Recall Z-1826-2026
Whill, Inc. · initiated December 29, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
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, CB2107U25A0081, CB2107U25A0080, CB2107U25A0079, CB2107U25A0078, CB2107U25A0077, CB2107U25A0076, CB2107U25A0075, CB2107U25A0074, CB2107U25A0073, CB2107U25A0072, CB2107U25A0071, CB2107U25A0070, CB2107U25A0069, CB2107U25A0068, CB2107U25A0067, CB2307U2580068, CB2307U2580067, CB2307U2580066, CB2307U2580065…
Reason for recall
Cyber vulnerability of BLE communication was found by CISA VDP program.
FDA-determined cause: Device Design
Action taken
Whill, Inc. issued a Medical Device Recall notice to its sole consignee on 3/23/2026 via email. The notice explained the issue, risks to health, and how to recognize the failure of the device. The notice also provided the following instructions for the distributor: Actions to be taken by the Distributor: 1. Cease all distribution of the devices until the corrective firmware update (2.24 for Model C2 and 2.25 for Model F) has been successfully installed. 2. Notify all customers with previous versions of Model C2 and Model F firmware of this issue. You may use this notice with the User Response Form. 3. Complete the attached response form and return it to XXX." The actions to be taken by the user include explicit instructions on how to disable the Bluetooth so the device may be safely operated. For questions, contact: Email: support.us@whill.inc or Phone: 844-699-4455. The firm has also posted the notice on their website: https://whill.inc/us/voluntary-safety-notice/ On 6/29/2026 Whill, Inc. issued an updated notice to its consignees, distributor and user, informing them of the availability of the updated firmware to correct the device with detailed instructions on installation. The firm also placed a copy of the notice on its website.
Details
- Recall number
- Z-1826-2026
- Initiated
- December 29, 2025
- Posted by FDA
- April 24, 2026
- Product code
- ITI – Wheelchair, Powered
- Quantity
- 4685 units
- Distribution
- US: Kansas
- Recalling firm
- Whill, Inc., shinagawa, 2 Chome
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1827-2026 Class I | WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an…Cyber vulnerability of BLE communication was found by CISA VDP program. | 12/29/2025Open, Classified |