WHILL, INC.

FDA Regulatory Profile

WHILL, INC. appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1826-2026, Class I) was initiated on December 29, 2025. Its most recent 510(k) clearance was granted on June 12, 2026.

Summary

Total Recalls
2 (2 Class I)
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1826-2026Class IWHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battDecember 29, 2025
Z-1827-2026Class IWHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, December 29, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K261175WHILL (WHILL Model C2)June 12, 2026
K242760WHILL Model RJanuary 6, 2025
K221438WHILL Model FJune 7, 2022
K213383WHILL Model C2November 9, 2021
K153543WHILL Model MFebruary 12, 2016