BD Pyxis MedStation 4000 Main, REF 303
type: Dataset
description: FDA recall Z-0973-2025 — CareFusion 303, Inc. is recalling BD Pyxis MedStation 4000 Main, REF 303 (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 Main, REF 303
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-0973-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation 4000 Main, REF 303
claims: FDA classified recall Z-0973-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0973-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0973-2025
      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 10885403512629, Serial Numbers: 12439536, 12439538, 12439539, 12439540, 12439541, 12439544, 12440786, 12440787, 12440788, 12440789, 12440790, 12440791, 12440792, 12440978, 12440979, 12441431, 12443165, 12446066, 12448071, 12448072, 12448073, 12448074, 12448142, 12450907, 12450908, 12450909, 12450910, 12450911, 12450912, 12450913, 12450914, 12450915, 12450968, 12450970, 12450971, 12450973, 12450974, 12450975, 12450976, 12451251, 12451628, 12452651, 12452991, 12452993, 12453011, 12453012, 12453013, 12455427, 12455859, 12457587, 12457588, 12457589, 12457590, 12459775, 12461364, 12461365, 12461368, 12461369, 12461516, 12461517, 12461518, 12461520, 12462977, 12462978, 12463388, 12465197, 12465198, 12465199, 12465200, 12466882, 12468231, 12468628, 12470401, 12470403, 12470405, 12470879, 12471080, 12471091, 12471093, 12471094, 12471098, 12471103, 12472362, 12472380, 12472381, 12477309, 12477310, 12477311, 12477771, 12478580, 12479700, 12479701, 12479702, 12479703, 12479722, 12479731, 12482511, 12482801, 12483638, 12483643, 12483646, 12483648, 12483660, 12486734, 12488762, 12488780, 12491135, 12491749, 12491750, 12491835, 12494652, 12494766, 12494767, 12494768, 12494860, 12496186, 12496187, 12496188, 12496189, 12497262, 12497801, 12497802, 12498069, 12498071, 12498072, 12498074, 12498079, 12498080, 12498914, 12499141, 12499287, 12499621, 12499672, 12501188, 12501906, 12501907, 12501910, 12501913, 12502133, 12502134, 12502135, 12502851, 12502853, 12502888, 12507216, 12507380, 12507654, 12508037, 12508038, 12508039, 12508040, 12508041, 12508042, 12510186, 12510407, 12510411, 12511176, 12511178, 12511180, 12511968, 12511969, 12512191, 12512192, 12512193, 12512667, 12512670, 12512671, 12512672, 12512673, 12512674, 12512676, 12514476, 12516647, 12516681, 12516682, 12516683, 12516684, 12517181, 12517182, 12517183, 12517184, 12517264, 12517267, 12517270, 12517599, 12518125, 12518217, 12519001, 12519103, 12520362, 12520895, 12524890, 12524891, 12524892, 12524893, 12524894, 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0973-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation 4000 Main, REF 303
type: Claim
text: The FDA logged enforcement record Z-0973-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis MedStation 4000 Main, REF 303 — 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 10885403512629, Serial Numbers: 12439536, 12439538, 12439539, 12439540, 12439541, 12439544, 12440786, 12440787, 12440788, 12440789, 12440790, 12440791, 12440792, 12440978, 12440979, 12441431, 12443165, 12446066, 12448071, 12448072, 12448073, 12448074, 12448142, 12450907, 12450908, 12450909, 12450910, 12450911, 12450912, 12450913, 12450914, 12450915, 12450968, 12450970, 12450971, 12450973, 12450974, 12450975, 12450976, 12451251, 12451628, 12452651, 12452991, 12452993, 12453011, 12453012, 12453013, 12455427, 12455859, 12457587, 12457588, 12457589, 12457590, 12459775, 12461364, 12461365, 12461368, 12461369, 12461516, 12461517, 12461518, 12461520, 12462977, 12462978, 12463388, 12465197, 12465198, 12465199, 12465200, 12466882, 12468231, 12468628, 12470401, 12470403, 12470405, 12470879, 12471080, 12471091, 12471093, 12471094, 12471098, 12471103, 12472362, 12472380, 12472381, 12477309, 12477310, 12477311, 12477771, 12478580, 12479700, 12479701, 12479702, 12479703, 12479722, 12479731, 12482511, 12482801, 12483638, 12483643, 12483646, 12483648, 12483660, 12486734, 12488762, 12488780, 12491135, 12491749, 12491750, 12491835, 12494652, 12494766, 12494767, 12494768, 12494860, 12496186, 12496187, 12496188, 12496189, 12497262, 12497801, 12497802, 12498069, 12498071, 12498072, 12498074, 12498079, 12498080, 12498914, 12499141, 12499287, 12499621, 12499672, 12501188, 12501906, 12501907, 12501910, 12501913, 12502133, 12502134, 12502135, 12502851, 12502853, 12502888…
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-0973-2025 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.