Recall Z-2540-2025— Max Mobility LLC

Name: FDA recall Z-2540-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-12

Class I · Ongoing

Class I FDA medical device recall by Max Mobility LLC, initiated 2025-08-12. It names one FDA 510(k) clearance: K151199. Product: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.. 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..

Recalling firm: Max Mobility LLC
Classification: Class I
Status: Ongoing
Initiated: 2025-08-12
Firm location: Lebanon, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K151199 — SmartDrive Wheelchair Power AssistMax Mobility, LLC·cleared 2015-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.