Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Whee
Summary
The FDA issued a Class I for Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in co by Max Mobility LLC. Reason: 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 .
Details
Source
Device Recall
External ID
Z-2539-2025
Action Date
2025-09-24
Status
Ongoing
Category
device
Product Description
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Lot/Code Info: All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025
Quantity Affected: 15,834 units
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-12
Company
Lebanon, TN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 133 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Max Mobility LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Max Mobility LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Max Mobility LLC have FDA actions?
Max Mobility LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2539-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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