BD Pyxis Med ES Auxiliary (AUX), REF 343
type: Dataset
description: FDA recall Z-0975-2025 — CareFusion 303, Inc. is recalling BD Pyxis Med ES Auxiliary (AUX), REF 343 (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 Med ES Auxiliary (AUX), REF 343
  type: MedicalDevice
  manufacturer: CareFusion 303, Inc.
claims: FDA recall Z-0975-2025: CareFusion 303, Inc. is recalling BD Pyxis Med ES Auxiliary (AUX), REF 343
claims: FDA classified recall Z-0975-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0975-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0975-2025
      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: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
      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: UDI/DI 10885403512698, Serial Numbers: 16171753, 16191650, 16192894, 16144435, 16154605, 16154606, 16154607, 16191713, 16191714, 16191715, 16191716, 16191718, 16191719, 16191720, 16191721, 16191722, 16196167, 16186595, 16196168, 16196169, 16186597, 16196170, 16196172, 16163310, 16179747, 16168959, 16167684, 16163677, 16185817, 16188363, 16188367, 16188695, 16185802, 16188322, 16191726, 16173525, 16173527, 16173528, 16194920, 16194922, 16190720, 16186580, 16191729, 16191730, 16191876, 16191877, 16191878, 16191879, 16166841, 16166842, 16182585, 16183929, 16178220, 16178222, 16179754, 16179750, 16179751, 16179752, 16179756, 16179757, 16179758, 16179759, 16179761, 16179762, 16184811, 16179764, 16179753, 16179765, 16179766, 16179767, 16179768, 16191682, 16191683, 16191684, 16188702, 16188705, 16172879, 16190710, 16190711, 16177195, 16177196, 16177199, 16177368, 16177369, 16191880, 16191881, 16188361, 16188364, 16188694, 16189315, 16173027, 16180723, 16173028, 16162674, 16186590, 16166843, 16177168, 16163837, 16172982, 16172983, 16164738, 16164740, 16172987, 16172989, 16166814, 16191646, 16182586, 16178208, 16179763, 16154507, 16154508, 16168957, 16147503, 16188768, 16191685, 16190713, 16197442, 16188355, 16196904, 16196905, 16196906, 16196907, 16196910, 16196916, 16192954, 16192955, 16192956, 16185809, 16192957, 16185810, 16185811, 16185812, 16188765, 16203246, 16126735, 16196903, 16196908, 16196915, 16196917, 16178206, 16178207, 16185544, 16180801, 16196932, 16184893, 16184894, 16188359, 16188360, 16188362, 16188365, 16188697, 16188735, 16172984, 16172986, 16172990, 16172991, 16172992, 16161338, 16197445, 16197446, 16197448, 16197449, 16163319, 16172880, 16154485, 16154486, 16154498, 16154499, 16154382, 16154383, 16154384, 16154466, 16154470, 16154504, 16154506, 16150226, 16150243, 16199333, 16199334, 16199335, 16199336, 16199337, 16199338, 16199339, 16199340, 16199341, 16199342, 16199343, 16199344, 16199345, 16199346, 16199347, 16199348, 16199349, 16199350, 16199351, 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0975-2025: CareFusion 303, Inc. is recalling BD Pyxis Med ES Auxiliary (AUX), REF 343
type: Claim
text: The FDA logged enforcement record Z-0975-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis Med ES Auxiliary (AUX), REF 343 — reason: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-14. Affected lots/codes: UDI/DI 10885403512698, Serial Numbers: 16171753, 16191650, 16192894, 16144435, 16154605, 16154606, 16154607, 16191713, 16191714, 16191715, 16191716, 16191718, 16191719, 16191720, 16191721, 16191722, 16196167, 16186595, 16196168, 16196169, 16186597, 16196170, 16196172, 16163310, 16179747, 16168959, 16167684, 16163677, 16185817, 16188363, 16188367, 16188695, 16185802, 16188322, 16191726, 16173525, 16173527, 16173528, 16194920, 16194922, 16190720, 16186580, 16191729, 16191730, 16191876, 16191877, 16191878, 16191879, 16166841, 16166842, 16182585, 16183929, 16178220, 16178222, 16179754, 16179750, 16179751, 16179752, 16179756, 16179757, 16179758, 16179759, 16179761, 16179762, 16184811, 16179764, 16179753, 16179765, 16179766, 16179767, 16179768, 16191682, 16191683, 16191684, 16188702, 16188705, 16172879, 16190710, 16190711, 16177195, 16177196, 16177199, 16177368, 16177369, 16191880, 16191881, 16188361, 16188364, 16188694, 16189315, 16173027, 16180723, 16173028, 16162674, 16186590, 16166843, 16177168, 16163837, 16172982, 16172983, 16164738, 16164740, 16172987, 16172989, 16166814, 16191646, 16182586, 16178208, 16179763, 16154507, 16154508, 16168957, 16147503, 16188768, 16191685, 16190713, 16197442, 16188355, 16196904, 16196905, 16196906, 16196907, 16196910, 16196916, 16192954, 16192955, 16192956, 16185809, 16192957, 16185810, 16185811, 16185812, 16188765, 16203246, 16126735, 16196903, 16196908, 16196915, 16196917, 16178206, 16178207, 16185544, 16180801, 161969…
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-0975-2025 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.