WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel

FDA device recall Z-1826-2026 · posted 2026-04-24 · Open, Classified

Recall details

Recalling firm

WHILL, INC.

Reason for recall

Cyber vulnerability of BLE communication was found by CISA VDP program.

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.

Root cause

Device Design

Status

Open, Classified

Product code

ITI

Quantity affected

4685 units

Distribution

US: Kansas

Date initiated

2025-12-29

Date posted

2026-04-24

Location

shinagawa, 2 Chome, Japan

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