FDA Device recall Z-0288-2025
iotaSOFT Plus Drive Unit, REF IM-05
- FDA Device
- Class III
- completed
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class III recall of iotaSOFT Plus Drive Unit, REF IM-05 by Iotamotion, citing incorrect GTIN number.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0288-2025 |
| Classification | Class III |
| Status | completed |
| Initiated | 2024-09-12 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Iotamotion |
| Distribution | IA |
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
Incorrect GTIN number.
Identifiers
| code_info | Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0288-2025%22
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