CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
iBOT PMD recalled by Mobius Mobility
Mobius Mobility is recalling iBOT PMD, distributed nationwide in the US. The recall was initiated on 24 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1965-2025
- FDA event ID
- 96834
- Recalling firm
- Mobius Mobility, Manchester, NH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Apr 2025
- FDA classified
- 12 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 24 Apr 2025 | Recall initiated by company | |
| 12 Jun 2025 | Classified by FDA | +49 days |
| 18 Jun 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software issue that could potentially lead to the device tipping over from Balance Mode.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Where it was distributed
US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.
Nationwide CaliforniaColoradoFloridaGeorgiaIndianaNorth CarolinaNew JerseyOhioPuerto RicoRhode IslandTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
Software issue that could potentially lead to the device tipping over from Balance Mode.
Which lots are affected?
Software Version 01.05.24; UDI (01) 00857584008010 (21) 0001108, (01) 00857584008010 (21) 0001110, (01) 00857584008010 (21) 0001121, (01) 00857584008010 (21) 0001123, (01) 00857584008010 (21) 0001128, (01) 00857584008010 (21) 0001136, (01) 00857584008010 (21) 0001137, (01) 00857584008010 (21) 0001422, (01) 00857584008010 (21) 0001438, (01) 00857584008010 (21) 0001496, (01) 00857584008010 (21) 0001505, (01) 00857584008010 (21) 0001508, (01) 00857584008010 (21) 0001516, (01) 00857584008010 (21) 0001517, (01) 00857584008010 (21) 0001519; Serial No. 0001108, 0001422, 0001438, 0001496, 0001505, 0001508, 0001516, 0001517, 0001519, 0001110, 0001121, 0001123, 0001128, 0001136, 0001137.
Where was it sold?
US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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