BD Pyxis MedStation ES AUX, REF 324
type: Dataset
description: FDA recall Z-0972-2025 — CareFusion 303, Inc. is recalling BD Pyxis MedStation ES AUX, 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 AUX, REF 324
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-0972-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation ES AUX, REF 324
claims: FDA classified recall Z-0972-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0972-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0972-2025
      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: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-02-14
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI/DI 10885403512681, Serial Numbers: 9418071, 9418110, 9418124, 9525533, 9525534, 9525559, 9525563, 9525583, 9525601, 9525603, 9525604, 9525607, 9525614, 9525615, 9525616, 9525617, 9525618, 9525629, 9526868, 9528856, 9528857, 9528924, 9528931, 9529144, 9529535, 9530924, 9531251, 9531255, 9531258, 9632432, 9632438, 9632452, 12440840, 12440841, 12448207, 12448208, 12452252, 12452264, 12455476, 12457600, 12457601, 12462734, 12462735, 12463676, 12468607, 12468608, 12468609, 12468610, 12468611, 12468612, 12468670, 12468671, 12468672, 12468673, 12468674, 12473807, 12473808, 12473809, 12473810, 12473811, 12473812, 12473813, 12473815, 12473816, 12473817, 12473887, 12473921, 12473922, 12474012, 12474013, 12474014, 12474015, 12474022, 12474071, 12476548, 12483261, 12483264, 12495456, 12498513, 12498514, 12499285, 12502857, 12502858, 12503069, 12507269, 12507270, 12510393, 12510555, 12510559, 12512134, 12520264, 12520266, 12520267, 12520269, 12528411, 12528519, 12530586, 12530587, 12530588, 12530589, 12531132, 12531133, 12532490, 12532491, 12532492, 12532493, 12532494, 12532495, 12533258, 12533259, 12533261, 12533262, 12533263, 12533561, 12533562, 12533563, 12533583, 12533584, 12533585, 12533586, 12533587, 12533588, 12533589, 12534455, 12534456, 12534461, 12540264, 12540265, 12544944, 12546962, 12547840, 12547841, 12549213, 12550872, 12552380, 12552381, 12553558, 12553559, 12553766, 12553767, 12553773, 12553774, 12553970, 12553971, 12553972, 12553973, 12553974, 12555796, 12555807, 12555808, 12555818, 12563091, 12563092, 12563094, 12564425, 12568586, 12568682, 12575531, 12579325, 12582556, 12582557, 12583748, 12583761, 12583762, 12583764, 12583765, 12583766, 12583767, 12583768, 12583769, 12583770, 12583771, 12584202, 12585511, 12586361, 12586431, 12588457, 12588460, 12588462, 12588466, 12588467, 12588475, 12588657, 12588658, 12589594, 12589597, 12589599, 12589601, 12589602, 12589603, 12589604, 12589654, 12589655, 12589679, 12589915, 12591321, 12591604, 12591605, 12591606, 125…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0972-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation ES AUX, REF 324
type: Claim
text: The FDA logged enforcement record Z-0972-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis MedStation ES AUX, REF 324 — reason: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-14. Affected lots/codes: UDI/DI 10885403512681, Serial Numbers: 9418071, 9418110, 9418124, 9525533, 9525534, 9525559, 9525563, 9525583, 9525601, 9525603, 9525604, 9525607, 9525614, 9525615, 9525616, 9525617, 9525618, 9525629, 9526868, 9528856, 9528857, 9528924, 9528931, 9529144, 9529535, 9530924, 9531251, 9531255, 9531258, 9632432, 9632438, 9632452, 12440840, 12440841, 12448207, 12448208, 12452252, 12452264, 12455476, 12457600, 12457601, 12462734, 12462735, 12463676, 12468607, 12468608, 12468609, 12468610, 12468611, 12468612, 12468670, 12468671, 12468672, 12468673, 12468674, 12473807, 12473808, 12473809, 12473810, 12473811, 12473812, 12473813, 12473815, 12473816, 12473817, 12473887, 12473921, 12473922, 12474012, 12474013, 12474014, 12474015, 12474022, 12474071, 12476548, 12483261, 12483264, 12495456, 12498513, 12498514, 12499285, 12502857, 12502858, 12503069, 12507269, 12507270, 12510393, 12510555, 12510559, 12512134, 12520264, 12520266, 12520267, 12520269, 12528411, 12528519, 12530586, 12530587, 12530588, 12530589, 12531132, 12531133, 12532490, 12532491, 12532492, 12532493, 12532494, 12532495, 12533258, 12533259, 12533261, 12533262, 12533263, 12533561, 12533562, 12533563, 12533583, 12533584, 12533585, 12533586, 12533587, 12533588, 12533589, 12534455, 12534456, 12534461, 12540264, 12540265, 12544944, 12546962, 12547840, 12547841, 12549213, 12550872, 12552380, 12552381, 12553558, 12553559, 12553766, 12553767, 12553773, 12553774, 12553970, 12553971, 12553972, 12553973, 12553974, 125…
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-0972-2025 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.