WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
type: Dataset
description: FDA recall Z-1826-2026 — WHILL, INC. is recalling WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor 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 C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
  type: MedicalDevice
  manufacturer: WHILL, INC.
claims: enforcement-record
claims: FDA classified recall Z-1826-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1826-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1826-2026
      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: CB2307U25A0134, CB2307U25A0133, CB2307U25A0132, CB2307U25A0131, CB2307U25A0130, CB2307U25A0129, CB2307U25A0128, CB2307U25A0127, CB2307U25A0126, CB2307U25A0125, CB2307U25A0124, CB2307U25A0123, CB2307U25A0122, CB2307U25A0121, CB2307U25A0120, CB2307U25A0119, CB2307U25A0118, CB2307U25A0117, CB2307U25A0116, CB2307U25A0115, CB2207U25A0114, CB2207U25A0113, CB2207U25A0112, CB2207U25A0111, CB2207U25A0110, CB2207U25A0109, CB2207U25A0108, CB2207U25A0107, CB2207U25A0106, CB2207U25A0105, CB2207U25A0104, CB2207U25A0103, CB2207U25A0102, CB2207U25A0101, CB2207U25A0100, CB2207U25A0099, CB2207U25A0098, CB2207U25A0097, CB2207U25A0096, CB2207U25A0095, CB2207U25A0094, CB2207U25A0093, CB2207U25A0092, CB2207U25A0091, CB2207U25A0090, CB2207U25A0089, CB2207U25A0088, CB2207U25A0087, CB2107U25A0086, CB2107U25A0085, CB2107U25A0084, CB2107U25A0083, CB2107U25A0082, CB2107U25A0081, CB2107U25A0080, CB2107U25A0079, CB2107U25A0078, CB2107U25A0077, CB2107U25A0076, CB2107U25A0075, CB2107U25A0074, CB2107U25A0073, CB2107U25A0072, CB2107U25A0071, CB2107U25A0070, CB2107U25A0069, CB2107U25A0068, CB2107U25A0067, CB2307U2580068, CB2307U2580067, CB2307U2580066, CB2307U2580065, CB2307U2580064, CB2307U2580063, CB2307U2580062, CB2307U2580061, CB2307U2580060, CB2307U2580059, CB2307U2580058, CB2307U2580057, CB2307U2580056, CB2307U2580055, CB2307U2580054, CB2307U2580053, CB2307U2580052, CB2307U2580051, CB2307U2580050, CB2307U2580049, CB2307U2580048, CB2307U2580047, CB2307U2580046, CB2307U2580045, CB2307U2580044, CB2307U2580043, CB2307U2580042, CB2307U2580041, CB2307U2580040, CB2307U2580039, CB2307U2580038, CB2307U2580037, CB2307U2580036, CB2307U2580035, CB2307U2580034, CB2307U2580033, CB2307U2580032, CB2307U2580031, CB2207U2580030, CB2207U2580029, CB2207U2580028, CB2207U2580027, CB2207U2580026, CB2207U2580025, CB2207U2580024, CB2207U2580023, CB2207U2580022, CB2207U2580021, CB2207U2580020, CB2207U2580019, CB2207U2580018, CB2207U2580017, CB2207U2580016, CB2207U2580015, CB2207U25…
      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-1826-2026: WHILL, INC. is recalling WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
text: The FDA logged enforcement record Z-1826-2026: WHILL, INC. is voluntarily recalling WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor 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: CB2307U25A0134, CB2307U25A0133, CB2307U25A0132, CB2307U25A0131, CB2307U25A0130, CB2307U25A0129, CB2307U25A0128, CB2307U25A0127, CB2307U25A0126, CB2307U25A0125, CB2307U25A0124, CB2307U25A0123, CB2307U25A0122, CB2307U25A0121, CB2307U25A0120, CB2307U25A0119, CB2307U25A0118, CB2307U25A0117, CB2307U25A0116, CB2307U25A0115, CB2207U25A0114, CB2207U25A0113, CB2207U25A0112, CB2207U25A0111, CB2207U25A0110, CB2207U25A0109, CB2207U25A0108, CB2207U25A0107, CB2207U25A0106, CB2207U25A0105, CB2207U25A0104, CB2207U25A0103, CB2207U25A0102, CB2207U25A0101, CB2207U25A0100, CB2207U25A0099, CB2207U25A0098, CB2207U25A0097, CB2207U25A0096, CB2207U25A0095, CB2207U25A0094, CB2207U25A0093, CB2207U25A0092, CB2207U25A0091, CB2207U25A0090, CB2207U25A0089, CB2207U25A0088, CB2207U25A0087, CB2107U25A0086, CB2107U25A0085, CB2107U25A0084, CB2107U25A0083, CB2107U25A0082, CB2107U25A0081, CB2107U25A0080, CB2107U25A0079, CB2107U25A0078, CB2107U25A0077, CB2107U25A0076, CB2107U25A0075, CB2107U25A0074, CB2107U25A0073, CB2107U25A0072, CB2107U25A0071, CB2107U25A0070, CB2107U25A0069, CB2107U25A0068, CB2107U25A0067, CB2307U2580068, CB2307U2580067, CB2307U2580066, CB2307U2580065, CB2307U2580064, CB2307U2580063, CB2307U2580062, CB2307U2580061, CB2307U2580060, CB2307U2580059, CB2307U2580058, CB2307U2580057, CB2307U2580056, CB2307U2580055, CB2307U2580054, CB2307U2580053, CB2307U2580052, CB2307U2580051, CB2307U2580050, CB2307U2580049, CB2307U2580048, CB2307U2580047, CB2307U2580046, CB2307U2580045, CB2307U2580044, CB2307U2580043, CB2307U2580042, CB2307U…
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-1826-2026 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.