iotaSOFT Plus Drive Unit — Class III medical device recall Z-0288-2025
Completed recall by Iotamotion Inc, reported 2024-11-13, distributed in IA. Incorrect GTIN number.
| Recall number | Z-0288-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iotamotion Inc, Vadnais Heights, MN, United States |
| Recall initiated | 2024-09-12 |
| Classified | 2024-11-01 |
| Reported by FDA | 2024-11-13 |
| Distributed | IA |
| Quantity | 5 devices |
| UPC / GTIN / UDI-DI | 00850002960006 |
| Lot numbers | D500330 |
| Model numbers | IM-05 |
| Expiration dates | 2025-01-12 |
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.
Reason for recall
Incorrect GTIN number.
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-0288-2025. 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.