WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
type: Dataset
description: FDA recall Z-1827-2026 — WHILL, INC. is recalling WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. (Devices, Class I). 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: WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
  type: MedicalDevice
  manufacturer: WHILL, INC.
claims: enforcement-record
claims: FDA classified recall Z-1827-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1827-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1827-2026
      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 I
      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: WHILL, INC.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Cyber vulnerability of BLE communication was found by CISA VDP program.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-12-29
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI/DI 04570072300019, Serial Numbers: FB1203U2610192, FB1203U2610191, FB1203U2610190, FB1203U2610189, FB1203U2610188, FB1203U2610187, FB1203U2610186, FB1203U2610185, FB1203U2610184, FB1203U2610183, FB1203U2610182, FB1203U2610181, FB1203U2610180, FB1203U2610179, FB1203U2610178, FB1203U2610177, FB1203U2610176, FB1203U2610175, FB1203U2610174, FB1203U2610173, FB1203U2610172, FB1203U2610171, FB1203U2610170, FB1203U2610169, FB1203U2610168, FB1203U2610167, FB1203U2610166, FB1203U2610165, FB1203U2610164, FB1203U2610163, FB1203U2610162, FB1203U2610161, FB1203U2610160, FB1203U2610159, FB1203U2610158, FB1203U2610157, FB1203U2610156, FB1203U2610155, FB1203U2610154, FB1203U2610153, FB1203U2610152, FB1203U2610151, FB1203U2610150, FB1203U2610149, FB1203U2610148, FB1203U2610147, FB1203U2610146, FB1203U2610145, FB1203U2610144, FB1203U2610143, FB1203U2610142, FB1203U2610141, FB1203U2610140, FB1203U2610139, FB1203U2610138, FB1203U2610137, FB1203U2610136, FB1203U2610135, FB1203U2610134, FB1203U2610133, FB1203U2610132, FB1203U2610131, FB1203U2610130, FB1203U2610129, FB1203U2610128, FB1203U2610127, FB1203U2610126, FB1203U2610125, FB1203U2610124, FB1203U2610123, FB1203U2610122, FB1203U2610121, FB1203U2610120, FB1203U2610119, FB1203U2610118, FB1203U2610117, FB1203U2610116, FB1203U2610115, FB1203U2610114, FB1203U2610113, FB1203U2610112, FB1203U2610111, FB1203U2610110, FB1203U2610109, FB1203U2610108, FB1203U2610107, FB1203U2610106, FB1203U2610105, FB1203U2610104, FB1203U2610103, FB1203U2610102, FB1203U2610101, FB1203U2610100, FB1203U2610099, FB1203U2610098, FB1203U2610097, FB1203U2610096, FB1203U2610095, FB1203U2610094, FB1203U2610093, FB1203U2610092, FB1203U2610091, FB1203U2610090, FB1203U2610089, FB1203U2610088, FB1203U2610087, FB1203U2610086, FB1203U2610085, FB1203U2610084, FB1203U2610083, FB1203U2610082, FB1203U2610081, FB1203U2610080, FB1203U2610079, FB1203U2610078, FB1203U2610077, FB1203U2610076, FB1203U2610075, FB1203U2610074, FB1203U2610073, FB1203U2610072, FB1203U2610071, FB1203U26…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US: Kansas
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1827-2026: WHILL, INC. is recalling WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
text: The FDA logged enforcement record Z-1827-2026: WHILL, INC. is voluntarily recalling WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. — reason: Cyber vulnerability of BLE communication was found by CISA VDP program.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-29. Affected lots/codes: UDI/DI 04570072300019, Serial Numbers: FB1203U2610192, FB1203U2610191, FB1203U2610190, FB1203U2610189, FB1203U2610188, FB1203U2610187, FB1203U2610186, FB1203U2610185, FB1203U2610184, FB1203U2610183, FB1203U2610182, FB1203U2610181, FB1203U2610180, FB1203U2610179, FB1203U2610178, FB1203U2610177, FB1203U2610176, FB1203U2610175, FB1203U2610174, FB1203U2610173, FB1203U2610172, FB1203U2610171, FB1203U2610170, FB1203U2610169, FB1203U2610168, FB1203U2610167, FB1203U2610166, FB1203U2610165, FB1203U2610164, FB1203U2610163, FB1203U2610162, FB1203U2610161, FB1203U2610160, FB1203U2610159, FB1203U2610158, FB1203U2610157, FB1203U2610156, FB1203U2610155, FB1203U2610154, FB1203U2610153, FB1203U2610152, FB1203U2610151, FB1203U2610150, FB1203U2610149, FB1203U2610148, FB1203U2610147, FB1203U2610146, FB1203U2610145, FB1203U2610144, FB1203U2610143, FB1203U2610142, FB1203U2610141, FB1203U2610140, FB1203U2610139, FB1203U2610138, FB1203U2610137, FB1203U2610136, FB1203U2610135, FB1203U2610134, FB1203U2610133, FB1203U2610132, FB1203U2610131, FB1203U2610130, FB1203U2610129, FB1203U2610128, FB1203U2610127, FB1203U2610126, FB1203U2610125, FB1203U2610124, FB1203U2610123, FB1203U2610122, FB1203U2610121, FB1203U2610120, FB1203U2610119, FB1203U2610118, FB1203U2610117, FB1203U2610116, FB1203U2610115, FB1203U2610114, FB1203U2610113, FB1203U2610112, FB1203U2610111, FB1203U2610110, FB1203U2610109, FB1203U2610108, FB1203U2610107, FB1203U2610106, FB1203U2610105, FB1203U2610104, FB1203U2610103, FB1203U2610102, FB1203U2610101, FB1203U2610100, FB1203U2610099, FB1203U261…
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-1827-2026 as Class I
type: Claim
text: The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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 I
  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.