BD Pyxis MedStation ES (Med ES Main), REF 323
type: Dataset
description: FDA recall Z-0971-2025 — CareFusion 303, Inc. is recalling BD Pyxis MedStation ES (Med ES Main), REF 323 (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 (Med ES Main), REF 323
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-0971-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation ES (Med ES Main), REF 323
claims: FDA classified recall Z-0971-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0971-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0971-2025
      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 10885403212667, Serial Numbers: 12439897, 12440725, 12440974, 12440975, 12441103, 12441333, 12441432, 12447684, 12451247, 12451619, 12455492, 12455493, 12455498, 12455793, 12456970, 12463612, 12469470, 12469471, 12469488, 12470842, 12474026, 12476547, 12483201, 12483203, 12483393, 12483402, 12486737, 12499043, 12499616, 12499617, 12499618, 12499838, 12501936, 12502072, 12502073, 12502074, 12502075, 12502076, 12502077, 12502078, 12502079, 12502080, 12504784, 12505982, 12507257, 12507258, 12507411, 12508303, 12510196, 12511166, 12511167, 12511168, 12511169, 12511170, 12511171, 12511172, 12511173, 12511174, 12511933, 12511934, 12511935, 12514265, 12514266, 12514267, 12515355, 12515356, 12515357, 12515358, 12515360, 12515364, 12515366, 12519098, 12522942, 12524481, 12527930, 12528709, 12528710, 12530090, 12531297, 12531298, 12531352, 12531353, 12531354, 12531414, 12531415, 12531416, 12531417, 12531418, 12531420, 12531421, 12531422, 12531423, 12540194, 12540196, 12540267, 12540268, 12540269, 12546326, 12546755, 12554583, 12561139, 12568697, 12569170, 12570745, 12570746, 12570748, 12570749, 12570750, 12570753, 12580842, 12582687, 12585183, 12585184, 12587302, 12587564, 12588421, 12589618, 12589657, 12589658, 12589659, 12589685, 12590119, 12590956, 12591330, 12593259, 12593827, 12593828, 12593829, 12593882, 12594025, 12595326, 12596404, 12597474, 12597475, 12597477, 12597478, 12597479, 12597489, 12597491, 12597492, 12597493, 12598838, 12599061, 12599062, 12599063, 12599064, 12599065, 12599066, 12599067, 12599069, 12599070, 12599135, 12599136, 12599137, 12599138, 12599139, 12599140, 12599141, 12599570, 12599571, 12599970, 12599971, 12600268, 12600435, 12600467, 12600468, 12600469, 12600687, 12600689, 12600690, 12600691, 12600880, 12602140, 12602357, 12602358, 12602359, 12602360, 12602361, 12602372, 12602374, 12602731, 12603750, 12603751, 12603752, 12603758, 12603759, 12603760, 12605893, 12605985, 12606524, 12608139, 12608631, 12611808, 12611816, 12611926, 12612390, 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0971-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation ES (Med ES Main), REF 323
type: Claim
text: The FDA logged enforcement record Z-0971-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis MedStation ES (Med ES Main), REF 323 — 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 10885403212667, Serial Numbers: 12439897, 12440725, 12440974, 12440975, 12441103, 12441333, 12441432, 12447684, 12451247, 12451619, 12455492, 12455493, 12455498, 12455793, 12456970, 12463612, 12469470, 12469471, 12469488, 12470842, 12474026, 12476547, 12483201, 12483203, 12483393, 12483402, 12486737, 12499043, 12499616, 12499617, 12499618, 12499838, 12501936, 12502072, 12502073, 12502074, 12502075, 12502076, 12502077, 12502078, 12502079, 12502080, 12504784, 12505982, 12507257, 12507258, 12507411, 12508303, 12510196, 12511166, 12511167, 12511168, 12511169, 12511170, 12511171, 12511172, 12511173, 12511174, 12511933, 12511934, 12511935, 12514265, 12514266, 12514267, 12515355, 12515356, 12515357, 12515358, 12515360, 12515364, 12515366, 12519098, 12522942, 12524481, 12527930, 12528709, 12528710, 12530090, 12531297, 12531298, 12531352, 12531353, 12531354, 12531414, 12531415, 12531416, 12531417, 12531418, 12531420, 12531421, 12531422, 12531423, 12540194, 12540196, 12540267, 12540268, 12540269, 12546326, 12546755, 12554583, 12561139, 12568697, 12569170, 12570745, 12570746, 12570748, 12570749, 12570750, 12570753, 12580842, 12582687, 12585183, 12585184, 12587302, 12587564, 12588421, 12589618, 12589657, 12589658, 12589659, 12589685, 12590119, 12590956, 12591330, 12593259, 12593827, 12593828, 12593829, 12593882, 12594025, 12595326, 12596404, 12597474, 12597475, 12597477, 12597478, 12597479, 12597489, 12597491, 12597492, 12597493, 12598838, 12599061, 1…
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-0971-2025 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.