TWR MN 2HH-4HM-4FM, 139125-01;  TWR MN 2HH-6FM, 169-38;  TWR MN 2HH-6FM, 138919-01;  TWR MN 2HH-6HM-3FM, 169-39;  TWR MN 2HH-8HM-2FM, 169-40;  TWR MN 2HM-6FM, 169-41;  TWR MN 3FH-4FM, 169-42;  TWR MN 3FH-4FM, 138933-01;  TWR MN 3FH-8HH MEDPASS, 169-140;  TWR MN 3HH-7HM-2FM, 169-43;  TWR MN 4HH-10HM, 169-44;  TWR MN 4HH-10HM, 138959-01;  TWR MN 4HH-1FH-2HM-3FM, 169-45;  TWR MN 4HH-1FH-4FM, 169-46;  TWR MN 4HH-1FH-4HM-2FM, 169-47;  TWR MN 4HH-2FH-2HM-2FM, 169-49;  TWR MN 4HH-2FH-3FM, 169-50;  TWR MN 4HH-2FH-3FM, 138931-01;  TWR MN 4HH-3FH-2FM, 169-52;  TWR MN 4HH-4FH-1FM, 169-53;  TWR MN 4HH-4FH-1FM, 138940-01;  TWR MN 4HH-4HM-3FM, 169-54;  TWR MN 4HH-4HM-3FM, 138952-01;  TWR MN 4HH-5FH, 169-55;  TWR MN 4HH-5FM, 169-56;  TWR MN 4HH-5FM, 138918-01;  TWR MN 4HH-6HM-2FM, 169-57;  TWR MN 4HM-5FM, 169-59;  TWR MN 5HH-3HM-3FM, 169-60;  TWR MN 5HH-9HM, 138914-01;  TWR MN 5HH-9HM, 169-61;  TWR MN 6FH-1FM, 169-62;  TWR MN 6HH-1FH-2HM-2FM, 169-63;  TWR MN 6HH-1FH-3FM, 169-64;  TWR MN 6HH-2FH-2FM, 169-65;  TWR MN 6HH-4FH, 169-67;  TWR MN 6HH-4FH, 138957-01;  TWR MN 6HH-4FM, 169-68;  TWR MN 6HH-4FM, 138922-01;  TWR MN 6HH-4HM-2FM, 169-69;  TWR MN 6HH-8HM, 169-71;  TWR MN 6HH-8HM, 138958-01;  TWR MN 7FH, 169-72;  TWR MN 7FH, 138920-01;  TWR MN 7FM, 169-73;  TWR MN 7FM, 138937-01;  TWR MN 7HH-1HM-3FM, 139086-01;  TWR MN 7HH-1HM-3FM, 169-74;  TWR MN 8HH-1FH-2FM, 169-75;  TWR MN 8HH-2FH-1FM, 169-77;  TWR MN 8HH-2HM-2FM, 169-78;  TWR MN 8HH-2HM-2FM, 138939-01;  TWR MN 8HH-3FF, 169-79;  TWR MN 8HH-3FH, 169-80;  TWR MN 8HH-3FH, 138956-01;  TWR MN 8HH-3FM, 169-81;  TWR MN 8HH-3FM, 138923-01.    BD PYXIS MEDFLEX MN (Name, REF):  1000 12HH, 139055-01;  1000 2HH-2FM, 139041-01;  1000 2HH-5FM, 139046-01;  1000 4HH-4FM, 139049-01;  1000 6HH-3FM, 139051-01;  1000 8HH-2FM, 139052-01;  2000 8HH-2FH, 139165-01;  2000 8HH-2FM, 139069-01.    MEDBANK MAIN, 1137-00;  MEDBANK MINI MAIN, 1147-00;  MEDBANK TOWER MAIN, 1145-00;  MEDFLEX, 1119-00;  MEDFLEX 2.0, 1139-00",
  "description": "FDA recall Z-1639-2025 — CareFusion 303, Inc. is recalling BD PYXIS MEDBANK (Name, REF):  MEDPASS MODULE, 139088-01;  MINI 1FH-1FM, 169-137;  MINI 1HH-1FH-1HM, 169-101;  MINI 1HH-1HM-1FM, 169-102;  MINI 2FH, 138902-01;  MINI 2FH, 169-104;  MINI 2FM, 169-105;  MINI 2HH-1FH, 169-106;  MINI 2HH-1FH, 138908-01;  MINI 2HH-1FM, 169-107;  MINI 2HH-1FM, 138906-01;  MINI 3HH-1FG, 169-110;  MINI 3HH-1FG, 139091-01;  MINI 3HH-1HM, 169-111;  MINI 4HH, 138910-01;  MINI 4HH, 169-112;  MINI 4HM, 169-113;  MINI 4HM, 138915-01;  TWR MN 10HH-1FH-1FM, 169-23;  TWR MN 10HH-2FH, 169-24;  TWR MN 10HH-2FH, 138955-01;  TWR MN 10HH-2FM, 169-25;  TWR MN 10HH-2FM, 138924-01;  TWR MN 12HH-1FF, 169-26;  TWR MN 12HH-1FF, 138960-01;  TWR MN 12HH-1FH, 169-27;  TWR MN 12HH-1FH, 138961-01;  TWR MN 12HH-1FM, 169-28;  TWR MN 12HH-1FM, 138926-01;  TWR MN 14HH, 138927-01;  TWR MN 14HH, 169-29;  TWR MN 1HH-1HM-2FM-4FF, 169-30;  TWR MN 2FH-2HM-4FM, 169-31;  TWR MN 2HH-10HM-1FM, 169-32;  TWR MN 2HH-1FH-5FM, 169-33;  TWR MN 2HH-2FH-4FM, 169-34;  TWR MN 2HH-4FH-2FM, 169-139;  TWR MN 2HH-4HM-4FM, 139125-01;  TWR MN 2HH-6FM, 169-38;  TWR MN 2HH-6FM, 138919-01;  TWR MN 2HH-6HM-3FM, 169-39;  TWR MN 2HH-8HM-2FM, 169-40;  TWR MN 2HM-6FM, 169-41;  TWR MN 3FH-4FM, 169-42;  TWR MN 3FH-4FM, 138933-01;  TWR MN 3FH-8HH MEDPASS, 169-140;  TWR MN 3HH-7HM-2FM, 169-43;  TWR MN 4HH-10HM, 169-44;  TWR MN 4HH-10HM, 138959-01;  TWR MN 4HH-1FH-2HM-3FM, 169-45;  TWR MN 4HH-1FH-4FM, 169-46;  TWR MN 4HH-1FH-4HM-2FM, 169-47;  TWR MN 4HH-2FH-2HM-2FM, 169-49;  TWR MN 4HH-2FH-3FM, 169-50;  TWR MN 4HH-2FH-3FM, 138931-01;  TWR MN 4HH-3FH-2FM, 169-52;  TWR MN 4HH-4FH-1FM, 169-53;  TWR MN 4HH-4FH-1FM, 138940-01;  TWR MN 4HH-4HM-3FM, 169-54;  TWR MN 4HH-4HM-3FM, 138952-01;  TWR MN 4HH-5FH, 169-55;  TWR MN 4HH-5FM, 169-56;  TWR MN 4HH-5FM, 138918-01;  TWR MN 4HH-6HM-2FM, 169-57;  TWR MN 4HM-5FM, 169-59;  TWR MN 5HH-3HM-3FM, 169-60;  TWR MN 5HH-9HM, 138914-01;  TWR MN 5HH-9HM, 169-61;  TWR MN 6FH-1FM, 169-62;  TWR MN 6HH-1FH-2HM-2FM, 169-63;  TWR MN 6HH-1FH-3FM, 169-64;  TWR MN 6HH-2FH-2FM, 169-65;  TWR MN 6HH-4FH, 169-67;  TWR MN 6HH-4FH, 138957-01;  TWR MN 6HH-4FM, 169-68;  TWR MN 6HH-4FM, 138922-01;  TWR MN 6HH-4HM-2FM, 169-69;  TWR MN 6HH-8HM, 169-71;  TWR MN 6HH-8HM, 138958-01;  TWR MN 7FH, 169-72;  TWR MN 7FH, 138920-01;  TWR MN 7FM, 169-73;  TWR MN 7FM, 138937-01;  TWR MN 7HH-1HM-3FM, 139086-01;  TWR MN 7HH-1HM-3FM, 169-74;  TWR MN 8HH-1FH-2FM, 169-75;  TWR MN 8HH-2FH-1FM, 169-77;  TWR MN 8HH-2HM-2FM, 169-78;  TWR MN 8HH-2HM-2FM, 138939-01;  TWR MN 8HH-3FF, 169-79;  TWR MN 8HH-3FH, 169-80;  TWR MN 8HH-3FH, 138956-01;  TWR MN 8HH-3FM, 169-81;  TWR MN 8HH-3FM, 138923-01.    BD PYXIS MEDFLEX MN (Name, REF):  1000 12HH, 139055-01;  1000 2HH-2FM, 139041-01;  1000 2HH-5FM, 139046-01;  1000 4HH-4FM, 139049-01;  1000 6HH-3FM, 139051-01;  1000 8HH-2FM, 139052-01;  2000 8HH-2FH, 139165-01;  2000 8HH-2FM, 139069-01.    MEDBANK MAIN, 1137-00;  MEDBANK MINI MAIN, 1147-00;  MEDBANK TOWER MAIN, 1145-00;  MEDFLEX, 1119-00;  MEDFLEX 2.0, 1139-00 (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-1639-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BD PYXIS MEDBANK (Name, REF):  MEDPASS MODULE, 139088-01;  MINI 1FH-1FM, 169-137;  MINI 1HH-1FH-1HM, 169-101;  MINI 1HH-1HM-1FM, 169-102;  MINI 2FH, 138902-01;  MINI 2FH, 169-104;  MINI 2FM, 169-105;  MINI 2HH-1FH, 169-106;  MINI 2HH-1FH, 138908-01;  MINI 2HH-1FM, 169-107;  MINI 2HH-1FM, 138906-01;  MINI 3HH-1FG, 169-110;  MINI 3HH-1FG, 139091-01;  MINI 3HH-1HM, 169-111;  MINI 4HH, 138910-01;  MINI 4HH, 169-112;  MINI 4HM, 169-113;  MINI 4HM, 138915-01;  TWR MN 10HH-1FH-1FM, 169-23;  TWR MN 10HH-2FH, 169-24;  TWR MN 10HH-2FH, 138955-01;  TWR MN 10HH-2FM, 169-25;  TWR MN 10HH-2FM, 138924-01;  TWR MN 12HH-1FF, 169-26;  TWR MN 12HH-1FF, 138960-01;  TWR MN 12HH-1FH, 169-27;  TWR MN 12HH-1FH, 138961-01;  TWR MN 12HH-1FM, 169-28;  TWR MN 12HH-1FM, 138926-01;  TWR MN 14HH, 138927-01;  TWR MN 14HH, 169-29;  TWR MN 1HH-1HM-2FM-4FF, 169-30;  TWR MN 2FH-2HM-4FM, 169-31;  TWR MN 2HH-10HM-1FM, 169-32;  TWR MN 2HH-1FH-5FM, 169-33;  TWR MN 2HH-2FH-4FM, 169-34;  TWR MN 2HH-4FH-2FM, 169-139;  TWR MN 2HH-4HM-4FM, 139125-01;  TWR MN 2HH-6FM, 169-38;  TWR MN 2HH-6FM, 138919-01;  TWR MN 2HH-6HM-3FM, 169-39;  TWR MN 2HH-8HM-2FM, 169-40;  TWR MN 2HM-6FM, 169-41;  TWR MN 3FH-4FM, 169-42;  TWR MN 3FH-4FM, 138933-01;  TWR MN 3FH-8HH MEDPASS, 169-140;  TWR MN 3HH-7HM-2FM, 169-43;  TWR MN 4HH-10HM, 169-44;  TWR MN 4HH-10HM, 138959-01;  TWR MN 4HH-1FH-2HM-3FM, 169-45;  TWR MN 4HH-1FH-4FM, 169-46;  TWR MN 4HH-1FH-4HM-2FM, 169-47;  TWR MN 4HH-2FH-2HM-2FM, 169-49;  TWR MN 4HH-2FH-3FM, 169-50;  TWR MN 4HH-2FH-3FM, 138931-01;  TWR MN 4HH-3FH-2FM, 169-52;  TWR MN 4HH-4FH-1FM, 169-53;  TWR MN 4HH-4FH-1FM, 138940-01;  TWR MN 4HH-4HM-3FM, 169-54;  TWR MN 4HH-4HM-3FM, 138952-01;  TWR MN 4HH-5FH, 169-55;  TWR MN 4HH-5FM, 169-56;  TWR MN 4HH-5FM, 138918-01;  TWR MN 4HH-6HM-2FM, 169-57;  TWR MN 4HM-5FM, 169-59;  TWR MN 5HH-3HM-3FM, 169-60;  TWR MN 5HH-9HM, 138914-01;  TWR MN 5HH-9HM, 169-61;  TWR MN 6FH-1FM, 169-62;  TWR MN 6HH-1FH-2HM-2FM, 169-63;  TWR MN 6HH-1FH-3FM, 169-64;  TWR MN 6HH-2FH-2FM, 169-65;  TWR MN 6HH-4FH, 169-67;  TWR MN 6HH-4FH, 138957-01;  TWR MN 6HH-4FM, 169-68;  TWR MN 6HH-4FM, 138922-01;  TWR MN 6HH-4HM-2FM, 169-69;  TWR MN 6HH-8HM, 169-71;  TWR MN 6HH-8HM, 138958-01;  TWR MN 7FH, 169-72;  TWR MN 7FH, 138920-01;  TWR MN 7FM, 169-73;  TWR MN 7FM, 138937-01;  TWR MN 7HH-1HM-3FM, 139086-01;  TWR MN 7HH-1HM-3FM, 169-74;  TWR MN 8HH-1FH-2FM, 169-75;  TWR MN 8HH-2FH-1FM, 169-77;  TWR MN 8HH-2HM-2FM, 169-78;  TWR MN 8HH-2HM-2FM, 138939-01;  TWR MN 8HH-3FF, 169-79;  TWR MN 8HH-3FH, 169-80;  TWR MN 8HH-3FH, 138956-01;  TWR MN 8HH-3FM, 169-81;  TWR MN 8HH-3FM, 138923-01.    BD PYXIS MEDFLEX MN (Name, REF):  1000 12HH, 139055-01;  1000 2HH-2FM, 139041-01;  1000 2HH-5FM, 139046-01;  1000 4HH-4FM, 139049-01;  1000 6HH-3FM, 139051-01;  1000 8HH-2FM, 139052-01;  2000 8HH-2FH, 139165-01;  2000 8HH-2FM, 139069-01.    MEDBANK MAIN, 1137-00;  MEDBANK MINI MAIN, 1147-00;  MEDBANK TOWER MAIN, 1145-00;  MEDFLEX, 1119-00;  MEDFLEX 2.0, 1139-00",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "CareFusion 303, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1639-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1639-2025: CareFusion 303, Inc. is recalling BD PYXIS MEDBANK (Name, REF):  MEDPASS MODULE, 139088-01;  MINI 1FH-1FM, 169-137;  MINI 1HH-1FH-1HM, 169-101;  MINI 1HH-1HM-1FM, 169-102;  MINI 2FH, 138902-01;  MINI 2FH, 169-104;  MINI 2FM, 169-105;  MINI 2HH-1FH, 169-106;  MINI 2HH-1FH, 138908-01;  MINI 2HH-1FM, 169-107;  MINI 2HH-1FM, 138906-01;  MINI 3HH-1FG, 169-110;  MINI 3HH-1FG, 139091-01;  MINI 3HH-1HM, 169-111;  MINI 4HH, 138910-01;  MINI 4HH, 169-112;  MINI 4HM, 169-113;  MINI 4HM, 138915-01;  TWR MN 10HH-1FH-1FM, 169-23;  TWR MN 10HH-2FH, 169-24;  TWR MN 10HH-2FH, 138955-01;  TWR MN 10HH-2FM, 169-25;  TWR MN 10HH-2FM, 138924-01;  TWR MN 12HH-1FF, 169-26;  TWR MN 12HH-1FF, 138960-01;  TWR MN 12HH-1FH, 169-27;  TWR MN 12HH-1FH, 138961-01;  TWR MN 12HH-1FM, 169-28;  TWR MN 12HH-1FM, 138926-01;  TWR MN 14HH, 138927-01;  TWR MN 14HH, 169-29;  TWR MN 1HH-1HM-2FM-4FF, 169-30;  TWR MN 2FH-2HM-4FM, 169-31;  TWR MN 2HH-10HM-1FM, 169-32;  TWR MN 2HH-1FH-5FM, 169-33;  TWR MN 2HH-2FH-4FM, 169-34;  TWR MN 2HH-4FH-2FM, 169-139;  TWR MN 2HH-4HM-4FM, 139125-01;  TWR MN 2HH-6FM, 169-38;  TWR MN 2HH-6FM, 138919-01;  TWR MN 2HH-6HM-3FM, 169-39;  TWR MN 2HH-8HM-2FM, 169-40;  TWR MN 2HM-6FM, 169-41;  TWR MN 3FH-4FM, 169-42;  TWR MN 3FH-4FM, 138933-01;  TWR MN 3FH-8HH MEDPASS, 169-140;  TWR MN 3HH-7HM-2FM, 169-43;  TWR MN 4HH-10HM, 169-44;  TWR MN 4HH-10HM, 138959-01;  TWR MN 4HH-1FH-2HM-3FM, 169-45;  TWR MN 4HH-1FH-4FM, 169-46;  TWR MN 4HH-1FH-4HM-2FM, 169-47;  TWR MN 4HH-2FH-2HM-2FM, 169-49;  TWR MN 4HH-2FH-3FM, 169-50;  TWR MN 4HH-2FH-3FM, 138931-01;  TWR MN 4HH-3FH-2FM, 169-52;  TWR MN 4HH-4FH-1FM, 169-53;  TWR MN 4HH-4FH-1FM, 138940-01;  TWR MN 4HH-4HM-3FM, 169-54;  TWR MN 4HH-4HM-3FM, 138952-01;  TWR MN 4HH-5FH, 169-55;  TWR MN 4HH-5FM, 169-56;  TWR MN 4HH-5FM, 138918-01;  TWR MN 4HH-6HM-2FM, 169-57;  TWR MN 4HM-5FM, 169-59;  TWR MN 5HH-3HM-3FM, 169-60;  TWR MN 5HH-9HM, 138914-01;  TWR MN 5HH-9HM, 169-61;  TWR MN 6FH-1FM, 169-62;  TWR MN 6HH-1FH-2HM-2FM, 169-63;  TWR MN 6HH-1FH-3FM, 169-64;  TWR MN 6HH-2FH-2FM, 169-65;  TWR MN 6HH-4FH, 169-67;  TWR MN 6HH-4FH, 138957-01;  TWR MN 6HH-4FM, 169-68;  TWR MN 6HH-4FM, 138922-01;  TWR MN 6HH-4HM-2FM, 169-69;  TWR MN 6HH-8HM, 169-71;  TWR MN 6HH-8HM, 138958-01;  TWR MN 7FH, 169-72;  TWR MN 7FH, 138920-01;  TWR MN 7FM, 169-73;  TWR MN 7FM, 138937-01;  TWR MN 7HH-1HM-3FM, 139086-01;  TWR MN 7HH-1HM-3FM, 169-74;  TWR MN 8HH-1FH-2FM, 169-75;  TWR MN 8HH-2FH-1FM, 169-77;  TWR MN 8HH-2HM-2FM, 169-78;  TWR MN 8HH-2HM-2FM, 138939-01;  TWR MN 8HH-3FF, 169-79;  TWR MN 8HH-3FH, 169-80;  TWR MN 8HH-3FH, 138956-01;  TWR MN 8HH-3FM, 169-81;  TWR MN 8HH-3FM, 138923-01.    BD PYXIS MEDFLEX MN (Name, REF):  1000 12HH, 139055-01;  1000 2HH-2FM, 139041-01;  1000 2HH-5FM, 139046-01;  1000 4HH-4FM, 139049-01;  1000 6HH-3FM, 139051-01;  1000 8HH-2FM, 139052-01;  2000 8HH-2FH, 139165-01;  2000 8HH-2FM, 139069-01.    MEDBANK MAIN, 1137-00;  MEDBANK MINI MAIN, 1147-00;  MEDBANK TOWER MAIN, 1145-00;  MEDFLEX, 1119-00;  MEDFLEX 2.0, 1139-00",
      "text": "The FDA logged enforcement record Z-1639-2025: CareFusion 303, Inc. is voluntarily recalling BD PYXIS MEDBANK (Name, REF):  MEDPASS MODULE, 139088-01;  MINI 1FH-1FM, 169-137;  MINI 1HH-1FH-1HM, 169-101;  MINI 1HH-1HM-1FM, 169-102;  MINI 2FH, 138902-01;  MINI 2FH, 169-104;  MINI 2FM, 169-105;  MINI 2HH-1FH, 169-106;  MINI 2HH-1FH, 138908-01;  MINI 2HH-1FM, 169-107;  MINI 2HH-1FM, 138906-01;  MINI 3HH-1FG, 169-110;  MINI 3HH-1FG, 139091-01;  MINI 3HH-1HM, 169-111;  MINI 4HH, 138910-01;  MINI 4HH, 169-112;  MINI 4HM, 169-113;  MINI 4HM, 138915-01;  TWR MN 10HH-1FH-1FM, 169-23;  TWR MN 10HH-2FH, 169-24;  TWR MN 10HH-2FH, 138955-01;  TWR MN 10HH-2FM, 169-25;  TWR MN 10HH-2FM, 138924-01;  TWR MN 12HH-1FF, 169-26;  TWR MN 12HH-1FF, 138960-01;  TWR MN 12HH-1FH, 169-27;  TWR MN 12HH-1FH, 138961-01;  TWR MN 12HH-1FM, 169-28;  TWR MN 12HH-1FM, 138926-01;  TWR MN 14HH, 138927-01;  TWR MN 14HH, 169-29;  TWR MN 1HH-1HM-2FM-4FF, 169-30;  TWR MN 2FH-2HM-4FM, 169-31;  TWR MN 2HH-10HM-1FM, 169-32;  TWR MN 2HH-1FH-5FM, 169-33;  TWR MN 2HH-2FH-4FM, 169-34;  TWR MN 2HH-4FH-2FM, 169-139;  TWR MN 2HH-4HM-4FM, 139125-01;  TWR MN 2HH-6FM, 169-38;  TWR MN 2HH-6FM, 138919-01;  TWR MN 2HH-6HM-3FM, 169-39;  TWR MN 2HH-8HM-2FM, 169-40;  TWR MN 2HM-6FM, 169-41;  TWR MN 3FH-4FM, 169-42;  TWR MN 3FH-4FM, 138933-01;  TWR MN 3FH-8HH MEDPASS, 169-140;  TWR MN 3HH-7HM-2FM, 169-43;  TWR MN 4HH-10HM, 169-44;  TWR MN 4HH-10HM, 138959-01;  TWR MN 4HH-1FH-2HM-3FM, 169-45;  TWR MN 4HH-1FH-4FM, 169-46;  TWR MN 4HH-1FH-4HM-2FM, 169-47;  TWR MN 4HH-2FH-2HM-2FM, 169-49;  TWR MN 4HH-2FH-3FM, 169-50;  TWR MN 4HH-2FH-3FM, 138931-01;  TWR MN 4HH-3FH-2FM, 169-52;  TWR MN 4HH-4FH-1FM, 169-53;  TWR MN 4HH-4FH-1FM, 138940-01;  TWR MN 4HH-4HM-3FM, 169-54;  TWR MN 4HH-4HM-3FM, 138952-01;  TWR MN 4HH-5FH, 169-55;  TWR MN 4HH-5FM, 169-56;  TWR MN 4HH-5FM, 138918-01;  TWR MN 4HH-6HM-2FM, 169-57;  TWR MN 4HM-5FM, 169-59;  TWR MN 5HH-3HM-3FM, 169-60;  TWR MN 5HH-9HM, 138914-01;  TWR MN 5HH-9HM, 169-61;  TWR MN 6FH-1FM, 169-62;  TWR MN 6HH-1FH-2HM-2FM, 169-63;  TWR MN 6HH-1FH-3FM, 169-64;  TWR MN 6HH-2FH-2FM, 169-65;  TWR MN 6HH-4FH, 169-67;  TWR MN 6HH-4FH, 138957-01;  TWR MN 6HH-4FM, 169-68;  TWR MN 6HH-4FM, 138922-01;  TWR MN 6HH-4HM-2FM, 169-69;  TWR MN 6HH-8HM, 169-71;  TWR MN 6HH-8HM, 138958-01;  TWR MN 7FH, 169-72;  TWR MN 7FH, 138920-01;  TWR MN 7FM, 169-73;  TWR MN 7FM, 138937-01;  TWR MN 7HH-1HM-3FM, 139086-01;  TWR MN 7HH-1HM-3FM, 169-74;  TWR MN 8HH-1FH-2FM, 169-75;  TWR MN 8HH-2FH-1FM, 169-77;  TWR MN 8HH-2HM-2FM, 169-78;  TWR MN 8HH-2HM-2FM, 138939-01;  TWR MN 8HH-3FF, 169-79;  TWR MN 8HH-3FH, 169-80;  TWR MN 8HH-3FH, 138956-01;  TWR MN 8HH-3FM, 169-81;  TWR MN 8HH-3FM, 138923-01.    BD PYXIS MEDFLEX MN (Name, REF):  1000 12HH, 139055-01;  1000 2HH-2FM, 139041-01;  1000 2HH-5FM, 139046-01;  1000 4HH-4FM, 139049-01;  1000 6HH-3FM, 139051-01;  1000 8HH-2FM, 139052-01;  2000 8HH-2FH, 139165-01;  2000 8HH-2FM, 139069-01.    MEDBANK MAIN, 1137-00;  MEDBANK MINI MAIN, 1147-00;  MEDBANK TOWER MAIN, 1145-00;  MEDFLEX, 1119-00;  MEDFLEX 2.0, 1139-00 — reason: Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-11. Affected lots/codes: REF/UDI-DI(GTIN)/Software Version: 139088-01/1.2.3.23; 169-137/10885403512544/2.4; 169-101/10885403512544/2.4; 169-102/10885403512544/2.4; 138902-01/2.4; 169-104/10885403512544/2.4; 169-105/10885403512544/2.4; 169-106/10885403512544/2.4; 138908-01/2.4; 169-107/10885403512544/2.4; 138906-01/2.4; 169-108/10885403512544/2.4; 169-110/10885403512544/2.4; 139091-01/2.4; 169-111/10885403512544/2.4; 138910-01/2.4; 169-112/10885403512544/2.4; 169-113/10885403512544/2.4; 138915-01/2.4; 169-23/10885403512568/2.4; 169-24/10885403512568/2.4; 138955-01/2.4; 169-25/10885403512568/2.4; 138924-01/2.4; 169-26/10885403512568/2.4; 138960-01/2.4; 169-27/10885403512568/2.4; 138961-01/2.4; 169-28/10885403512568/2.4; 138926-01/2.4; 138927-01/2.4; 169-29/10885403512568/2.4; 169-30/10885403512568/2.4; 169-31/10885403512568/2.4; 169-32/10885403512568/2.4; 169-33/10885403512568/2.4; 169-34/10885403512568/2.4; 169-139/10885403512568/2.4; 139125-01/2.4; 169-38/10885403512568/2.4; 138919-01/2.4; 169-39/10885403512568/2.4; 169-40/10885403512568/2.4; 169-41/10885403512568/2.4; 169-42/10885403512568/2.4; 138933-01/2.4; 169-140/10885403512568/1.2.3.23; 169-43/10885403512568/2.4; 169-44/10885403512568/2.4; 138959-01/2.4; 169-45/10885403512568/2.4; 169-46/10885403512568/2.4; 169-47/10885403512568/2.4; 169-49/10885403512568/2.4; 169-50/10885403512568/2.4; 138931-01/2.4; 169-52/10885403512568/2.4; 169-53/10885403512568/2.4; 138940-01/2.4; 169-54/10885403512568/2.4; 138952-01/2.4; 169-55/10885403512568/2.4; 169-56/10885403512568/2.4; 138918-01/2.4; 169-57/10885403512568/2.4; 169-59/10885403512568/2.4; 169-60/10885403512568/2.4; 138914-01/2.4; 169-61/10885403512568/2.4; 169-62/10885403512568/2.4; 169-63/10885403512568/2.4; 169-64/10885403512568/2.4; 169-65/10885403512568/2.4; 169-67/10885403512568/2.4; 138957-01/2.4; 169-68/10885403512568/2.4; 138922-01/2.4; 169-69/10885403512568/2.4; 169-71/10885403512568/2.4; 138958-01/2.4; 169-72/10885403512568/2.4; 138920-01/2.4; 169-73/10885403512568/2.4; 138937-01/2.4; 139086-01/2.4; 169-74/10885403512568/2.4; 169-75/10885403512568/2.4; 169-77/10885403512568/2.4; 169-78/10885403512568/2.4; 138939-01/2.4; 169-79/10885403512568/2.4; 169-80/10885403512568/2.4; 138956-01/2.4; 169-81/10885403512568/2.4; 138923-01/2.4;  139055-01/2.4; 139041-01/2.4; 139046-01/2.4; 139049-01/2.4; 139051-01/2.4; 139052-01/2.4; 139165-01/2.4; 139069-01/2.4;  1137-00/2.4; 1147-00/10885403517181/2.4; 1145-00/10885403517167/2.4; 1119-00/10885403512704/2.4; 1139-00/10885403512704/2.4. 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-1639-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1639-2025&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1639-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1639-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1639-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1639-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1639-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1639-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1639-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "CareFusion 303, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-03-11",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "REF/UDI-DI(GTIN)/Software Version: 139088-01/1.2.3.23; 169-137/10885403512544/2.4; 169-101/10885403512544/2.4; 169-102/10885403512544/2.4; 138902-01/2.4; 169-104/10885403512544/2.4; 169-105/10885403512544/2.4; 169-106/10885403512544/2.4; 138908-01/2.4; 169-107/10885403512544/2.4; 138906-01/2.4; 169-108/10885403512544/2.4; 169-110/10885403512544/2.4; 139091-01/2.4; 169-111/10885403512544/2.4; 138910-01/2.4; 169-112/10885403512544/2.4; 169-113/10885403512544/2.4; 138915-01/2.4; 169-23/10885403512568/2.4; 169-24/10885403512568/2.4; 138955-01/2.4; 169-25/10885403512568/2.4; 138924-01/2.4; 169-26/10885403512568/2.4; 138960-01/2.4; 169-27/10885403512568/2.4; 138961-01/2.4; 169-28/10885403512568/2.4; 138926-01/2.4; 138927-01/2.4; 169-29/10885403512568/2.4; 169-30/10885403512568/2.4; 169-31/10885403512568/2.4; 169-32/10885403512568/2.4; 169-33/10885403512568/2.4; 169-34/10885403512568/2.4; 169-139/10885403512568/2.4; 139125-01/2.4; 169-38/10885403512568/2.4; 138919-01/2.4; 169-39/10885403512568/2.4; 169-40/10885403512568/2.4; 169-41/10885403512568/2.4; 169-42/10885403512568/2.4; 138933-01/2.4; 169-140/10885403512568/1.2.3.23; 169-43/10885403512568/2.4; 169-44/10885403512568/2.4; 138959-01/2.4; 169-45/10885403512568/2.4; 169-46/10885403512568/2.4; 169-47/10885403512568/2.4; 169-49/10885403512568/2.4; 169-50/10885403512568/2.4; 138931-01/2.4; 169-52/10885403512568/2.4; 169-53/10885403512568/2.4; 138940-01/2.4; 169-54/10885403512568/2.4; 138952-01/2.4; 169-55/10885403512568/2.4; 169-56/10885403512568/2.4; 138918-01/2.4; 169-57/10885403512568/2.4; 169-59/10885403512568/2.4; 169-60/10885403512568/2.4; 138914-01/2.4; 169-61/10885403512568/2.4; 169-62/10885403512568/2.4; 169-63/10885403512568/2.4; 169-64/10885403512568/2.4; 169-65/10885403512568/2.4; 169-67/10885403512568/2.4; 138957-01/2.4; 169-68/10885403512568/2.4; 138922-01/2.4; 169-69/10885403512568/2.4; 169-71/10885403512568/2.4; 138958-01/2.4; 169-72/10885403512568/2.4; 138920-01/2.4; 169-73/10885403512568/2.4; 138937-01/2.4; 139086-01/2.4; 169-74/10885403512568/2.4; 169-75/10885403512568/2.4; 169-77/10885403512568/2.4; 169-78/10885403512568/2.4; 138939-01/2.4; 169-79/10885403512568/2.4; 169-80/10885403512568/2.4; 138956-01/2.4; 169-81/10885403512568/2.4; 138923-01/2.4;  139055-01/2.4; 139041-01/2.4; 139046-01/2.4; 139049-01/2.4; 139051-01/2.4; 139052-01/2.4; 139165-01/2.4; 139069-01/2.4;  1137-00/2.4; 1147-00/10885403517181/2.4; 1145-00/10885403517167/2.4; 1119-00/10885403512704/2.4; 1139-00/10885403512704/2.4",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution including in the states of MO, MI, FL, PA, SC, OR, AZ, CO, ND, GA, NE, TX, IL, OH, VT, IN, TN, KY, IA, MT, NY, CA, UT, OK, SD, WA, AK, ME, NV, NM, NC, WV, LA, MN, ID, AL, VA, WI, NH, KS, MA, CT, RI, NJ, MD, MS, WY, DC, DE, HI, AR, ON.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}