Almost 12,000 Parts of a Widely Used Medical Device Recalled at the Highest National Risk Level

Today it may feel like concerns are looming for persons with disabilities and their rights and access. In 2024, the U.S. Department of Transportation shared data suggesting 5.5 million Americans used wheelchairs last year.

If you’re one of them or care for someone who is, the FDA recently updated a recall for more than 11,000 wheelchair devices meant to allow users greater mobility and control over speed.

The initial recall press release announced a voluntary nationwide recall of Max Mobility/Permobil’s SpeedControl Dial, stating “potential safety and performance concerns.” The SpeedControl Dial is intended to provide manual wheelchairs with an option to easily start, stop, and adjust their wheelchair’s speed. The dial—manufactured by Max Mobility, operating in Lebanon, TN—is used with the SmartDrive MX2+ Power Assist Device.

That advisory, reportedly first announced on January 14, listed potentially serious malfunctions such as “involuntary movement,” “loss of power,” and “continued drive.” The FDA revealed that 646 complaints had been filed in connecting with SpeedControl Dial issues as of December 12, 2024. Several types of potential injury concerns were listed, ranging from minor cuts and bruises to concussions or bone fractures. Additionally, three serious injuries had been reported at that time, including “a fractured hip, fractured tibia, and fractured malleolus bone,” or ankle.

On February 11, the FDA issued an update, now labelling the event as a Class I recall—the highest risk level associated with recalls. A Class I designation is “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death,” as defined by the FDA.

The updated FDA recall notice warns: “Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, [there] is a potential for [loss] of control of device[,] potentially resulting in minor and major injuries.”

The company Permobil produces products to aid wheelchair users, including power and manual wheelchairs, seating and support, and power assist devices. The company has a dedicated website page answering several frequently asked questions about the recall. The page states they have identified the issue as “a material change with the printed circuit board assembly (PCBA) in the SpeedControl Dial resulting in inconsistent performance issues. The recall strategy will provide a redesigned SpeedControl Dial to address these intermittent performance issues on any new orders, as well as units already in the field.”

The recall affects 11,891 total units, and the FDA notice says all SpeedControl Dial serial numbers that were manufactured between August 17, 2023 and November 21, 2024, with model numbers MX2-3DCK/MX2-3DC, are included in the recall. The Permobil website shows users how to check their devices for the serial number, which is found under the “front nose” of the SmartDrive device. It should be noted that the SmartDrive power assist devices, where the serial numbers are found, are not being recalled—the recalled SpeedControl Dials are “a wired control option for SmartDrive.”

The initial notice added that the recalled products were distributed “through authorized dealers for purchase by consumers” nationwide in the U.S., in addition to several international countries such as Canada, Mexico, and Australia.