SAU1 is sharing this from the Office of Developmental Programs (ODP). ODP is sharing this important announcement from the U. S. Food and Drug Administration (FDA).

U.S. Food and Drug Administration Product Recall Alert!

The SmartDrive Speed Control Dial by Max Mobility/Permobil: Recall Expansion - Due to the Motor Being Unresponsive to the User.

Summary

• Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns.
• This frame-mounted Speed Control Dial can be easily mounted to a wheelchair to allow for close access and easy pressing.
• The recall was originally initiated on December 20, 2024, and has been expanded to address recalled product that may have been inadvertently comingled with redesigned product and shipped after December 20, 2024.
• Those impacted by the expansion of the recall will be contacted with additional instructions.
• This recall, as expanded, impacts all Speed Control Dials manufactured and distributed between the dates of August 17, 2023, through March 10, 2025.
• As of March 27, 2025, Max Mobility/Permobil has received 781 complaints associated with the Speed Control Dial. As of March 27, 2025, five (5) serious injuries have been reported for this issue.

• The reported serious injuries include a fractured hip, fractured tibia, fractured malleolus bone, broken ribs, and a concussion.

BACKGROUND

Max Mobility/Permobil Brand – (model number: MX2-3DCK/MX2-3DC) - The frame-mounted Speed Control is easily mounted to a wheelchair to allow for close access and easy pressing. The Speed Control Dial can be used to deactivate the SmartDrive motor, as well as provide a means of actively powering the motor.

RECOMMENDATIONS

To reduce the likelihood of a hazardous situation, discontinue use of the Speed Control Dial and utilize an alternate wired controller (Switch Control buttons or Switch Control with mono jack and mechanical switch) or wearable controller (compatible Apple Watch or Samsung Galaxy Watch Wear OS app).

If you have purchased a Speed Control Dial(s) with the above model numbers, you will need to request replacement Speed Control Dial units.

Refer to the FDA Original Press Release at Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User | FDA for instruction on requesting a replacement and additional information.