Class III — Iotamotion Inc
| Recalling firm | iotaMotion, Inc. |
|---|---|
| Registered facility | IOTAMOTION, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Completed |
| Reason | Incorrect GTIN number. |
| Product | iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. |
| Quantity | 5 devices |
| Distribution | Distribution was made to Iowa. There was no government/military/foreign distribution. |
| Initiated | 2024-09-12 |
| Classified | 2024-11-01 |
| Recall number | Z-0288-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Iotamotion Inc (Z-0288-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95462/
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