FDA Medical devices recall ·
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control… recall
- Recall number
- Z-2856-2026
- Date
- (initiated June 19, 2026)
- Company / brand
- Munevo Gmbh
Agnes-Pockels-Bogen 1, Munich, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 19
- Hazard tags
- Software Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
Why was it recalled?
A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.
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
Affected software versions: munevo DRIVE v1: 10.14.5 - 12.0.4; munevo DRIVE R-net: 10.17.5. - 12.0.4 UDI-DI 04260691380010 Units with affected features enabled: 2QNTGG2820170029, 2QNTGG2820170047, 2QNTGG2820160730, 2QNTGG2820161031, 1QNTGG2519120215, 1QNTGG2818520491, 1QNTGG2819210671, 2QNTGG2820160358, 2QNTGG2820170527, 2QNTGG2820160265, 2QNTGG2820160732, 1QNTGG2819200073, 2QNTGG2820160746, 2QNTGG2820160410, 2QNTGG2820160500, 2QNTGG2820160368, 2QNTGG2820161091, 2QNTGG2820161026, 2QNTGG2820160699
Distribution
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.
States: California Florida North Carolina Texas Utah Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2856-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.