Medical device recalls High risk

WHILL, INC. recalls WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-op…

Recall date
December 29, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1827-2026
FDA classification
Class I
Brand / firm
WHILL, INC.
Sold / distributed
US: Kansas

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.

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