FDA Recall Open, Classified

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.

Recall: Z-1826-2026 · Initiated December 29, 2025

Recall

Recall Number
Z-1826-2026
Event Number
98320
Firm
WHILL, INC. 2 Chome 1-11 Higashishinagawa Shinagawa Japan
FEI Number
3021071770
Product Code
ITI
Status
Open, Classified
Root Cause
Device Design
Initiated
December 29, 2025
Posted
April 24, 2026

Description

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.

Action

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: [email protected] or Phone: 844-699-4455. The firm has also posted the notice on their website: https://whill.inc/us/voluntary-safety-notice/

Distribution

US: Kansas

Quantity

4685 units