Whill, Inc. medical device recall: WHILL Model C2
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98320
- Recall initiated
- Dec 29, 2025
- Classified by FDA
- Apr 24, 2026
- Posted in Enforcement Report
- May 6, 2026
- Recalling firm
- WHILL, INC.
- Firm location
- Shinagawa, Japan
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Cyber vulnerability of BLE communication was found by CISA VDP program.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Dec 29, 2025. FDA classified it 116 days later, on Apr 24, 2026. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: US: Kansas WHILL, INC. has 2 recalls in our records.
Recalled products (2)
Z-1826-2026 Class I Ongoing
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.
Codes / lots: 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,…
Quantity: 4685 units
Z-1827-2026 Class I Ongoing
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.
Codes / lots: 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,…
Quantity: 2324 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98320
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.