PlainRecordsMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC… and 2 more products
- 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 potentially resulting in minor or major injuries.
- Status
- Ongoing
- 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
- Enforcement report date
- Sept. 24, 2025
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed 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 potentially resulting in minor or major injuries.
- Distribution pattern
- 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
What this record is about
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“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.”Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component., FDA enforcement report, 2025-09-24. The caption is the record's own words.
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FDA device name: Wheelchair, Powered
Distributed in (FDA's record): Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming
3 products in this recall
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive…
- Product
- Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
- Quantity
- 25,389 units
- Codes and lots
- All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025
- Recall started
- Aug. 12, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Wheelchair, Powered
- Root cause (FDA)
- Component design/selection
- What the company told customers
- 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 number
- Z-2538-2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive…
- Product
- Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
- Quantity
- 15,834 units
- Codes and lots
- All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025
- Recall started
- Aug. 12, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Wheelchair, Powered
- Root cause (FDA)
- Component design/selection
- What the company told customers
- 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 number
- Z-2539-2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the…
- Product
- Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
- Quantity
- 8,413 units
- Codes and lots
- All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025
- Recall started
- Aug. 12, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Wheelchair, Powered
- Root cause (FDA)
- Component design/selection
- What the company told customers
- 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 number
- Z-2540-2025
This recall among the others
- FDA's enforcement report came 43 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Max Mobility: 1 other recall or notice on this site in the three years before this one (from Sept. 25, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-2538-2025, Z-2539-2025, Z-2540-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-2538-2025, Sept. 24, 2025. "Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC… and 2 more products." PlainRecords, https://plainrecords.com/recall/device/z-2538-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections