Class I U.S. Food and Drug Administration

WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05 recall: Cyber vulnerability of BLE communication was found by CISA VDP program

Recall published 6 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Cyber vulnerability of BLE communication was found by CISA VDP program.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1827-2026
Published
May 6, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Whill, Inc.
Product type
Medical devices
Units affected
2324 units
Distribution
Kansas
Made in
Japan
Lot / code info
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, FB1203U2610101, FB1203U2610100, FB1203U2610099, FB1203U2610098, FB1203U2610097, FB1203U2610096, FB1203U2610095, FB1203U2610094, FB1203U2610093, FB1203U2610092, FB1203U2610091, FB1203U2610090, FB1203U2610089, FB1203U2610088, FB1203U2610087, FB1203U2610086, FB1203U2610085, FB1203U2610084, FB1203U2610083, FB1203U2610082, FB1203U2610081, FB1203U2610080, FB1203U2610079, FB1203U2610078, FB1203U2610077, FB1203U2610076, FB1203U2610075, FB1203U2610074, FB1203U2610073, FB1203U2610072, FB1203U2610071, FB1203U2610070, FB1203U2610069, FB1203U2610068, FB1203U2610067, FB1203U2610066, FB1203U2610065, FB1203U2610064, FB1203U2610063, FB1203U2610062, FB1203U2610061, FB1203U2610060, FB1203U2610059, FB1203U2610058, FB1203U2610057, FB1203U2610056, FB1203U2610055, FB1203U2610054, FB1203U2610053, FB1203U2610052, FB1203U2610051, FB1203U2610050, FB1203U2610049, FB1203U2610048, FB1203U2610047, FB1203U2610046, FB1203U2610045, FB1203U2610044, FB1203U2610043, FB1203U2610042, FB1203U2610041, FB1203U2610040, FB1203U2610039, FB1203U2610038, FB1203U2610037, FB1203U2610036, FB1203U2610035, FB1203U2610034, FB1203U2610033, FB1203U2610032, FB1203U2610031, FB1203U2610030, FB1203U2610029, FB1203U2610028, FB1203U2610027, FB1203U2610026, FB1203U2610025, FB1203U2610024, FB1203U2610023, FB1203U2610022, FB1203U2610021, FB1203U2610020, FB1203U2610019, FB1203U2610018, FB1203U2610017, FB1203U2610016, FB1203U2610015, FB1203U2610014, FB1203U2610013, FB1203U2610012, FB1203U2610011, FB1203U2610010, FB1203U2610009, FB1203U2610008, FB1203U2610007, FB1203U2610006, FB1203U2610005, FB1203U2610004, FB1203U2610003, FB1203U2610002, FB1203U2610001, FB1203U2590192, FB1203U2590191, FB1203U2590190, FB1203U2590189, FB1203U2590188, FB1203U2590187, FB1203U2590186, FB1203U2590185, FB1203U2590184, FB1203U2590183, FB1203U2590182, FB1203U2590181, FB1203U2590180, FB1203U2590179, FB1203U2590178, FB1203U2590177, FB1203U2590176, FB1203U2590175, FB1203U2590174, FB1203U2590173, FB1203U2590172, FB1203U2590171, FB1203U2590170, FB1203U2590169, FB1203U2590168, FB1203U2590167, FB1203U2590166, FB1203U2590165, FB1203U2590164, FB1203U2590163, FB1203U2590162, FB1203U2590161, FB1203U2590160, FB1203U2590159, FB1203U2590158, FB1203U2590157, FB1203U2590156, FB1203U2590155, FB1203U2590154, FB1203U2590153, FB1203U2590152, FB1203U2590151, FB1203U2590150, FB1203U2590149, FB1203U2590148, FB1203U2590147, FB1203U2590146, FB1203U2590145, FB1203U2590144, FB1203U2590143, FB1203U2590142, FB1203U2590141, FB1203U2590140, FB1203U2590139, FB1203U2590138, FB1203U2…
UPC codes
04570072300019

Products covered by this recall

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.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04570072300019

Serial number

On the rating plate, often next to the date of manufacture.

  • FB1203U2610192
  • FB1203U2610191
  • FB1203U26

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Whill, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: WHILL, INC. — 2 Chome 1-11, Shinagawa

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Whill, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04570072300019. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists Kansas.

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