BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
type: Dataset
description: FDA recall Z-1122-2025 — CareFusion 303, Inc. is recalling BD Pyxis MedStation ES (Med ES Main) REF: 323. 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 ES (Med ES Main) REF: 323. 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-1122-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1122-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1122-2025
      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: 0885403212667/Serial Numbers: 16160944 16142237 16188205 16188207 16188212 16188216 16188220 16188229 16130230 16130231 16183872 16184152 16180604 16155071 16172476 16161355 16184716 16184717 16155208 16155209 16155210 16155211 16155212 16155213 16156000 16156004 16156006 16156008 16156018 16145933 16180546 16180547 16180548 16161088 16183862 16173683 16173684 16173685 16173686 16173687 16173696 16173698 16173701 16173702 16173703 16168000 16173704 16173705 16164513 16164517 16155941 16155943 16167578 15925963 16145929 16145930 16130236 16145931 16145932 16183776 16183781 16183784 16183789 16183792 16183801 16183804 16161294 16184711 16184713 16187331 16190475 16161087 16173513 16173514 16173515 16179685 16173518 16179683 16173529 16179596 16168002 16177915 16188887 16177921 16190561 16185661 16185662 16188555 16188556 16188557 16188558 16188559 16188562 16188564 16188565 16188566 16188567 16188568 16188569 16188570 16188571 16173435 16173436 16173438 16173440 16160946 16161016 16161060 16161065 16183829 16183830 16183832 16183833 16183835 16183836 16183837 16183848 16173517 16173679 16173682 16173690 16173692 16173693 16173694 16173695 16173697 16173699 16173700 16173706 16173709 16173713 16177907 16177908 16177909 16194589 16164428 16185637 16185639 16185640 16195920 16188597 16188598 16188599 16192623 16192624 16192632 16192633 16192635 16155435 16182337 16183778 16183782 16183791 16183797 16183798 16195917 16195918 16186373 16186375 16186376 16167488 16167489 16167490 16155336 16168907 16188870 16188878 16188879 16188885 16188888 16188889 16188890 16188904 16172996 16172997 16190471 16162843 16162844 16162845 16162796 16162797 16162798 16163232 16162799 16193839 16155217 16155218 16155220 16155222 16155224 16155225 16145934 16161406 16161384 16161387 16161388 16161389 16161390 16161395 16161397 16161398 16161336 16161337 16161321 16161323 16162753 16162754 16162756 16162761 16162762 16162768 16162726 16195804 16188871 16188872 16188873 16188874 16188875 161…
      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-1122-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
text: The FDA logged enforcement record Z-1122-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis MedStation ES (Med ES Main) REF: 323. 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: 0885403212667/Serial Numbers: 16160944 16142237 16188205 16188207 16188212 16188216 16188220 16188229 16130230 16130231 16183872 16184152 16180604 16155071 16172476 16161355 16184716 16184717 16155208 16155209 16155210 16155211 16155212 16155213 16156000 16156004 16156006 16156008 16156018 16145933 16180546 16180547 16180548 16161088 16183862 16173683 16173684 16173685 16173686 16173687 16173696 16173698 16173701 16173702 16173703 16168000 16173704 16173705 16164513 16164517 16155941 16155943 16167578 15925963 16145929 16145930 16130236 16145931 16145932 16183776 16183781 16183784 16183789 16183792 16183801 16183804 16161294 16184711 16184713 16187331 16190475 16161087 16173513 16173514 16173515 16179685 16173518 16179683 16173529 16179596 16168002 16177915 16188887 16177921 16190561 16185661 16185662 16188555 16188556 16188557 16188558 16188559 16188562 16188564 16188565 16188566 16188567 16188568 16188569 16188570 16188571 16173435 16173436 16173438 16173440 16160946 16161016 16161060 16161065 16183829 16183830 16183832 16183833 16183835 16183836 16183837 16183848 16173517 16173679 16173682 16173690 16173692 16173693 16173694 16173695 16173697 16173699 16173700 16173706 16173709 16173713 16177907 16177908 16177909 16194589 16164428 16185637 16185639 16185640 16195920 16188597 16188598 16188599 16192623 16192624 16192632 16192633 16192635 16155435 16182337 16183778 16183782 16183791 16183797 16183798 16195917 16195918 16186373 16186375 161…
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-1122-2025 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.