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Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial… recallZ-2538-2025 · Max Mobility LLC · initiated Aug 12, 2025

Class I Open, Classified All recalls posted in September 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Max Mobility LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.

FDA root cause category: Component design/selection

What the company is doing

On August 12, 2025, Permobil issued a "Urgent Medical Device Recall Expansion/Update" via email. This expansion supersedes the Class I recall ((Z-1116-2025, Z-1117-2025), initiated on December 20, 2024. Permobil asked consignees to take the following actions: 1. Immediately discontinue use of the SpeedControl dial to reduce the likelihood of a potentially hazardous or harmful situation. 1. Since all SpeedControl Dials are impacted by this recall, remove SpeedControl Dials from your sellable / distribution inventory 2. 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. 3.Immediately contact any customers you have distributed the device to and provide a copy of this notice. It is also recommended that this notice be posted in your clinic/facility 4. You are required to acknowledge that you received this Urgent Medical Device Recall letter. Please complete within 10 days of receipt of the letter. Please use the QR code below to access the field action portal to record your acknowledgement

Recall details

Recall number
Z-2538-2025
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Aug 12, 2025
Posted by the FDA
Sep 12, 2025
Recalling firm
Max Mobility LLC
Quantity
25,389 units
Product code
ITI
FDA submissions
K151199
Distribution
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: CAN, NZL, KOR, BMU, GBR, JPN, TWN, AUS, BRA, COL, MEX, ABW, SWE, CHL, ARG, HKG

Product description

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Code information (models, lots, serial numbers)

All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025

Other devices under the same FDA submission

2 devices cleared under K151199 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97356).

Sources and updates

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