Z-1482-2023.jsonld
type: Dataset
name: Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t) P7924A02, u) P7924A03, v) P7924A04, w) P7924ARENT01
description: FDA recall Z-1482-2023 — Baxter Healthcare Corporation is recalling Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t) P7924A02, u) P7924A03, v) P7924A04, w) P7924ARENT01 (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: Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t) P7924A02, u) P7924A03, v) P7924A04, w) P7924ARENT01
  manufacturer: Baxter Healthcare Corporation
claims: enforcement-record
claims: FDA classified recall Z-1482-2023 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1482-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1482-2023
      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: Baxter Healthcare Corporation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-03-31
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: a) 20877002S, UDI/DI N/A, Serial Numbers: W315BP5905, W315BP5907, W315BP5910, W315BP5911; b) 20877003S, UDI/DI N/A, Serial Numbers: W301BP5612, W301BP5615; c) 20877004S, UDI/DI N/A, Serial Numbers: W231BP4205, W238BP4341, W238BP4342, W238BP4343, W238BP4345, W238BP4347, W238BP4348, W238BP4349, W246BP4519, W246BP4525, W246BP4526, W245BP4502, W245BP4503, W246BP4510, W246BP4511, W246BP4513, W246BP4514, W246BP4520, W246BP4521, W246BP4523, W246BP4524, W252BP4622, W252BP4629, W252BP4634, W252BP4636, W246BP4505, W246BP4512, W252BP4612, W252BP4618, W252BP4620, W256BP4671, W256BP4673, W287BP5300, W287BP5301, W287BP5302, W322BP6072, W322BP6076,; d) 20877007S, UDI/DI N/A, Serial Numbers: W299BP5609, W299BP5611; e) 20877008S, UDI/DI N/A, Serial Numbers: W301BP5616, W301BP5621; f) 21649301S, UDI/DI N/A, Serial Numbers: W188TP7991, W188TP7992, W188TP7993, W188TP7994, W188TP7995, W188TP7996, W188TP7997, W188TP7998; g) 21649401S, UDI/DI N/A, Serial Numbers: W188TP8006, W188TP8007, W188TP8008, W188TP8009, W188TP8010, W188TP8011; h) 21649402S, UDI/DI N/A, Serial Numbers: W188TP7999, W188TP8000, W188TP8002, W188TP8003, W188TP8004, W188TP8005; i) P006800A01, UDI/DI 00887761977846, Serial Numbers: V314BP0017, V328BP0145, V328BP0146, V328BP0147, V328BP0148, V328BP0149, V328BP0150, V328BP0151, V328BP0152, V328BP0153, V328BP0154, V328BP0156, V328BP0159, V328BP0155, V328BP0157, V328BP0158, V330BP0160, V330BP0161, V330BP0163, V330BP0166, V330BP0167; j) P006800A02, UDI/DI 00887761977839, Serial Numbers: V314BP0023, V314BP0027; k) P3255A01, UDI/DI 00887761977860, Serial Numbers: V301BP0010, V301BP0011, V301BP0012, V314BP0018, V314BP0021, V314BP0026, V314BP0019, V314BP0032, V314BP0020, V314BP0029, V314BP0030, V314BP0031, V314BP0034, V314BP0036, V323BP0080, V325BP0109, V326BP0120, W012BP0498, W036BP0623, W036BP0624, W036BP0625, W036BP0626, W036BP0627, W036BP0628, W036BP0629, W036BP0630, W036BP0631, W036BP0633, W036BP0634, W036BP0635, W036BP0636, W036BP0637, W036BP0638, W036BP0639, W036BP0640, W03…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution - US Nationwide and the countries of Canada, Qatar.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1482-2023: Baxter Healthcare Corporation is recalling Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t) P7924A02, u) P7924A03, v) P7924A04, w) P7924ARENT01
text: The FDA logged enforcement record Z-1482-2023: Baxter Healthcare Corporation is voluntarily recalling Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t) P7924A02, u) P7924A03, v) P7924A04, w) P7924ARENT01 — reason: There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-03-31. Affected lots/codes: a) 20877002S, UDI/DI N/A, Serial Numbers: W315BP5905, W315BP5907, W315BP5910, W315BP5911; b) 20877003S, UDI/DI N/A, Serial Numbers: W301BP5612, W301BP5615; c) 20877004S, UDI/DI N/A, Serial Numbers: W231BP4205, W238BP4341, W238BP4342, W238BP4343, W238BP4345, W238BP4347, W238BP4348, W238BP4349, W246BP4519, W246BP4525, W246BP4526, W245BP4502, W245BP4503, W246BP4510, W246BP4511, W246BP4513, W246BP4514, W246BP4520, W246BP4521, W246BP4523, W246BP4524, W252BP4622, W252BP4629, W252BP4634, W252BP4636, W246BP4505, W246BP4512, W252BP4612, W252BP4618, W252BP4620, W256BP4671, W256BP4673, W287BP5300, W287BP5301, W287BP5302, W322BP6072, W322BP6076,; d) 20877007S, UDI/DI N/A, Serial Numbers: W299BP5609, W299BP5611; e) 20877008S, UDI/DI N/A, Serial Numbers: W301BP5616, W301BP5621; f) 21649301S, UDI/DI N/A, Serial Numbers: W188TP7991, W188TP7992, W188TP7993, W188TP7994, W188TP7995, W188TP7996, W188TP7997, W188TP7998; g) 21649401S, UDI/DI N/A, Serial Numbers: W188TP8006, W188TP8007, W188TP8008, W188TP8009, W188TP8010, W188TP8011; h) 21649402S, UDI/DI N/A, Serial Numbers: W188TP7999, W188TP8000, W188TP8002, W188TP8003, W188TP8004, W188TP8005; i) P006800A01, UDI/DI 00887761977846, Serial Numbers: V314BP0017, V328BP0145, V328BP0146, V328BP0147, V328BP0148, V328BP0149, V328BP0150, V328BP0151, …
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-1482-2023 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.