Class I U.S. Food and Drug Administration

Max Mobility/Permobil Speed Control Dial Component recall: Due to potential safety and performance concerns

Recall published 1+ years ago Last updated

Due to potential safety and performance concerns

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Of these complaints, five (5) were for serious injuries, involving fractured or broken bones and a concussion.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2538-2025, Z-2539-2025, Z-2540-2025
Published
January 14, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Max Mobility/Permobil
Product type
Medical devices
Units affected
25,389 units; 15,834 units; 8,413 units
Distribution
Connecticut
Lot / code info
All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025
Reports of harm
As of March 27, 2025, five (5) serious injuries have been reported for this issue.

Products covered by this recall

Speed Control Dial Component

What the company announced

Max Mobility/Permobil has voluntarily expanded its recall of the SpeedControl Dial, a wired control option for the SmartDrive MX2+ Power Assist Device, due to safety and performance concerns. This voluntary action applies to all SpeedControl Dials manufactured and distributed between the dates of April 25, 2022 to July 08, 2025.

Relation to Existing/Prior Recall:

A Class I recall (Z-1116-2025, Z-1117-2025), RES # 96086 was originally initiated on December 20, 2024 to address a material change with the printed circuit board assembly (PCBA) in SpeedControl Dials manufactured and distributed between the dates of August 17, 2023 and November 21, 2024. The recall was later expanded on March 28, 2025, and included all units manufactured and distributed from August 17, 2023 up to March 10, 2025. Max Mobility/Permobil received 781 complaints associated with PCBA design. Of these complaints, five (5) were for serious injuries, involving fractured or broken bones and a concussion. Information about prior recalls can be found using the following links:

Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User | FDA

Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User | FDA

This new expanded recall supersedes the previous recall and applies to all SpeedControl Dials in the market, including replacements received under the previous recall.

Reason for Expanded Voluntary Field Removal:

Through ongoing complaint monitoring and subsequent investigation, Max Mobility/Permobil identified a design issue with the SpeedControl Dial that may lead to unexpected behavior of the SmartDrive MX2+ motor. This design issue has been part of the SpeedControl Dial since it was first introduced to the market in April 2022 and impacts all SpeedControl Dials manufactured and distributed, which occurred between April 25, 2022 to July 08, 2025, if there is an intermittent electrical connection between the SpeedControl Dial and SmartDrive MX2+ motor, the following performance issues could occur:

Continued drive: The SmartDrive MX2+ Power Assist Device fails to fully stop when the SpeedControl Dial is pressed inward.

Involuntary movement: Unintended activation of the SmartDrive MX2+ motor without intentional user input to the SpeedControl Dial while the dial is at zero position and dial light is flashing in stand-by-mode.

Max Mobility/Permobil has identified 54 complaints that may be associated with this issue. Of these complaints, two (2) involve serious injuries related to bone fractures.

Risk to Health:

If an individual is using a Max Mobility/Permobil SpeedControl Dial to control their SmartDrive MX2+ Power Assist Device and experiences one of the performance concerns identified above, they may experience continued drive and/or involuntary movement. Depending on the scenario, this could lead to minor and/or serious injuries. A minor injury, such as a cut, bruise, scrape, or general soreness, could occur if one of these scenarios occurs at a low overall speed. If a user is travelling at a fast rate of speed and one of these scenarios occurs, there is a potential for serious injury, such as a bone fracture.

There is also a potential risk associated with individuals who may be in close proximity to a user of a SpeedControl Dial if one of these performance failure scenarios were to occur, as the wheelchair powered by the SmartDrive MX2+ Power Assist Device could run or bump into another individual and/or roll over their toes or another extremity.

Affected Product:

All SpeedControl Dials are impacted by this issue. Specific part numbers associated with SpeedControl Dials are shown below:

  • Part Number: MX2-3DCK
  • Part Number: MX2-3DC
  • Part Number: MX2-3DCMC

Actions Required if you are an End User:

Immediately discontinue use of the SpeedControl dial to reduce the likelihood of a potentially hazardous or harmful situation.

Use an alternate method to control the SmartDrive MX2+ Power Assist Device. Alternate controls include: A wired SwitchControl, which can be ordered with a mono jack port to connect with an optional Buddy Button

Wirelessly through the SmartDrive MX2+ App utilizing a Apple iWatch or Samsung Galaxy watch. A list of compatible wearable devices can be found at: https://www.permobil.com/en-us/products/power-assist/smartdrive-mx2plus-premium-wearables

Please click here to visit our website for additional instructions.

Actions Required if you are a Distributor:

If you possess or distributed a SpeedControl Dial, please take the following actions immediately:

Since all SpeedControl Dials are impacted by this recall, remove SpeedControl Dials from your sellable / distribution inventory.

Please click here to visit our website for additional instructions.

Actions planned by Max Mobility/Permobil to correct the problem:

Max Mobility/Permobil has suspended distribution of the SpeedControl Dial, and the SpeedControl Dial is no longer an available control option for the SmartDrive MX2+ Power Assist Device. However, the SmartDrive MX2+ Power Assist Device is not impacted by this recall and can still be used with alternative control options.

Max Mobility/Permobil will replace SpeedControl Dials with an alternate control. The wired SwitchControl can be ordered with a mono jack port to connect with an optional Buddy Button. The Buddy Button is a third-party accessory option, provided by through Permobil, which is a switch that provides further tactile feedback and is larger than our standard SwitchControl. The SmartDrive MX2+ Power Assist Device can also be controlled via an App using a wearable device. Please visit our website click here to learn more about the available alternative control options for the SmartDrive MX2+ Power Assist Device. If users are unsure which controller is best for them, we recommend that users reach out to their SmartDrive provider and/or healthcare provider. https://hub.permobil.com/max-mobility/permobil-speedcontrol-dial-recall?hs_preview=pqVrhaIZ-192777234330 . A notification will be sent to all customers starting on August 12, 2025.

Contact Information:

If you require assistance or have further inquiries regarding this voluntary recall, please communicate with our Technical Support Team at 615-257-2930 for technical assistance. For order inquiries, please contact Max Mobility/Permobil at 1-800-736-0925 ext. 6 or by email at [email protected] . The Support Team is available Monday - Friday from 8:00 am CT to 5:00 pm CT.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s Medwatch Adverse Event Reporting program using one of the following options:

Online: By completing and submitting the report online at https://www.accessdata.fda.gov/scripts/medwatch

Regular mail or Fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit it by fax to 800-332-0178.

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.

Audra Watt, VP Marketing, Permobil Americas

Telephone: 800-736-0925 Email: [email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

How this recall developed

The company posted 3 announcements about this recall on fda.gov. They are kept together on this page: the products, codes and places listed above are combined from all of them, and the announcement text comes from the most recent English version.

  1. January 14, 2025 — First announcement. Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User Read it on fda.gov
  2. April 7, 2025 — Recall expanded. Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User Read it on fda.gov
  3. August 12, 2025 — Recall expanded. Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to Intermittent Cable Connection Concerns of the Dial with the SmartDrive MX2+ Motor. Users Must Use an Alternate Control Method for their SmartDrive MX2+ Power Assist Device. Read it on fda.gov

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • MX2-3DCK
  • s/power-assist/smartdrive-mx2plus-premium-wearables

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Max Mobility/Permobil — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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

Company contact: Max Mobility, LLC. — Consumers: Technical Support Team, 615-257-2930 — Media: Audra Watt, VP Marketing, Permobil Americas, 800-736-0925, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Max Mobility/Permobil medical devices recalled?

Due to potential safety and performance concerns Of these complaints, five (5) were for serious injuries, involving fractured or broken bones and a concussion.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number MX2-3DCK, s/power-assist/smartdrive-mx2plus-premium-wearables. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

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

Which states were affected?

The notice lists Connecticut.

Related recalls