Max Mobility LLC medical device recall: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97356
- Recall initiated
- Aug 12, 2025
- Classified by FDA
- Sep 12, 2025
- Posted in Enforcement Report
- Sep 24, 2025
- Recalling firm
- Max Mobility LLC
- Firm location
- Lebanon, TN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 12, 2025. FDA classified it 31 days later, on Sep 12, 2025. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: 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 Max Mobility LLC has 2 recalls in our records.
Recalled products (3)
Z-2538-2025 Class I Ongoing
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Codes / lots: All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025
Quantity: 25,389 units
Z-2539-2025 Class I Ongoing
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Codes / lots: All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025
Quantity: 15,834 units
Z-2540-2025 Class I Ongoing
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Codes / lots: All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025
Quantity: 8,413 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97356
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.