FDA Medical devices recall ·
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1827-2026
- 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
- 2324 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
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: FB1203U2610192, FB1203U2610191, FB1203U2610190, FB1203U2610189, FB1203U2610188, FB1203U2610187, FB1203U2610186, FB1203U2610185, FB1203U2610184, FB1203U2610183, FB1203U2610182, FB1203U2610181, FB1203U2610180, FB1203U2610179, FB1203U2610178, FB1203U2610177, FB1203U2610176, FB1203U2610175, FB1203U2610174, FB1203U2610173, FB1203U2610172, FB1203U2610171, FB1203U2610170, FB1203U2610169, FB1203U2610168, FB1203U2610167, FB1203U2610166, FB1203U2610165, FB1203U2610164, FB1203U2610163, FB1203U2610162, FB1203U2610161, FB1203U2610160, FB1203U2610159, FB1203U2610158, FB1203U2610157, FB1203U2610156, FB1203U2610155, FB1203U2610154, FB1203U2610153, FB1203U2610152, FB1203U2610151, FB1203U2610150, FB1203U2610149, FB1203U2610148, FB1203U2610147, FB1203U2610146, FB1203U2610145, FB1203U2610144, FB1203U2610143, FB1203U2610142, FB1203U2610141, FB1203U2610140, FB1203U2610139, FB1203U2610138, FB1203U2610137, FB1203U2610136, FB1203U2610135, FB1203U2610134, FB1203U2610133, FB1203U2610132, FB1203U2610131, FB1203U2610130, FB1203U2610129, FB1203U2610128, FB1203U2610127, FB1203U2610126, FB1203U2610125, FB1203U2610124, FB1203U2610123, FB1203U2610122, FB1203U2610121, FB1203U2610120, FB1203U2610119, FB1203U2610118, FB1203U2610117, FB1203U2610116, FB1203U2610115, FB1203U2610114, FB1203U2610113, FB1203U2610112, FB1203U2610111, FB1203U2610110, FB1203U2610109, FB1203U2610108, FB1203U2610107, FB1203U2610106, FB1203U2610105, FB1203U2610104, FB1203U2610103, FB1203U2610102, FB120
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-1827-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.