Z-1468-2025.jsonld
type: Dataset
name: Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
description: FDA recall Z-1468-2025 — Baxter Healthcare Corporation is recalling Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S. (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: Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
  manufacturer: Baxter Healthcare Corporation
claims: enforcement-record
claims: FDA classified recall Z-1468-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1468-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1468-2025
      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: Baxter Healthcare Corporation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-02-25
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: P7520A19 UDI-DI: 00887761999893; P7520A20S UDI-DI: 00887761999886; P7520A21 UDI-DI: 00887761999879; P7520A22S UDI-DI: 00887761999862; P7520A23 UDI-DI: 00887761999855; P7520A24S UDI-DI: 00887761999848; P7520A3 UDI-DI: 00887761999770; P7520A31 UDI-DI: 00887761999756; P7520A37 UDI-DI: 00887761999718; P7520A39 UDI-DI: 00887761999701; P7520A45 UDI-DI: 00887761999671; P7520A4S UDI-DI: 00887761999657; Serial Numbers: A008MW1489 Y298MW1411 Y298MW1412 Y298MW1413 Y298MW1414 Y298MW1415 Y298MW1416 Y298MW1417 Y298MW1418 Y298MW1419 Y298MW1420 Y298MW1421 Y298MW1452 Y298MW1453 Y298MW1454 Y298MW1455 Y298MW1456 Y298MW1457 Y298MW1458 Y298MW1459 Y298MW1460 Y298MW1461 Y298MW1463 Y298MW1464 Y298MW1465 Y298MW1466 Y298MW1467 Y298MW1468 Y298MW1469 Y298MW1470 Y298MW1471 Y298MW1472 Y298MW1473 Y298MW1474 Y298MW1475 Y298MW1580 Y298MW1581 Y298MW1582 Y298MW1583 Y298MW1584 Y298MW1585 Y298MW1586 Y298MW1587 Y298MW1588 Y298MW1589 Y298MW1590 Y298MW1591 Y298MW1592 Y298MW1593 Y298MW1594 Y298MW1595 Y298MW1596 Y298MW1597 Y298MW1598 Y298MW1599 Y298MW1600 Y298MW1601 Y298MW1602 Y298MW1603 Y298MW1604 Y298MW1605 Y298MW1606 Y298MW1607 Y298MW1608 Y298MW1609 Y298MW1610 Y298MW1611 Y298MW1612 Y298MW1613 Y298MW1614 Y298MW1615 Y298MW1616 Y298MW1617 Y298MW1618 Y298MW1619 Y298MW1620 Y298MW1621 Y298MW1622 Y298MW1623 Y303MW2164 Y303MW2165 Y303MW2166 Y303MW2167 Y303MW2168 Y303MW2169 Y303MW2170 Y303MW2171 Y305MW2526 Y305MW2527 Y305MW2528 Y305MW2529 Y305MW2530 Y305MW2531 Y305MW2532 Y305MW2533 Y306MW2730 Y306MW2731 Y306MW2732 Y306MW2733 Y306MW2734 Y306MW2735 Y306MW2736 Y306MW2737 Y306MW2738 Y306MW2739 Y306MW2844 Y306MW2845 Y306MW2846 Y306MW2847 Y306MW2848 Y306MW2849 Y306MW2850 Y306MW2851 Y306MW2852 Y306MW2853 Y306MW2854 Y306MW2855 Y306MW2856 Y306MW2857 Y306MW2858 Y312MW3805 Y312MW3806 Y312MW3807 Y312MW3808 Y312MW3809 Y312MW3810 Y312MW3811 Y312MW3812 Y312MW3813 Y312MW3814 Y312MW3815 Y312MW3816 Y312MW3817 Y312MW3818 Y312MW3819 Y312MW3820 Y312MW3821 Y312MW3822 Y312MW3823 Y312MW3824 Y312MW3825 Y314MW4237 Y314MW4238 Y314MW4239 Y3…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide. Global Distribution.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1468-2025: Baxter Healthcare Corporation is recalling Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
text: The FDA logged enforcement record Z-1468-2025: Baxter Healthcare Corporation is voluntarily recalling Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S. — reason: The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-25. Affected lots/codes: P7520A19 UDI-DI: 00887761999893; P7520A20S UDI-DI: 00887761999886; P7520A21 UDI-DI: 00887761999879; P7520A22S UDI-DI: 00887761999862; P7520A23 UDI-DI: 00887761999855; P7520A24S UDI-DI: 00887761999848; P7520A3 UDI-DI: 00887761999770; P7520A31 UDI-DI: 00887761999756; P7520A37 UDI-DI: 00887761999718; P7520A39 UDI-DI: 00887761999701; P7520A45 UDI-DI: 00887761999671; P7520A4S UDI-DI: 00887761999657; Serial Numbers: A008MW1489 Y298MW1411 Y298MW1412 Y298MW1413 Y298MW1414 Y298MW1415 Y298MW1416 Y298MW1417 Y298MW1418 Y298MW1419 Y298MW1420 Y298MW1421 Y298MW1452 Y298MW1453 Y298MW1454 Y298MW1455 Y298MW1456 Y298MW1457 Y298MW1458 Y298MW1459 Y298MW1460 Y298MW1461 Y298MW1463 Y298MW1464 Y298MW1465 Y298MW1466 Y298MW1467 Y298MW1468 Y298MW1469 Y298MW1470 Y298MW1471 Y298MW1472 Y298MW1473 Y298MW1474 Y298MW1475 Y298MW1580 Y298MW1581 Y298MW1582 Y298MW1583 Y298MW1584 Y298MW1585 Y298MW1586 Y298MW1587 Y298MW1588 Y298MW1589 Y298MW1590 Y298MW1591 Y298MW1592 Y298MW1593 Y298MW1594 Y298MW1595 Y298MW1596 Y298MW1597 Y298MW1598 Y298MW1599 Y298MW1600 Y298MW1601 Y298MW1602 Y298MW1603 Y298MW1604 Y298MW1605 Y298MW1606 Y298MW1607 Y298MW1608 Y298MW1609 Y298MW1610 Y298MW1611 Y298MW1612 Y298MW1613 Y298MW1614 Y298MW1615 Y298MW1616 Y298MW1617 Y298MW1618 Y298MW1619 Y298MW1620 Y298MW1621 Y298MW1622 Y298MW1623 Y303MW2164 Y303MW2165 Y303MW2166 Y303MW2167 Y303MW2168 Y303MW2169 Y303MW2170 Y303MW2171 Y305MW2526 Y305MW25…
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-1468-2025 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.