ClearanceBrief
Recall Z-1827-2026 ยท ITI Wheelchair, Powered

WHILL, INC.

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.

DateApr 24, 2026 (initiated Dec 29, 2025)
StatusOpen, Classified
ReasonCyber vulnerability of BLE communication was found by CISA VDP program.
Root causeDevice Design
ActionWhill, 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 Respo
Quantity2324 units
DistributionUS: Kansas
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K221438WHILL Model F
Whill, Inc., Jun 7, 2022