iBOT PMD with software version 01 — Class II medical device recall Z-1965-2025
Ongoing recall by Mobius Mobility LLC, reported 2025-06-18, distributed nationwide. Software issue that could potentially lead to the device tipping over from Balance Mode.
| Recall number | Z-1965-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mobius Mobility LLC, Manchester, NH, United States |
| Recall initiated | 2025-04-24 |
| Classified | 2025-06-12 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 442 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00857584008010 |
| Serial numbers | 0001108, 0001110, 0001121, 0001123, 0001128, 0001136, 0001137, 0001422, 0001438, 0001496, 0001505, 0001508, 0001516, 0001517, 0001519 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1965-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.