Z-2130-2023.jsonld
type: Dataset
name: Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
description: FDA recall Z-2130-2023 — Stryker Medical Division of Stryker Corporation is recalling Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507 (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: Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
  manufacturer: Stryker Medical Division of Stryker Corporation
claims: enforcement-record
claims: FDA classified recall Z-2130-2023 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2130-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2130-2023
      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: Stryker Medical Division of Stryker Corporation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-05-24
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Model: 650700000000 UDI-DI: 07613327504460; Model: 650705550001 UDI-DI: 07613327559118; Model: 650705550002 UDI-DI: 07613327559125; Cots shipped between February 11, 2022 and February 1, 2023 Serial Numbers: 2112001485 2112001488 2112001489 2112001490 2112001491 2112001492 2112001493 2112001494 2112001495 2112001496 2112001501 2112001503 2112001504 2112001508 2112001509 2112001510 2112001511 2112001512 2112001513 2112001514 2112001515 2112001516 2112001517 2112001518 2112001519 2112001520 2112001521 2112001522 2112001523 2112001524 2112001525 2112001526 2112001527 2112001528 2112001529 2112001530 2112001531 2112001532 2112001533 2112001534 2112001535 2112001536 2202000473 2202000474 2202000475 2202000476 2202000477 2202000478 2202000479 2202000480 2202000481 2202000482 2202000483 2202000484 2202000485 2202000487 2202000488 2202000489 2202000490 2202000491 2202000492 2202000797 2202000798 2202000799 2202000800 2202000801 2202000802 2202000803 2202000804 2202000805 2202000806 2202000807 2202000808 2202000809 2202000810 2202000811 2202000812 2202000813 2202000814 2202000815 2202000816 2202000817 2202000819 2202000820 2202000821 2202000822 2202000823 2202000824 2202000825 2202000826 2202001299 2202001300 2202001301 2202001302 2202001303 2202001304 2202001305 2202001306 2202001307 2202001308 2202001309 2202001311 2202001312 2202001313 2202001314 2202001315 2202001316 2202001317 2202001318 2202001518 2202001519 2202001520 2202001521 2202001522 2202001523 2202001524 2202001526 2202001535 2202001539 2202001541 2202001544 2202001545 2202001546 2202001547 2202001548 2202001549 2202001552 2202001554 2202001555 2202001556 2202001557 2202001558 2202001560 2202001561 2202001562 2202001563 2202001564 2202001565 2202001566 2202001568 2202001569 2202001570 2202001572 2202001573 2202001574 2202001575 2202001576 2202001577 2202001578 2202001579 2202001580 2202001582 2202001584 2202001585 2202001587 2202001590 2202001591 2202001592 2202001593 2202001594 2202001597 2202001795 2202001796…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Switzerland, United Kingdom.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-2130-2023: Stryker Medical Division of Stryker Corporation is recalling Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
text: The FDA logged enforcement record Z-2130-2023: Stryker Medical Division of Stryker Corporation is voluntarily recalling Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507 — reason: Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-24. Affected lots/codes: Model: 650700000000 UDI-DI: 07613327504460; Model: 650705550001 UDI-DI: 07613327559118; Model: 650705550002 UDI-DI: 07613327559125; Cots shipped between February 11, 2022 and February 1, 2023 Serial Numbers: 2112001485 2112001488 2112001489 2112001490 2112001491 2112001492 2112001493 2112001494 2112001495 2112001496 2112001501 2112001503 2112001504 2112001508 2112001509 2112001510 2112001511 2112001512 2112001513 2112001514 2112001515 2112001516 2112001517 2112001518 2112001519 2112001520 2112001521 2112001522 2112001523 2112001524 2112001525 2112001526 2112001527 2112001528 2112001529 2112001530 2112001531 2112001532 2112001533 2112001534 2112001535 2112001536 2202000473 2202000474 2202000475 2202000476 2202000477 2202000478 2202000479 2202000480 2202000481 2202000482 2202000483 2202000484 2202000485 2202000487 2202000488 2202000489 2202000490 2202000491 2202000492 2202000797 2202000798 2202000799 2202000800 2202000801 2202000802 2202000803 2202000804 2202000805 2202000806 2202000807 2202000808 2202000809 2202000810 2202000811 2202000812 2202000813 2202000814 2202000815 2202000816 2202000817 2202000819 2202000820 2202000821 2202000822 2202000823 2202000824 2202000825 2202000826 2202001299 2202001300 2202001301 2202001302 2202001303 2202001304 2202001305 2202001306 2202001307 2202001308 2202001309 220200…
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-2130-2023 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.