Recall Z-1965-2025— Mobius Mobility LLC

Name: FDA recall Z-1965-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-24

Class II · Ongoing

Class II FDA medical device recall by Mobius Mobility LLC, initiated 2025-04-24. It names one FDA 510(k) clearance: K243442. Product: iBOT PMD with software version 01.05.24. Personal Mobility Device.. Reason: Software issue that could potentially lead to the device tipping over from Balance Mode..

Recalling firm: Mobius Mobility LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-04-24
Firm location: Manchester, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K243442 — iBOT® PMDMobius Mobility·cleared 2025-01-30

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

iBOT PMD with software version 01.05.24. Personal Mobility Device.

Reason for recall

Software issue that could potentially lead to the device tipping over from Balance Mode.

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