BD Pyxis" Anesthesia Station ES, REF: 327
type: Dataset
description: FDA recall Z-1931-2024 — CareFusion 303, Inc. is recalling BD Pyxis" Anesthesia Station ES, REF: 327 (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" Anesthesia Station ES, REF: 327
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-1931-2024: CareFusion 303, Inc. is recalling BD Pyxis" Anesthesia Station ES, REF: 327
claims: FDA classified recall Z-1931-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1931-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1931-2024
      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: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-04-15
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI: 10885403512636/Serial numbers added 8/27/2025: 15662739 15662740 15662741 15662743 15662745 15662746 15662747 15662749 15662752 15662753 15662754 15662756 15662758 15662759 15662760 15662761 15662762 15662763 15662764 15662765 15662767 15662768 15662769 15662770 15662771 15662772 15662773 15662774 15662775 15375059 15757979 15757980 15755213 15755214 15755215 15755216 15755217 15755218 15022893 15022894 15022895 15022896 14284496 14284498 17700227 17414413 17276726 17215411 15689985 15689986 15566064 15566065 15566067 15566068 15566069 15566070 15566071 15566072 15566073 15566074 15566075 15566076 15566077 15566078 15566079 15540267 15540268 15540270 15540271 15540272 15540273 15540274 15540276 15540277 15540278 15540279 15540280 15540282 15540283 15540284 15540285 15519753 15519754 15519755 15519756 15519757 15519758 15519759 15519760 15519761 15519762 15519763 15519764 15519765 15519766 15519767 15503435 15503437 15503439 15503441 15503443 15503444 15503445 15503447 15503448 15503450 15503452 15503453 15503454 15503456 15503457 15248264 15248266 15248267 15106149 15106150 15106151 15106152 15087939 15087940 15087941 15087942 15087943 15087944 15087945 15087947 15087948 15087951 15087952 15087954 15087955 15087956 15087957 15087958 15087959 15087960 15087961 15087962 15087963 15052089 15052090 14914250 14826833 14826834 14826835 14826836 14826837 14826838 14597398 14597399 15603399 15603401 15603402 15603403 15603404 15581896 17356056 17356058 17356060 17356061 17356062 14782343 14487085 14487091 14487092 14487095 14487096 14487097 14487098 14487099 14487101 14487102 14487103 14487104 14487105 14487106 14487108 14486068 14486069 14486070 14486071 14486072 14486073 14486074 14486075 14486076 15492383 14520920 14520921 14520922 14520924 14520925 14520926 14520927 14520928 14520929 14520930 14520931 14520932 14520933 14520934 14520935 14520937 15592931 15592932 15592933 15592934 15592937 15592938 15592939 15592941 15592943 15592944 15592945 15592946 15592947 1559…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of South Africa, Kuwait, Qatar, Singapore, Bermuda, United Arab Emirates, Argentina, Australia, Belgium, Bahrain, Brazil, Bahamas, Canada, Chile, China, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Italy, Japan, South Korea, Lebanon, Morocco, Mexico, New Zealand, Oman, Portugal, Thailand, Taiwan.
      status: recorded

FDA recall Z-1931-2024: CareFusion 303, Inc. is recalling BD Pyxis" Anesthesia Station ES, REF: 327
type: Claim
text: The FDA logged enforcement record Z-1931-2024: CareFusion 303, Inc. is voluntarily recalling BD Pyxis" Anesthesia Station ES, REF: 327 — reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-15. Affected lots/codes: UDI: 10885403512636/Serial numbers added 8/27/2025: 15662739 15662740 15662741 15662743 15662745 15662746 15662747 15662749 15662752 15662753 15662754 15662756 15662758 15662759 15662760 15662761 15662762 15662763 15662764 15662765 15662767 15662768 15662769 15662770 15662771 15662772 15662773 15662774 15662775 15375059 15757979 15757980 15755213 15755214 15755215 15755216 15755217 15755218 15022893 15022894 15022895 15022896 14284496 14284498 17700227 17414413 17276726 17215411 15689985 15689986 15566064 15566065 15566067 15566068 15566069 15566070 15566071 15566072 15566073 15566074 15566075 15566076 15566077 15566078 15566079 15540267 15540268 15540270 15540271 15540272 15540273 15540274 15540276 15540277 15540278 15540279 15540280 15540282 15540283 15540284 15540285 15519753 15519754 15519755 15519756 15519757 15519758 15519759 15519760 15519761 15519762 15519763 15519764 15519765 15519766 15519767 15503435 15503437 15503439 15503441 15503443 15503444 15503445 15503447 15503448 15503450 15503452 15503453 15503454 15503456 15503457 15248264 15248266 15248267 15106149 15106150 15106151 15106152 15087939 15087940 15087941 15087942 15087943 15087944 15087945 15087947 15087948 15087951 15087952 15087954 15087955 15087956 15087957 15087958 15087959 15087960 15087961 15087962 15087963 15052089 15052090 14914250 14826833 14826834 14826835 14826836 14826837 14826838 14597398 14597399 15603399 15603401 15603402 15603403 15603404 15581896 17356056 17356058 17356060 17356061 17356062 14782343 14487085 14487091 14487092 14487095 14487096 14487097 14487098 14487099 14487101 14487102 14487103 14487104 14487105 14487106 144871…
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-1931-2024 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.