BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
type: Dataset
description: FDA recall Z-0671-2025 — CareFusion 303, Inc. is recalling BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 (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/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-0671-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
claims: FDA classified recall Z-0671-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0671-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0671-2025
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: CareFusion 303, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-11-14
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: All software versions. REF/UDI-DI: 324/10885403512681/ 12440840 12440841 12448208 12452252 12452264 12455476 12462734 12462735 12463676 12468609 12468612 12468607 12468608 12468610 12468671 12468672 12468674 12468670 12468673 12468611 12474015 12474022 12473810 12473813 12473815 12473816 12473817 12473811 12473921 12474012 12474071 12474014 12473887 12473922 12474013 12473807 12473812 12473808 12473809 12476548 12495456 12499285 12502858 12502857 12503069 12508589 12508584 12508578 12508579 12508587 12508580 12510555 12510559 12510393 12520264 12520266 12520267 12520269 12528519 12528411 12530586 12530588 12530589 12530587 12531133 12531132 12532495 12532494 12532490 12532491 12532493 12532492 12533583 12533588 12533589 12533562 12533563 12533561 12533584 12533587 12533585 12533586 12533259 12533261 12533262 12533263 12534455 12534456 12534461 12540265 12540264 12544944 12546962 12547840 12547841 12549213 12552380 12552381 12553970 12553971 12553972 12553973 12553558 12553773 12553559 12553974 12553766 12553767 12553774 12555796 12555818 12555808 12555807 12563092 12563091 12563094 12564425 12568586 12568682 12572289 12572290 12572295 12572296 12572301 12572304 12572294 12572306 12572308 12572297 12572298 12572292 12572299 12572300 12572305 12572302 12572307 12572904 12572907 12572908 12572900 12572901 12572902 12572905 12572906 12572903 12575531 12579325 12582556 12582557 12583764 12583765 12583766 12583762 12583767 12583769 12583770 12583761 12583768 12583771 12586361 12588457 12588462 12588460 12588475 12588658 12588657 12588466 12588467 12589599 12589594 12589602 12589597 12589601 12589603 12589604 12589679 12589655 12589654 12589915 12591607 12591608 12591604 12591609 12591605 12591606 12592584 12593277 12593278 12593881 12593841 12593842 12594535 12594534 12595267 12596860 12596873 12596861 12598571 12598573 12598572 12599172 12599173 12599175 12599171 12599176 12599177 12600360 12600361 12599975 12600650 12600801 12600800 12600804 12600805 12600803 12604313 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.
      status: recorded

FDA recall Z-0671-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
type: Claim
text: The FDA logged enforcement record Z-0671-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 — reason: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-14. Affected lots/codes: All software versions. REF/UDI-DI: 324/10885403512681/ 12440840 12440841 12448208 12452252 12452264 12455476 12462734 12462735 12463676 12468609 12468612 12468607 12468608 12468610 12468671 12468672 12468674 12468670 12468673 12468611 12474015 12474022 12473810 12473813 12473815 12473816 12473817 12473811 12473921 12474012 12474071 12474014 12473887 12473922 12474013 12473807 12473812 12473808 12473809 12476548 12495456 12499285 12502858 12502857 12503069 12508589 12508584 12508578 12508579 12508587 12508580 12510555 12510559 12510393 12520264 12520266 12520267 12520269 12528519 12528411 12530586 12530588 12530589 12530587 12531133 12531132 12532495 12532494 12532490 12532491 12532493 12532492 12533583 12533588 12533589 12533562 12533563 12533561 12533584 12533587 12533585 12533586 12533259 12533261 12533262 12533263 12534455 12534456 12534461 12540265 12540264 12544944 12546962 12547840 12547841 12549213 12552380 12552381 12553970 12553971 12553972 12553973 12553558 12553773 12553559 12553974 12553766 12553767 12553774 12555796 12555818 12555808 12555807 12563092 12563091 12563094 12564425 12568586 12568682 12572289 12572290 12572295 12572296 12572301 12572304 12572294 12572306 12572308 12572297 12572298 12572292 12572299 12572300 12572305 12572302 12572307 12572904 12572907 12572908 12572900 12572901 12572902 12572905 12572906 12572903 12575531 12579325 12582556 12582557 12583764 1258…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
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.

FDA classified recall Z-0671-2025 as Class II
type: Claim
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.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
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.

What an FDA recall is — and is NOT
type: Claim
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.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
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.