Z-1050-2025.jsonld
type: Dataset
name: BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.
description: FDA recall Z-1050-2025 — CareFusion 303, Inc. is recalling BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider. (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: MedicalDevice
  name: BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.
  manufacturer: CareFusion 303, Inc.
claims: enforcement-record
claims: FDA classified recall Z-1050-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1050-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1050-2025
      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: Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.
      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: BD Pyxis MedStation ES AUX Tower Catalog Number: 343 UDI-DI code: 10885403512698 Serial Number/Equipment Number: 14535900 14535900 14535901 14535901 14535902 14535902 14535903 14535903 14535904 14535904 14535905 14535905 14535906 14535906 14535907 14535907 14535908 14535908 14535910 14535910 14535912 14535912 14535913 14535913 14535916 14535916 14535919 14535919 14535922 14535922 14535924 14535924 14535926 14535926 14535928 14535928 14535930 14535930 14535932 14535932 14535934 14535934 14535936 14535936 14535937 14535937 14535939 14535939 14535941 14535941 14535943 14535943 14535945 14535945 14535947 14535947 14535949 14535949 14535951 14535951 14535953 14535953 14535954 14535954 14535956 14535956 14535958 14535958 14535960 14535960 14535962 14535962 14535964 14535964 14535966 14535966 14549572 14549572 14549573 14549573 14549574 14549574 14549575 14549575 14549576 14549576 14549577 14549577 14651270 14651270 14651271 14651271 14651282 14651282 14651297 14651297 14651298 14651298 14651299 14651299 14651314 14651314 14651315 14651315 14651316 14651316 14651317 14651317 14651357 14651357 14651358 14651358 14651359 14651359 14651390 14651390 14703129 14703129 14703130 14703130 14703131 14703131 14735444 14735444 14735445 14735445 14735446 14735446 14735447 14735447 14735448 14735448 14753109 14753109 14753111 14753111 14753112 14753112 14753126 14753126 14753127 14753127 14753128 14753128 14753129 14753129 14753130 14753130 14753131 14753131 14753132 14753132 14753145 14753145 14753146 14753146 14753147 14753147 14753148 14753148 14753149 14753149 14753150 14753150 14753167 14753167 14753177 14753177 14753182 14753182 14753184 14753184 14768245 14768245 14891921 14891921 14891922 14891922 14891923 14891923 14891924 14891924 14916994 14916994 14916995 14916995 14916996 14916996 14916997 14916997 14916998 14916998 14916999 14916999 14917000 14917000 14917001 14917001 14917002 14917002 14917003 14917003 14917004 14917004 14917005 14917005 14917006 14917006 14917007 149170…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: U.S.: 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Germany and Japan
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1050-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.
text: The FDA logged enforcement record Z-1050-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider. — reason: Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-14. Affected lots/codes: BD Pyxis MedStation ES AUX Tower Catalog Number: 343 UDI-DI code: 10885403512698 Serial Number/Equipment Number: 14535900 14535900 14535901 14535901 14535902 14535902 14535903 14535903 14535904 14535904 14535905 14535905 14535906 14535906 14535907 14535907 14535908 14535908 14535910 14535910 14535912 14535912 14535913 14535913 14535916 14535916 14535919 14535919 14535922 14535922 14535924 14535924 14535926 14535926 14535928 14535928 14535930 14535930 14535932 14535932 14535934 14535934 14535936 14535936 14535937 14535937 14535939 14535939 14535941 14535941 14535943 14535943 14535945 14535945 14535947 14535947 14535949 14535949 14535951 14535951 14535953 14535953 14535954 14535954 14535956 14535956 14535958 14535958 14535960 14535960 14535962 14535962 14535964 14535964 14535966 14535966 14549572 14549572 14549573 14549573 14549574 14549574 14549575 14549575 14549576 14549576 14549577 14549577 14651270 14651270 14651271 14651271 14651282 14651282 14651297 14651297 14651298 14651298 14651299 14651299 14651314 14651314 14651315 14651315 14651316 14651316 14651317 14651317 14651357 14651357 14651358 14651358 14651359 14651359 14651390 14651390 14703129 14703129 14703130 14703130 14703131 14703131 14735444 14735444 14735445 14735445 14735446 14735446 14735447 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-1050-2025 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.