Skip to main content

Ongoing FDAEvent 99328 (2 months ago)

Munevo DRIVE and Munevo DRIVE R-Net Powered Wheelchair Hands-Free Control Application

A software issue may cause the wheelchair's driving mechanism to fall out of calibration, leading to unexpected steering drift or imprecise control.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Munevo GMBH, of Munich, Germany, began a recall of its Munevo DRIVE and Munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System on June 19, 2026, due to a software issue that may cause the driving mechanism to fall out of calibration.

This may result in unexpected steering drift or imprecise control while driving, potentially leading to low-speed collision, tipping, or injuries to users or bystanders. The FDA added the recall to its Enforcement Report on July 31, 2026.

The product was distributed in California, Florida, North Carolina, Texas, Utah, and Washington, as well as the United Kingdom, Spain, Italy, Germany, and Switzerland.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its UDI-DI matches.

  1. munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System

    UDI-DI
    • 04260691380010

Details

Company began the recall
Sold in

Worldwide - US Nationwide distribution in the states of California, Florida, North Carolina, Texas, Utah, and Washington. The countries of United Kingdom, Spain, Italy, Germany, and Switzerland.

Event ID
99328
Recall No.
Z-2856-2026
Company
MUNEVO GMBHMunich, Germany
Recall type
Voluntary: Firm initiated
Customers told by
Letter
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration