BD Pyxis(TM) Anesthesia Station 4000, REF: 338
type: Dataset
description: FDA recall Z-1932-2024 — CareFusion 303, Inc. is recalling BD Pyxis(TM) Anesthesia Station 4000, REF: 338 (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(TM) Anesthesia Station 4000, REF: 338
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-1932-2024: CareFusion 303, Inc. is recalling BD Pyxis(TM) Anesthesia Station 4000, REF: 338
claims: FDA classified recall Z-1932-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1932-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1932-2024
      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: 10885403477829/ Serial Numbers provided 8/27/2025: 15549257 14897663 14895303 14895304 14895305 14895306 14895307 14895308 14895309 14895310 14895311 14877974 14819696 14956425 14956427 14956428 14956429 14956431 14956432 14622884 14622885 15091720 14546469 14361326 14361327 15019611 15019612 15019613 15019614 15019615 15019616 15019617 15019618 15019619 15019620 15289651 14558594 14558595 14558596 14558597 14558598 14558599 14558600 14558601 14558602 14558604 14558605 14558606 14558607 14384234 14384236 14384238 14384240 14384241 14384243 14384244 14384245 14384246 14384247 14384248 13932078 13932079 13932080 13932081 15507816 14379194 14379727 14379729 14379730 14379731 14379732 14379733 14379734 14379735 14379736 14379737 14379738 14379740 14379741 14379811 14379812 14379813 14379816 14379817 14379972 14379973 14379974 14379975 14379718 14379719 14379720 14379721 14379722 14379723 14379724 14379725 14379726 13859536 13859549 14544175 14544176 14544178 14544180 14544181 14567021 14544171 14544172 14544174 14544158 14544159 14544160 14544161 14544162 14544163 14544165 14544167 14544168 14544169 14544170 14385503 13970089 13970091 13970093 13970096 13970097 13970099 13970102 13970106 13970110 13970111 13970112 13970113 15159053 15159054 15159055 15159056 14292960 14292961 14292962 14292963 14292964 14292965 14292966 14292967 14292968 14292970 14292973 14292974 14292975 14292976 14292977 14292978 14292979 14292981 14292983 14292985 15263558 14472899 14380818 14039816 14039817 14039818 14039819 14039820 14039822 14039824 14039825 14039826 14039827 14039828 14039829 14039830 14039831 14039832 14039833 14039834 14039835 14039836 14039837 14039838 14039839 14039840 14039841 13908525 13908526 13908527 13908528 13908529 13908530 13908531 13908532 13888650 13888651 13888654 13888656 14956440 13908513 13908514 13908515 13908516 13908517 13908518 13908519 13908520 13908521 13908522 13908523 13908524 14628633 14627521 14610330 14610331 14610332 14610333 14610334 14610335 …
      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-1932-2024: CareFusion 303, Inc. is recalling BD Pyxis(TM) Anesthesia Station 4000, REF: 338
type: Claim
text: The FDA logged enforcement record Z-1932-2024: CareFusion 303, Inc. is voluntarily recalling BD Pyxis(TM) Anesthesia Station 4000, REF: 338 — 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: 10885403477829/ Serial Numbers provided 8/27/2025: 15549257 14897663 14895303 14895304 14895305 14895306 14895307 14895308 14895309 14895310 14895311 14877974 14819696 14956425 14956427 14956428 14956429 14956431 14956432 14622884 14622885 15091720 14546469 14361326 14361327 15019611 15019612 15019613 15019614 15019615 15019616 15019617 15019618 15019619 15019620 15289651 14558594 14558595 14558596 14558597 14558598 14558599 14558600 14558601 14558602 14558604 14558605 14558606 14558607 14384234 14384236 14384238 14384240 14384241 14384243 14384244 14384245 14384246 14384247 14384248 13932078 13932079 13932080 13932081 15507816 14379194 14379727 14379729 14379730 14379731 14379732 14379733 14379734 14379735 14379736 14379737 14379738 14379740 14379741 14379811 14379812 14379813 14379816 14379817 14379972 14379973 14379974 14379975 14379718 14379719 14379720 14379721 14379722 14379723 14379724 14379725 14379726 13859536 13859549 14544175 14544176 14544178 14544180 14544181 14567021 14544171 14544172 14544174 14544158 14544159 14544160 14544161 14544162 14544163 14544165 14544167 14544168 14544169 14544170 14385503 13970089 13970091 13970093 13970096 13970097 13970099 13970102 13970106 13970110 13970111 13970112 13970113 15159053 15159054 15159055 15159056 14292960 14292961 14292962 14292963 14292964 14292965 14292966 14292967 14292968 14292970 14292973 14292974 14292975 14292976 14292977 14292978 14292979 14292981 14292983 14292985 15263558 14472899 14380818 14039816 14039817 14039818 14039819 14039820 14039822 14039824 14039825 14039826 14039827 14039828 14039829 14039830 14039831 14039832 14039833 140398…
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-1932-2024 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.