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.
FDA Recall Z-1827-2026 · Posted 2026-04-24
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Recalling FirmWHILL, INC.
Recall StatusOpen, Classified
Product CodeITI
Date Initiated2025-12-29
Product Quantity2324 units
Reason for Recall
Cyber vulnerability of BLE communication was found by CISA VDP program.
Firm 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/
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
Distribution Pattern
US: Kansas
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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