Z-2538-2025Class I

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

Name: Z-2538-2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive...
Creator: Max Mobility LLC
Published: 2025-08-12
License: https://open.fda.gov/license/

Permobil, AB / initiated 2025-08-12 / Open, Classified / root cause: design

FDA source

Max Mobility LLC began a recall of Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component on 2025-08-12. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2538-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-08-12
Posted: 2025-09-12
Recalling firm: Permobil, AB
Product: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Product code: ITI Wheelchair, Powered
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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
Quantity in commerce: 25,389 units
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 codes and lots: All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2538-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2538-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-12
Z-2539-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-12
Z-2540-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-12

Product code ITI

K151199Class IISmartDrive Wheelchair Power AssistMax Mobility, LLC / cleared 2015-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)