Max Mobility expands worldwide recall of SpeedControl Dial for SmartDrive MX2

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Sara Brenner, Acting Commissioner of Food and Drugs | U.S. Food and Drug Administration

Max Mobility expands worldwide recall of SpeedControl Dial for SmartDrive MX2

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Max Mobility/Permobil has announced a worldwide expanded recall and removal of all SpeedControl Dials used with the SmartDrive MX2+ Power Assist Device, citing safety and performance concerns. This action applies to every SpeedControl Dial manufactured and distributed between April 25, 2022, and July 8, 2025.

The company had previously issued a Class I recall for certain SpeedControl Dials due to a material change in the printed circuit board assembly (PCBA), affecting units made from August 17, 2023, to November 21, 2024. That recall was later broadened in March 2025 to include additional units up through March 10, 2025. In total, Max Mobility/Permobil received over seven hundred complaints about PCBA design issues in those devices. Five of those complaints involved serious injuries such as bone fractures and concussion. Details about these earlier recalls can be found on the FDA’s website: Initial Recall Notice and Expanded Recall Notice.

This latest action supersedes previous recalls by including all SpeedControl Dials currently on the market, even replacements provided under prior recalls.

Ongoing monitoring by Max Mobility/Permobil identified a design issue present since the product’s launch that could cause unexpected behavior of the SmartDrive MX2+ motor if there is an intermittent electrical connection between the dial and motor. According to the company, this could result in two main problems: continued drive (where the device does not fully stop when intended) or involuntary movement (where the motor activates without user input). The company reports it has received fifty-four complaints potentially related to this problem; two incidents resulted in serious injury involving bone fractures.

The risks associated with these failures range from minor injuries like bruises or scrapes at low speeds to more serious harm such as broken bones at higher speeds. There is also potential risk for people near users of affected wheelchairs if unintended movement occurs.

All SpeedControl Dials are affected by this issue. Users are advised to immediately stop using the SpeedControl Dial and switch to alternative control options such as a wired SwitchControl or using compatible wearable devices via app control. More information about compatible alternatives is available on Permobil’s website at SmartDrive Wearable Devices.

Distributors have been instructed to remove any SpeedControl Dials from inventory immediately.

Max Mobility/Permobil has stopped distribution of the product and will replace affected dials with alternative controls such as SwitchControl or compatible third-party accessories like Buddy Button switches. The SmartDrive MX2+ device itself is not recalled and remains usable with other approved control methods. Customers can find further details on replacement options at Recall Information Page.

The company states: “Max Mobility/Permobil is voluntarily issuing this expanded recall and removal of the SpeedControl Dial from the market, and the U.S. Food and Drug Administration has been notified of this action.”

Users experiencing adverse reactions or quality issues can report them directly to FDA’s MedWatch program online or by mail or fax following instructions on their official site.

For questions about technical support or orders related to this recall, customers are directed to contact Permobil’s support team by phone or email during regular business hours.

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