FDA Medical devices recall ·
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1826-2026
- Date
- (initiated December 29, 2025)
- Company / brand
- Whill, Inc.
2 Chome 1-11, Shinagawa, Japan - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 4685 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
Why was it recalled?
Cyber vulnerability of BLE communication was found by CISA VDP program.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 04570072300019, Serial Numbers: CB2307U25A0134, CB2307U25A0133, CB2307U25A0132, CB2307U25A0131, CB2307U25A0130, CB2307U25A0129, CB2307U25A0128, CB2307U25A0127, CB2307U25A0126, CB2307U25A0125, CB2307U25A0124, CB2307U25A0123, CB2307U25A0122, CB2307U25A0121, CB2307U25A0120, CB2307U25A0119, CB2307U25A0118, CB2307U25A0117, CB2307U25A0116, CB2307U25A0115, CB2207U25A0114, CB2207U25A0113, CB2207U25A0112, CB2207U25A0111, CB2207U25A0110, CB2207U25A0109, CB2207U25A0108, CB2207U25A0107, CB2207U25A0106, CB2207U25A0105, CB2207U25A0104, CB2207U25A0103, CB2207U25A0102, CB2207U25A0101, CB2207U25A0100, CB2207U25A0099, CB2207U25A0098, CB2207U25A0097, CB2207U25A0096, CB2207U25A0095, CB2207U25A0094, CB2207U25A0093, CB2207U25A0092, CB2207U25A0091, CB2207U25A0090, CB2207U25A0089, CB2207U25A0088, CB2207U25A0087, CB2107U25A0086, CB2107U25A0085, CB2107U25A0084, CB2107U25A0083, CB2107U25A0082, CB2107U25A0081, CB2107U25A0080, CB2107U25A0079, CB2107U25A0078, CB2107U25A0077, CB2107U25A0076, CB2107U25A0075, CB2107U25A0074, CB2107U25A0073, CB2107U25A0072, CB2107U25A0071, CB2107U25A0070, CB2107U25A0069, CB2107U25A0068, CB2107U25A0067, CB2307U2580068, CB2307U2580067, CB2307U2580066, CB2307U2580065, CB2307U2580064, CB2307U2580063, CB2307U2580062, CB2307U2580061, CB2307U2580060, CB2307U2580059, CB2307U2580058, CB2307U2580057, CB2307U2580056, CB2307U2580055, CB2307U2580054, CB2307U2580053, CB2307U2580052, CB2307U2580051, CB2307U2580050, CB2307U2580049, CB2307U2580048, CB2307U2580047, CB2307U2580046, CB230
Distribution
US: Kansas
States: Kansas
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1826-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.