BD Pyxis MedStation ES, REF: 323
type: Dataset
description: FDA recall Z-0670-2025 — CareFusion 303, Inc. is recalling BD Pyxis MedStation ES, REF: 323 (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, REF: 323
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-0670-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation ES, REF: 323
claims: FDA classified recall Z-0670-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0670-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0670-2025
      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 a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-11-14
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: All software versions. REF/UDI-DI: 323/10885403512667/ 12441103 12440974 12440975 12441333 12441432 12447684 12455493 12455498 12455492 12455793 12458864 12463612 12470842 12476547 12482532 12483393 12486737 12499043 12499838 12499616 12499617 12499618 12505982 12508303 12514216 12514218 12514217 12514220 12515358 12522942 12527930 12528710 12528709 12530090 12531418 12537364 12537363 12537076 12540196 12540194 12540267 12540268 12540269 12561139 12568697 12569170 12570749 12570750 12570745 12570746 12570748 12570753 12585184 12585183 12586285 12589659 12589685 12589658 12589618 12589657 12593259 12594318 12594322 12596587 12596404 12597477 12597478 12597479 12597474 12597489 12597491 12597492 12597493 12597475 12598838 12599570 12599571 12599063 12599064 12599065 12599067 12599069 12599066 12599070 12599061 12599062 12599135 12599136 12599138 12599140 12599137 12599141 12599139 12599971 12600268 12599970 12600435 12600467 12600468 12600469 12600690 12600687 12600689 12600691 12602140 12602358 12602360 12602357 12602359 12602372 12602361 12605985 12606524 12608631 12611808 12611816 12611926 12612669 12612567 12615383 12616239 12624466 12626212 12629311 12629309 12629602 12629604 12629603 12629627 12630890 12632195 12633312 12638031 12637962 12637963 12637961 12638017 12638018 12639538 12650679 12650091 12652625 12653147 12653602 12655694 12656692 12656693 12656812 12658185 12659515 12662647 12662921 12666199 12666200 12676117 12678689 12681469 12681569 12683904 12685086 12685088 12685085 12685090 12685091 12685137 12685087 12685089 12686327 12687145 12687229 12688452 12688464 12688454 12690063 12693218 12693928 12693868 12693933 12693869 12693870 12695277 12695293 12695764 12696506 12696505 12696508 12696507 12696750 12696764 12696748 12696749 12696763 12697337 12697340 12697336 12697339 12697341 12697335 12698086 12698076 12697996 12698384 12699329 12699611 12701481 12702050 12702960 12702974 12703634 12703641 12704148 12704149 12704840 12704844 12705614 12705641 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.
      status: recorded

FDA recall Z-0670-2025: CareFusion 303, Inc. is recalling BD Pyxis MedStation ES, REF: 323
type: Claim
text: The FDA logged enforcement record Z-0670-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis MedStation ES, REF: 323 — reason: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-14. Affected lots/codes: All software versions. REF/UDI-DI: 323/10885403512667/ 12441103 12440974 12440975 12441333 12441432 12447684 12455493 12455498 12455492 12455793 12458864 12463612 12470842 12476547 12482532 12483393 12486737 12499043 12499838 12499616 12499617 12499618 12505982 12508303 12514216 12514218 12514217 12514220 12515358 12522942 12527930 12528710 12528709 12530090 12531418 12537364 12537363 12537076 12540196 12540194 12540267 12540268 12540269 12561139 12568697 12569170 12570749 12570750 12570745 12570746 12570748 12570753 12585184 12585183 12586285 12589659 12589685 12589658 12589618 12589657 12593259 12594318 12594322 12596587 12596404 12597477 12597478 12597479 12597474 12597489 12597491 12597492 12597493 12597475 12598838 12599570 12599571 12599063 12599064 12599065 12599067 12599069 12599066 12599070 12599061 12599062 12599135 12599136 12599138 12599140 12599137 12599141 12599139 12599971 12600268 12599970 12600435 12600467 12600468 12600469 12600690 12600687 12600689 12600691 12602140 12602358 12602360 12602357 12602359 12602372 12602361 12605985 12606524 12608631 12611808 12611816 12611926 12612669 12612567 12615383 12616239 12624466 12626212 12629311 12629309 12629602 12629604 12629603 12629627 12630890 12632195 12633312 12638031 12637962 12637963 12637961 12638017 12638018 12639538 12650679 12650091 12652625 12653147 12653602 12655694 12656692 12656693 12656812 12658185 12659515 12662647 12662921 12666199 12…
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-0670-2025 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.