BD Pyxis MedStation 4000 AUX, REF 306
type: Dataset
description: FDA recall Z-0974-2025 — CareFusion 303, Inc. is recalling BD Pyxis MedStation 4000 AUX, REF 306 (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 4000 AUX, REF 306
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-0974-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation 4000 AUX, REF 306
claims: FDA classified recall Z-0974-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0974-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0974-2025
      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 10885403512636, Serial Numbers: 9304700, 9305723, 9309302, 9413001, 9413014, 9415602, 9415665, 9417311, 9417312, 9417335, 9417340, 9417428, 9417430, 9417433, 9417437, 9418065, 9418068, 9418100, 9418105, 9418111, 9418112, 9418113, 9418114, 9418115, 9418129, 9418568, 9523679, 9525535, 9525558, 9525560, 9525561, 9525562, 9525582, 9525590, 9525600, 9525605, 9525606, 9525613, 9525624, 9525630, 9525638, 9525656, 9525657, 9526867, 9528530, 9528836, 9528859, 9528890, 9531253, 9531257, 12439518, 12439520, 12439521, 12439907, 12440208, 12440217, 12440218, 12440219, 12440220, 12440227, 12440339, 12440984, 12440985, 12443922, 12443923, 12445433, 12447385, 12447387, 12447388, 12447389, 12447394, 12447395, 12447396, 12448203, 12448204, 12452249, 12452265, 12452646, 12452649, 12453000, 12453215, 12453217, 12453238, 12453242, 12460386, 12460388, 12461366, 12461367, 12461927, 12462829, 12462831, 12462833, 12462835, 12463516, 12463517, 12463518, 12464145, 12464146, 12465451, 12465452, 12465453, 12465454, 12465455, 12465456, 12465457, 12465458, 12465459, 12466105, 12466106, 12470354, 12470398, 12470399, 12470890, 12472293, 12474035, 12474844, 12474845, 12476540, 12476541, 12476694, 12482559, 12482560, 12482561, 12482562, 12487398, 12487399, 12487400, 12487401, 12487402, 12487403, 12487404, 12487405, 12487407, 12488733, 12488734, 12490126, 12490127, 12494564, 12494565, 12494769, 12494770, 12494771, 12495340, 12495341, 12495344, 12495345, 12498244, 12498247, 12500586, 12500587, 12500588, 12500589, 12500591, 12502193, 12502865, 12502887, 12507268, 12507287, 12507288, 12511509, 12511516, 12511936, 12511937, 12512135, 12515208, 12515688, 12517918, 12517919, 12517922, 12517929, 12517932, 12517940, 12524687, 12525675, 12530269, 12536035, 12539925, 12549048, 12549049, 12549050, 12549064, 12549093, 12549212, 12550827, 12550828, 12553557, 12555134, 12561011, 12561891, 12564119, 12567515, 12568591, 12570581, 12570583, 12570585, 12570588, 12570591, 12571514, 12571516, 12573404, 12573411, 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0974-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation 4000 AUX, REF 306
type: Claim
text: The FDA logged enforcement record Z-0974-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis MedStation 4000 AUX, REF 306 — 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 10885403512636, Serial Numbers: 9304700, 9305723, 9309302, 9413001, 9413014, 9415602, 9415665, 9417311, 9417312, 9417335, 9417340, 9417428, 9417430, 9417433, 9417437, 9418065, 9418068, 9418100, 9418105, 9418111, 9418112, 9418113, 9418114, 9418115, 9418129, 9418568, 9523679, 9525535, 9525558, 9525560, 9525561, 9525562, 9525582, 9525590, 9525600, 9525605, 9525606, 9525613, 9525624, 9525630, 9525638, 9525656, 9525657, 9526867, 9528530, 9528836, 9528859, 9528890, 9531253, 9531257, 12439518, 12439520, 12439521, 12439907, 12440208, 12440217, 12440218, 12440219, 12440220, 12440227, 12440339, 12440984, 12440985, 12443922, 12443923, 12445433, 12447385, 12447387, 12447388, 12447389, 12447394, 12447395, 12447396, 12448203, 12448204, 12452249, 12452265, 12452646, 12452649, 12453000, 12453215, 12453217, 12453238, 12453242, 12460386, 12460388, 12461366, 12461367, 12461927, 12462829, 12462831, 12462833, 12462835, 12463516, 12463517, 12463518, 12464145, 12464146, 12465451, 12465452, 12465453, 12465454, 12465455, 12465456, 12465457, 12465458, 12465459, 12466105, 12466106, 12470354, 12470398, 12470399, 12470890, 12472293, 12474035, 12474844, 12474845, 12476540, 12476541, 12476694, 12482559, 12482560, 12482561, 12482562, 12487398, 12487399, 12487400, 12487401, 12487402, 12487403, 12487404, 12487405, 12487407, 12488733, 12488734, 12490126, 12490127, 12494564, 12494565, 12494769, 12494770, 12494771, 12495340, 12495341, 12495344, 12495345, 12498244, 12498247, 12500586,…
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-0974-2025 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.