BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
type: Dataset
description: FDA recall Z-1123-2025 — CareFusion 303, Inc. is recalling BD Pyxis MedStation Auxiliary ES REF: 324. 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: BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: enforcement-record
claims: FDA classified recall Z-1123-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1123-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1123-2025
      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: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-02-23
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI: 10885403512681/ Serial Numbers: 16183869 16183877 16181308 16181309 16184719 16184720 16155214 16167998 16173711 16173716 16173724 16173725 16173726 16173727 16173728 16156524 16156529 16163412 16163413 16163416 16163417 16163418 16163420 16155945 16182183 16182295 16182298 16184712 16187332 16173521 16173523 16190551 16190552 16190553 16190554 16167592 16185663 16188550 16188551 16188560 16188561 16173437 16173439 16103949 16173522 16177055 16177056 16173680 16173681 16173714 16173717 16173718 16173719 16173721 16173722 16173723 16177910 16185638 16188602 16188603 16192625 16192634 16182181 16182185 16200812 16169401 16167449 16167996 16162741 16162739 16162742 16162743 16162744 16162745 16161320 16161322 16161324 16167522 16194353 16183841 16183843 16195336 16156521 16144089 16144090 16144095 16144096 16145983 16167581 16167583 16167585 16167587 16167589 16192307 16192309 16192622 16192627 16192631 16102579 16196727 16196729 16196626 16195229 16192630 16196649 16192240 16173615 16173616 16177914 16198683 16194363 16195232 16182179 16182180 16182182 16182292 16182296 16182297 16164498 16192308 16155092 16153374 16155093 16155086 16149567 16149568 16168891 16168893 16161075 16161077 16109954 16161082 16161083 16183881 16184147 16184177 16195332 16195334 16195338 16155966 16155967 16155968 16187307 16187312 16187314 16187318 16167351 16195841 16183868 16183879 16200806 16167457 16187702 16187716 16187718 16187720 16187722 16187725 16187732 16187736 16190308 16196664 16198551 16200827 16200828 16200831 16080977 16167445 16167446 16172514 16162529 16161071 16161073 16161076 16188224 16188225 16184150 16184162 16161349 16161350 16183849 16183850 16146702 16187738 16187739 16187742 16187743 16187744 16187745 16187746 16048532 16048533 16176335 16176336 16177014 16177020 16177021 16177026 16177041 16177042 16177043 16188975 16188978 16185612 16185613 16185616 16185619 16185620 16185622 16177830 16177833 16177835 16177836 16177837 16177842 16177844 16167650 16167340 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US: Nationwide OUS:JP IT IN DE GB KR NL TW ES BE AU BH CA BR NZ FR AR QA MX CL TR SA MY CH IL IE TH SG KW MA FI AE EG BS BM GR MC PL LB MO IQ TN NO PH CN HK CO JO OM
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1123-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
text: The FDA logged enforcement record Z-1123-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider. — reason: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-23. Affected lots/codes: UDI: 10885403512681/ Serial Numbers: 16183869 16183877 16181308 16181309 16184719 16184720 16155214 16167998 16173711 16173716 16173724 16173725 16173726 16173727 16173728 16156524 16156529 16163412 16163413 16163416 16163417 16163418 16163420 16155945 16182183 16182295 16182298 16184712 16187332 16173521 16173523 16190551 16190552 16190553 16190554 16167592 16185663 16188550 16188551 16188560 16188561 16173437 16173439 16103949 16173522 16177055 16177056 16173680 16173681 16173714 16173717 16173718 16173719 16173721 16173722 16173723 16177910 16185638 16188602 16188603 16192625 16192634 16182181 16182185 16200812 16169401 16167449 16167996 16162741 16162739 16162742 16162743 16162744 16162745 16161320 16161322 16161324 16167522 16194353 16183841 16183843 16195336 16156521 16144089 16144090 16144095 16144096 16145983 16167581 16167583 16167585 16167587 16167589 16192307 16192309 16192622 16192627 16192631 16102579 16196727 16196729 16196626 16195229 16192630 16196649 16192240 16173615 16173616 16177914 16198683 16194363 16195232 16182179 16182180 16182182 16182292 16182296 16182297 16164498 16192308 16155092 16153374 16155093 16155086 16149567 16149568 16168891 16168893 16161075 16161077 16109954 16161082 16161083 16183881 16184147 16184177 16195332 16195334 16195338 16155966 16155967 16155968 16187307 16187312 16187314 16187318 16167351 16195841 16183868 16183879 16200806 16167457 16187702 16187716 16187718 16187720 16187722 16187725 16187732 16187…
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-1123-2025 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.